Toelatingsnummer 12899 N

 

Kontakt 320 SC  

 

12899 N

 

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

BESTRIJDINGSMIDDELEN

 

1 TOELATING

 

Gelet op de aanvraag d.d. 23 december 2004 (20040508 TG) van

 

MAKHTESHIM-AGAN HOLLAND B.V.

Arnhemseweg 87

3832 GK  LEUSDEN

 

 

 

tot verkrijging van een toelating als bedoeld in artikel 2, eerste lid, van de Bestrij­dings­middelen­wet 1962 (Stb. 288) voor het onkruidbestrijdingsmiddel, op basis van de werkzame stof fenmedifam

 

Kontakt 320 SC

 

gelet op de artikelen 3 en 4 van de Bestrijdingsmiddelenwet 1962,

 

BESLUIT HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN als volgt:

 

§ I  Toelating

1.      Het bestrijdingsmiddel Kontakt 320 SC wordt toegelaten in de zin van artikel 2, eerste lid, van de Bestrij­dings­middelen­wet 1962, onder nummer en datum dezes. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II dezes.

2.      De toelating geldt tot 28 februari 2015

 

§ II  Samenstelling, vorm en afwerking

Onverminderd hetgeen omtrent de samenstelling, vorm en afwerking van een bestrijdingsmiddel is bepaald in de Regeling samenstelling bestrijdingsmiddelen, moeten de samenstelling, vorm en fysische toestand van het middel alsmede de chemische en fysische eigenschappen daarvan overeenkomen met de bij de aanvraag tot toelating ingediende gegevens op basis waarvan de toelating is verstrekt.

 

§ III  Gebruik

Het bestrijdingsmiddel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I dezes onder A. is voorgeschreven.

 


§ IV Classificatie en etikettering

 

  1. De aanduidingen, welke ingevolge artikel 36 van de Wet milieugevaarlijke stoffen en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

Overeenkomstig artikel 15c, lid 1, onder b van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten:

 

-          aard van het preparaat: Suspensie concentraat

 

Overeenkomstig artikel 15e, onder b van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten:

 

-    Werkzame stof: fenmedifam

- Gehalte: 320 g/l  

 

 

Overeenkomstig artikel 14, leden 1, 2 en 3 van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten:

 

-          andere zeer giftige, giftige, bijtende of schadelijke stof(fen):  

-

 

  1. Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorge­schreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

a.      letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

b.      hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn.

 

c.      overeenkomstig artikel 14, lid 4 tot en met lid 13 van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten, letterlijk en zonder enige aanvulling, tenzij bij de veiligheidsaanbeveling anders is vermeld:

-    Gevaarsymbool:

-    Aanduiding:

 

 

Xi

Irriterend

 

 

N

Milieugevaarlijk

 

 

-          Waarschuwingszinnen:

Irriterend voor de huid.

Kan overgevoeligheid veroorzaken bij contact met de huid.

Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 


-          Veiligheidsaanbevelingen:

Middel en/of oplossingen ervan niet met metaal in aanraking brengen.

Draag geschikte handschoenen en beschermende kleding.

In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.

Deze stof en de verpakking als gevaarlijk afval afvoeren. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt:

1)      Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven.

2)      Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd.

3)      Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)

Voorkom lozing in het milieu. Vraag om speciale instructies/ veiligheidsgegevenskaart

 

d.      overeenkomstig artikel 14, lid 13 en lid 14 van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten, letterlijk en zonder enige aanvulling:

 

-          Specifieke vermeldingen:

-  

 

e.   n.v.t. 

 

f.        overeenkomstig artikel 15e, onder a van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten, letterlijk en zonder enige aanvulling:

 

'Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.'

 

g.   n.v.t. 

 

h.   n.v.t. 

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot toelating van het middel Kontakt 320 SC (12899 N), een middel op basis van de werkzame stof fenmedifam.Het middel wordt aangevraagd als onkruidbestrijdingsmiddel in de teelt van: suiker-, voederbieten en kroten; aardbeien in de volle grond; irissen; gezaaide boomkwekerijgewassen; bloemenzaad en Tagetes.

 

2.2 Informatie met betrekking tot de stof

Er zijn in Nederland reeds andere middelen op basis vande werkzame stof fenmedifamtoegelaten.

De werkzame stof fenmedifam is per 1 maart 2005 opgenomen in bijlage 1 van gewasbeschermingsrichtlijn 91/414/EEG. De einddatum van de werkzame stof fenmedifam is 28 februari 2015.   

 

2.3 Karakterisering van het middel

Kontakt 320 SC is een contactherbicide op basis van fenmedifam. Fenmedifam behoort tot de groep van de carbamaten. Fenmedifam werkt door het ingrijpen in de fotosynthese en wordt systemisch door de plant getransporteerd. Fenmedifam wordt opgenomen door het blad en transport vindt vooral plaats naar de bladgroenkorrels. Fenmedifam heeft geen bodemwerking en werkt vooral op tweezaadlobbige onkruiden.

De werkzame stof fenmedifam is zowel sec toegelaten als in combinaties met diverse andere werkzame stoffen.

 

2.4 Voorgeschiedenis

De aanvraag is op 31 december 2004 ontvangen; op 18 januari 2005 zijn de verschuldigde aanvraagkosten ontvangen. De aanvraag is op 2 juni 2005 inhoudelijk onvolledig bevonden. Op 29 juni 2005 en op 14 januari 2006 zijn ontbrekende gegevens geleverd. De aanvraag is op
10 november 2005 in behandeling genomen. Op 22 november 2005 werden de verschuldigde beoordelingskosten ontvangen. In de collegevergadering van 9 augustus 2006 zijn aanvullende vragen gesteld. Op 4 september 2006 zijn aanvullende gegevens ontvangen. Op 22 september 2006 zijn de aanvullend geleverde gegevens niet volledig bevonden. Op 17 november 2006 zijn ontbrekende aanvullende gegevens ontvangen. Nadat de gegevens volledig zijn bevonden zijn op 23 februari 2007 de aanvullende gegevens in behandeling genomen. Op 28 februari 2007 zijn de verschuldigde kosten ontvangen. De 48 weken termijn eindigt op 30 januari 2008.

 

3 RISICOBEOORDELINGEN 

 

3.1  Fysische en chemische eigenschappen

De geleverde gegevens geven in voldoende mate de mogelijkheid om op basis daarvan de identiteit van het middel vast te stellen, te specificeren en te karakteriseren. Er is vastgesteld dat de standaardgegevens voor milieu, toxicologische aspecten en risico’s met betrekking tot de fysisch-chemische eigenschappen beschikbaar zijn (artikel 3, lid 1, sub d Bmw 1962).

De beoordeling van de evaluatie van het middel en de stof staat beschreven in Bijlage II, Hoofdstuk 2. Physical and chemical properties behorende bij dit besluit.

 

3.2  Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuanalysemethoden zijn specifiek en gevoelig genoeg om te kunnen worden gebruikt voor het controleren van de betreffende plantaardige en dierlijke producten op het maximaal toegestane gehalte, en het monitoren van de verspreiding van de residuen in het milieu (artikel 3, lid 1, sub b en c Bmw 1962).

De beoordeling van de evaluatie van de analysemethoden staat beschreven in Bijlage II, Hoofdstuk 3. Methods of analysis behorende bij dit besluit.

 

3.3  Humane Toxicologie

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt:

-        de gezondheid niet schaadt of de veiligheid niet in gevaar brengt van degene die het middel toepast, en

-        de gezondheid niet schaadt of de veiligheid niet in gevaar brengt van diegenen, die na toepassing van het middel door verrichten van werkzaamheden daarmee of met de residuen daarvan in aanraking komen (artikel 3, lid 1, sub a, onderdelen 5 en 6 Bmw 1962).

Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Bijlage II, Hoofdstuk 4. Mammalian toxicology behorende bij dit besluit.

 

3.4  Residuen en risico voor de volksgezondheid

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt geen schadelijke uitwerking heeft op de gezondheid van de mens (artikel 3, lid 1, sub a, onderdeel 3 Bmw 1962).

De vastgestelde maximum residuniveaus en de beoordeling van het risico voor de volksgezondheid staan beschreven in Bijlage II, Hoofdstuk 5. Residues behorende bij dit besluit.

 

3.5  Gedrag in bodem, water en lucht

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt

-        geen schadelijke uitwerking heeft op het grondwater en)

-        geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met:

·       de plaats waar het bestrijdingsmiddel in het milieu terecht komt en wordt verspreid, met name voor wat betreft besmetting van het water, met inbegrip van drink- en grondwater en belasting van de bodem;

·       de gevolgen voor niet doel-soorten

(artikel 3, lid 1, sub a, onderdelen 9 en 10 Bmw 1962).

Het profiel milieu inclusief de beoordeling van het risico voor het milieu staat beschreven in Bijlage II, Hoofdstuk 6. Environmental fate and behaviour behorende bij dit besluit.

 

3.6  Ecotoxicologie

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt

-        geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met:

·       de plaats waar het bestrijdingsmiddel in het milieu terecht komt en wordt verspreid, met name voor wat betreft besmetting van het water, met inbegrip van drink- en grondwater en belasting van de bodem;

·       de gevolgen voor niet doel-soorten (artikel 3, lid 1, sub a, onderdeel 10 Bmw 1962).

Het profiel ecotoxicologie inclusief de beoordeling van het risico voor niet-doelwit soorten staat beschreven in Bijlage II, Hoofdstuk 7. Ecotoxicology behorende bij dit besluit.

 

3.7  Werkzaamheid

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt:

-        voldoende werkzaam is en

-        geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 3, lid 1, sub a, onderdelen 1 en 2 Bmw 1962).

De beoordeling van het aspect werkzaamheid staat beschreven in Bijlage II, Hoofddstuk 8. Efficacy behorende bij dit besluit.

 

3.8  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Kontakt 320 SCop basis van de werkzame stof fenmedifam voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 3 Bestrijdingsmiddelenwet 1962).

 


Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 8 van de Bestrijdingsmiddelenwet 1962 en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de Toelating van Bestrijdingsmiddelen (Ctb), Postbus 217, 6700 AE WAGENINGEN. Het Ctb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

Wageningen, 23 maart 2007

HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN,


(voorzitter)



HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE I bij het besluit d.d. 23 maart 2007 tot toelating van het middel Kontakt 320 SC, toelatingnummer 12899 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in:

a.      de teelt van suiker-, voederbieten en kroten, mits toegepast voor het sluiten van het gewas;

b.      de teelt van aardbeien in de volle grond, mits toegepast voor de bloei of na de oogst, dan wel na het uitplanten;

c.      de teelt van irissen;

d.      de teelt van gezaaide boomkwekerijgewassen;

e.      bloemenzaadteelt en

f.        de teelt van Tagetes.

 

Het middel is uitsluitend bestemd voor beroepsmatig gebruik.

 

Op percelen die grenzen aan watergangen is toepassing uitsluitend toegestaan met gebruik van een dop uit de driftreductieklasse van 75%.

 

Het is niet toegestaan dit middel met een luchtvaartuig toe te passen.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

 

Dit onkruidbestrijdingsmiddel is een contactherbicide. Toepassen op onkruiden met niet meer dan 2 echte blaadjes. De onkruiddoding wordt na 4-10 dagen zichtbaar. Bij aanwezigheid van veel kamille, kleefkruid, varkensgras, perzikkruid, waterpeper en opslagplanten van koolzaad spuiten in het kiemlobbenstadium van de onkruiden. Grasachtige onkruiden zijn weinig gevoelig. Wortelonkruiden worden niet bestreden. Voor zover er niet anders is aangegeven moet het middel in 200 tot maximaal 300 liter water per hectare worden verspoten bij een druk van minimaal 3 bar; dit geldt eveneens voor de tankmengingen.

 

Spuit met grondig schoongemaakte apparatuur. Voeg het middel pas toe als de tank ½ tot ¾ gevuld is met water. Vermijd het gebruik van kalk- of ijzerhoudend water. Spuit direct na gereedmaken van de spuitvloeistof en houd deze voortdurend in beweging.

 

Toepassingen

 

Suiker- en voederbieten:

Toepassen na de opkomst in of vanaf het volgende ontwikkelingsstadium van de biet:

 

Gestrekte kiemblaadjes
Dosering: 3 liter per hectare

 

Spuit bij onregelmatige opkomst of bij verzwakt gewas: 2 keer 1,5 liter in 200 liter water per hectare. Eerste bespuiting als tenminste 40.000 planten gestrekte kiemblaadjes hebben, tweede bespuiting 4-6 dagen later.

 


Tankmengingen:

Ter versterking van de contactwerking en ter verkrijging van werkingsduur. De aangegeven doseringen zijn per hectare.

 

Gestrekte kiemblaadjes:

Dosering: 3 liter Kontakt 320 SC + 1,5 liter Goltix SC per hectare

Zodra de eerste twee echte blaadjes van de bieten ca. 1 cm groot zijn en op de twee hiervoor genoemde tijdstippen geen Goltix werd toegepast:

Dosering: 1,5 liter Kontakt 320 SC + 1,5 liter Goltix SC per hectare.

 

Lage doseringen systeem:

Onafhankelijk van het gewasstadium tegen onkruiden in het kiembladstadium:

Dosering: 0,25-0,5 liter Kontakt 320 SC + 0,5-1 liter Goltix SC +  0,5-1 liter ethofumesaat (200 g/l) of 0,2-0,4 liter ethofumesaat (500 g/l) + 0,5-1 liter minerale olie (850 g/l) per hectare.

De toepassing herhalen indien opnieuw gekiemde onkruiden aanwezig zijn.

De hoogste dosering toepassen indien de onkruiden 1 à 2 echt blaadjes hebben ontwikkeld of als minder gevoelige onkruiden zoals zwaluwtong, varkensgras en/of kleefkruid voorkomen.

 

Rijenbehandeling:

Gebruik 35-40% van bovenstaande doseringen. Spuittank vullen voor spuitduur van ten hoogste 2 uur. Spuitvloeistof in beweging houden.


Kroten (rode bieten):

Toepassen na de opkomst zodra de kiemblaadjes van de krotenplanten volledig zijn gestrekt.

Dosering: 2-3 liter per hectare

Tankmenging:

Vanaf het moment dat de eerste 2 echte blaadjes van de kroten volledig zijn ontwikkeld.

Dosering: 1,5 liter Kontakt 320 SC + 3 liter Goltix SC per hectare

 

Aardbeien in de volle grond:

Toepassen:

  1. in het voorjaar voor de bloei van de aardbeien;
  2. na de oogst, of na het uitplanten in de zomer, zodra de planten goed zijn aangeslagen.

Dosering: 3 liter per hectare in 400 tot 500 liter water. Verspuiten met een grove druppel.

 

Gezaaide boomkwekerijgewassen:

Toepassen in een aantal gezaaide gewassen na opkomst vanaf het 2- bladstadium. Er moet rekening worden gehouden met tijdelijke groeiremming na een bespuiting.

Een deel van het sortiment verdraagt het middel, een ander deel niet. Raadpleeg dus, voordat tot een bespuiting wordt overgegaan (voorlichtingsmateriaal van) de fabrikant of de Voorlichtingsdienst.

Dosering: 3 liter per hectare (30 ml per are)

 

Bloemenzaadteelt:

Toepassen in:

Amaranthus: vanaf 2 kiemblaadjes van het gewas.             Dosering: 15 ml per are

Amaranthus: bij 2 à 3 echte blaadjes van het gewas.          Dosering: 30 ml per are; kans op enige groeiremming.

Lavatera: vanaf 2 blaadjes van het gewas.                          Dosering: 30 ml per are

Mesembryanthemum: vanaf 4-6 blaadjes van het gewas.  Dosering: 30 ml per are

Phlox drummondii: vanaf 2 kiemblaadjes van het gewas.    Dosering: 30 ml per are; tijdelijk kan groeiremming optreden.

 

In de teelt van andere bloemzaadteeltgewassen is gebruik van dit middel niet verantwoord.

 

Irissen:

Na opkomst van de irissen in het 2-bladstadium.

Dosering: 3 liter per hectare in 500 liter water (30 ml per are in 5 liter water).

Verspuiten met een grove druppel. Tijdelijk kan enige groeiremming optreden.

 

Tagetes:

Na opkomst van Tagetes als het gewas minimaal 4 cm hoog is, spuiten op pas gekiemde onkruiden.

Het middel dient altijd in combinatie met metamitron gespoten te worden.

Dosering: 1 tot 2 liter Kontakt 320 SC + 1-2 liter Goltix SC per hectare.

 

De hogere doseringen aanhouden indien het onkruid groter is dan het 2-4 bladstadium.

Toepassen met maximaal 400 liter water per hectare, op een droog gewas bij een temperatuur lager dan 20ºC en niet te felle zonneschijn.

 

Bij nieuw kiemende onkruidplantjes dient de bespuiting herhaald te worden.
Dosering: 1 liter Kontakt 320 SC + 1 liter Goltix SC per hectare.

 

Er kan enige bladverbranding van Tagetes optreden, dit herstelt echter snel.

 

 

Weersomstandigheden

Spuit tijdens groeizaam weer en bij voorkeur bij bedekte lucht op een droog, gezond groeiend gewas. Het dient ook tenminste enkele uren na bespuiting droog te blijven. Niet spuiten bij temperaturen boven 20ºC. In dat geval de bespuiting ’s avonds uitvoeren. Indien nachtvorst wordt verwacht de bespuiting uitstellen.

 

 




HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE II   RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        2

 

2.   Physical and chemical properties                  3

 

3.   Methods of analysis                                         9

 

4.   Mammalian toxicology                                      11

 

5.   Residues                                                            16

 

6.   Environmental fate and behaviour                19

 

7.   Ecotoxicology                                                    31

 

8.   Efficacy                                                               53

 

9.   Conclusion                                                        55

 

10.Classification and labelling                             56

 


1.         Identity of the plant protection product

 

1.1       Applicant

Makhteshim Agan Holland B.V.

Arnhemseweg 87

Postbus 355

3830 AK Leusden

 

1.2       Identity of the active substance

ISOCcommon name

[where relevant, it must be stated which variant (e.g. salt, ester) is present, and also the isomeric ratide naam van de stof zoals die het etiket komt, in het engelso]phenmedipham

Name in Dutch

[idem, in het nederlands]fenmedifam

Chemical name

methyl 3-(3-methylcarbaniloyloxy)carbanilate;
3-methoxycarbonylaminophenyl 3´-methylcarbanilate [IUPAC]

CAS nr

13684-63-4

EEG nr

237-199-0

 

The active substance is was included on March 1st 2005included ion the Annex 1 list of from directive 91/414/EC.

 

1.3       Identity of the plant protection product

Name

Kontakt 320 SC

Formulation type

SC

Content active substance

320 g/L pure phenmedipham

 

The formulation was not part of the assessment of the active substance for inclusion ion the Annex 1 list of 91/414/EC.

 

1.4       Function

The product is a herbicide

 

1.5       Uses applied for

Kontakt 320SC is claimed for the control of dicotyledonous weeds in sugarbeet and fodderbeet and tabledicotylodon weeds in sugar beet and fodder beet and table (red) beet, to be applied once ina dose of maximum 3 kg/ha or in the Low dosage system (Lage Dosering Systeem) of 3 applications with aLage Dosering Systeem (Low dosage system) of 3 application with dose of 0,25-0,5 l/ha per treatment, combined with ethofumesate, metamitron and mineral oil, strawberry, iris, sown tree nursery crops and the production of flower seed in a dosage of 3 kg/ha and in Tagetes in a dosage of 2 l/ha in combination with 2 liter Goltic SC.

 

Uses

Dose a.s.

(g a.s./ha)

Number of applications

Interval between applications

Application time (season and growth stage (BBCH))

Sugarbeet, fodderbeet

960

1

 

April-June (10-12)

Uses

Dose a.s.

(g a.s./ha)

Number of applications

Interval between applications

Application time (growth stage (BBCH) and season)

Sugar beet, fodder beet

960

1

 

April-June (10-12)

Sugarbeet, fodderbeet (row treatment)

384

1

 

April-June (10-12)

Sugar beet, fodder beet (row treatment)

384

1

 

April-June (10-12)

Sugarbeet, fodderbeet LDS-system

160

3

7-14

April-June

Sugarbeet, fodderbeet 1st 2 leaves 1 cm

480

1

 

April-June

Sugarbeet, fodderbeet 1st 2 leaves 1 cm (Row treatment)

192

1

 

April-June


 

Sugarbeet, fodderbeet LDS-system

160

3

7-14

April-June

Table beet

960

1

 

April-June (10)

Table (red) beet

960

1

 

April-June (10)

Table (red) beet first 2 leaves fully developed

480

1

 

April-June

Strawberry

960

1

 

April-June (10)

Irises

960

1

 

April-June (12)

Tree nursery crops

960

1

 

April-June

Production of flower seed

960

 

 

April-June (12

Tagetes

640

+ 1400 g a.s. metamitron

1

 

April-June (12)

Tagetes

640 + 1400 g a.s. metamitron

2 (second application 320 phenmedipham+ 700 metamitron)

 

April-June (12)

 

1.6       Background to the application

It concerns an application for authorization of a plant protection product.

 

1.7       Packaging details

 

1.7.1    Packaging description

Material:

HDPE

Capacity:

1L and 5L

Type of closure and size of opening:

63mm with screw cap

Other information

Packed in sets of 4x5L jerry cans in corrugated boxes

ADR compliant

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.                  Physical and chemical properties

 

2.1              2.1  Active substance: phenmedipham

Data about the identity and the physical and chemical properties are taken from the List of Endpoints (monograph, October 2003). Changes and/or additions are taken up in italics.

 

Identity

Active substance (ISO Common Name)

Phenmedipham

Chemical name (IUPAC)

methyl 3-(3-methylcarbaniloyloxy)carbanilate;
3-methoxycarbonylaminophenyl 3´-methylcarbanilate

Chemical name (CA)

3-[(methoxycarbonyl)amino]phenyl (3-methylphenyl) carbamate

CIPAC No

77

CAS No

13684-63-4

EEC No (EINECS or ELINCS)

EINECS: 237-199-0

FAO Specification (including year of                                publication)

AGP: CP/90, (1980); min. 97.0  ± 1 %

Minimum purity of the active substance as manufactured (g/kg)

min. 970 g/kg

Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)

None

Molecular formula

C16H16N2O4

Molecular mass

300.3

Structural formula

 

 

 

Physical-chemical properties

Melting point (state purity)

142.7 °C  (99.2 % pure)

Boiling point (state purity)

No boiling point, decomposition begins at 147 °C.

Temperature of decomposition

147 °C  (97 % tech.)

Appearance (state purity)

Colourless, crystalline powder, odourless.  (99.6% pure)

Relative density (state purity)

1.359 g/cm3 at 20 °C  (99.3 % pure)

Surface tension

71.2 mN/m at 20 °C  (98.5 % tech.)

Vapour pressure (in Pa, state temperature)

7 · 10 -10 Pa at 25 °C  (99.3 % pure)

Henry’s law constant (in Pa·m3·mol-1)

5 · 10 -8 Pa · m3 · mol –1 at 20°C

Solubility in water (in g/l or mg/l, state                                   temperature)

pH 3,4: 1,8 mg/l at 20 °C  (99.0 % pure)

Phenmedipham decomposes at neutral or basic pH.

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

All in g/l at 20 °C: toluene: 0.97; dichloromethane: 16.7; methanol: 36.2; acetone: 165; ethyl acetate: 56.3:   isooctane 0.16

Partition co-efficient (log Pow) (state pH and temperature)

3.59  at 22 °C and pH 4

No pH dependence

Hydrolytic stability (DT50) (state pH and temperature)

pH 5: DT50 = 119.5 h at 25 °C;
pH 7: DT50 = 14.5 h at 25 °C;
pH 9: DT50 = 0.16 h at 25 °C;

Dissociation constant

Phenmedipham does not dissociate.

UV/VIS absorption (max.) (if absorption >290 nm state εat wavelength)

lmax: 205 nm, emax: 59646 l mol-1 cm-1 
lmax: 237 nm, emax: 37848 l mol-1 cm-1 
lmax: 274 nm, emax: 2761 l mol-1 cm-1      at pH 6.2

Photostability (DT50) (aqueous, sunlight,  state pH)

Photochemically stable.

Quantum yield of direct photo-

transformation in water at λ > 290 nm

Photochemically stable.

Photochemical oxidative degradation in air

DT50= 6.7h

Flammability

Not to be considered as highly flammable.

Auto-flammability

148 oC

Oxidative properties

Not oxidising

Explosive properties

Not to be considered as explosive.

List-of-endpoints zoals gepubliceerd bij plaatsing op Annex-1, concept DAR of een vergelijkbare lijst op basis nationale gegevens

 

2.2              2.2   Plant protection product: Kontakt 320 SC

Data about plant protection product are taken from studies submitted by the applicant.

 

The range of the application concentration of the plant protection product is 0.08-1.5 %

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

Visual

GLP: Y

Homogeneous liquid

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

Visual

GLP: Y

Opaque white

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

Organoleptic

GLP: Y

Faint chemical odour (latex)

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

EEC A14

Statement

Not explosive based on the individual properties of the product’s components.

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

EEC A17

Statement

Not oxidising based on individual properties of the product’s components.

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

EEC A15

GLP: Y

485 oC

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

CIPAC MT 12.2 (EEC A9)

GLP: Y

> 79 oC

Acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

CIPAC MT31.2.1

GLP: Y

Acidity 0.17% H2SO4

pH of the pure product (undiluted): 3.44

Acceptable

B.2.2.10 (IIIA 2.4)

pH

CIPAC MT75.3

GLP : Y

1% dispersion : 4.15

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

EEC A5

GLP: Y

T = 40 oC : 29.2 mN/m

T = 25 oC : 29.4 mN/m

Dilutions :

0.5%v/v (20 oC) : 27.8 mN/m

1.5%v/v (20 oC): 28.1 mN/m

Acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

OECD 114 equivalent

GLP: Y

20 oC

Rotation speeds 2.52 to 158.8s-1

Dynamic viscosity 952 to 120 mPa.s

40 oC

Rotation speeds 2.52 to 158.8s-1

Dynamic viscosity 12 to 95 mPa.s

Acceptable

B.2.2.13 (IIIA 2.6)

Relative density

CIPAC MT3.3.2

GLP: Y

Density : 1.0977 g/cm3

Acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable

 

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: Y

CIPAC MT 46.3, 75.3, 31.2.1, 3.3.2, 47.2, 184, 185, 160, 148

Analytical method based on CIPAC method 77/TC/M3.2

 

 

CIPAC MT39.3

GLP: Y

The product was found to be stable for 14 days at 54 oC.

 

All relevant technical properties were determined. However, the suspensibility was not determined at the minimum and maximum proposed concentration for use and the persistence of foam was higher than the 60ml limit after 1 minute.

 

Stable for 7 days at 0 oC. After storage suspensibility, wet sieving and pH were determined.

Acceptable

 

 

 

 

 

 

 

 

 

 

 

 

Acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

GLP: Y

CIPAC MT 75, 31.1, 160, 161, 59.3, 148, 47, Gifap monograph No. 17,

Chemical stability

No significant decrease of active ingredient was observed after storage for 2 years at 20 oC.

Analytical method validation was included in the test report.

 

Physical stability

All relevant technical properties were tested and no significant changes were observed after storage for 2 years at 20 oC.

 

Packaging

The packaging proved suitable to its contents. The original containers as described in the test report were made of HDPE, which gives sufficient reason to believe the proposed packaging for the Dutch market is suitable for storage of the product.

Acceptable

B.2.2.16

(IIIA 2.8)

Wettability

 

Not applicable

 

B.2.2.17 (IIIA 2.8)

Persistent foaming

CIPAC MT47.2

GLP: Y

 

 

 

 

 

 

CIPAC MT47

GLP : Y

3L / 200L (1.5%v/v) dilution in CIPAC D water :

After 1 minute 77ml of foam persists, which may mean an increased operator risk. The instructions for use should include instructions to reduce foaming.

 

A second study, included in the shelf-life study also shows foam over the 60ml limit, although only slightly (61.8ml)

Acceptable.

 

The instructions for use include measures to reduce foaming.

 

 

 

 

Acceptable.

 

The instructions for use include measures to reduce foaming.

B.2.2.18

(IIIA 2.8)

SsSuspensibility

CIPAC MT184

GLP: Y

In CIPAC D water :

1L/200L (0.5%v/v): 97.5%

3L/200L (1.5%v/v): 96.5%

 

The test was not performed at the lowest concentration for use (0.08%). The results display a very high suspensibility and therefore results can be extrapolated.

Acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersionSpontaneity

CIPAC MT160

GLP: Y

In CIPAC D water after 5 minutes

12.5mL/250mL (5%v/v): 94.1%

Acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Wet sieve test

CIPAC MT185

GLP: Y

0.04% w/w residue on a 75 micron sieve.

Acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

 

Not applicable

 

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

Not applicable

 

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

Not applicable

 

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable

 

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable

 

B.2.2.28

(IIIA 2.8)

Flowability

 

Not applicable

 

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

CIPAC MT148

GLP: Y

Residue: 3.68%

Rinsed residue : 0.20%

Acceptable

B.2.2.30

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable

 

2.9.1

Physical compatibility with other products

Testing method of product physical compatibility (UK, 1986)

Mixing with the product Goltix and various other active substances (ethofumesate, mineral oil, etc.) is proposed in order to increase efficacy.

 

To prove these mixes do not give any problems during application concerning physical and chemical stability, tests were performed with tankmixes of Kontakt 320 SC with various other products.

 

The tank mixes proposed in the instructions for use form stable mixtures and are considered acceptable.

Acceptable

2.9.2

Chemical compatibility with other products

 

See 2.9.1

 

 

No mixing with other plant protection products or adjuvants is proposed other than described in the table above.Mixing with other products or adjuvantother than the abovementioned can therefore result in unexpected behaviour.

 

Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions.

 

2.3       Data requirements

No further data required.

 


 

3.                  Methods of analysis

 

Description and data about the analytical methods are taken from the List of Endpoints (Monograph, October 2003). Changes and/or additions are taken up in italics.

 

3.1.      Analytical methods in technical material and plant protection product

Technical as (principle of method)

HPLC, reversed phase (RP-18 ) column, UV detection at 238 nm, mobile phase: acetonitrile/water/dioxane.
(Corresponds CIPAC method 77/TC/M/3.2 (revised))

Impurities in technical as (principle of  method)

HPLC, reversed phase (RP-18 ) column, UV detection at 238 nm, mobile phase: acetonitrile/0.005 M pentanesulfonic acid Na-salt/dioxane.
Residual toluene by capillary GC-FID.
Residual water by Karl Fischer titration.

Preparation (principle of method)

HPLC method based on CIPAC 77/TC/M 3.2

 

Conclusion

The analytical methods haveare already been assessed in the monograph and are considered to be acceptable, with exception of the analytical method for the preparation. The method submitted by the applicant for determination of the active ingredient in the preparation was based on existing CIPAC methodology and considered acceptable.

 

3.2       Residue analytical methods

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

HPLC-MS/MS; LOQ: 0.05 mg/kg (phenmedipham)  in sugar beets

Confirmatory method: not required for LC-MS/MS

ILV: no; DFG S19 method is fully validated

 

DFG S19 multi residue method GLC/MSD; LOQ: 0.02 mg/kg (phenmedipham) in sugar beets

Confirmatory method: DFG multi method S 6-A

ILV: yes

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)

HPLC-MS/MS; LOQ: PMP 0.05 mg/kg (all products)
(and MHPC metabolite LOQ: 0.05 mg/kg (all products))
Confirmatory method: not required for LC-MS/MS

ILV: yes

Soil (principle of method and LOQ)

HPLC-MS/MS; LOQ: PMP 0.01 mg/kg, MHPC metabolite LOQ: 0.01 mg/kg)

Confirmatory method: not required for LC-MS/MS

Water (principle of method and LOQ)

HPLC- MS/MS; LOQ: PMP 0.01 mg/l, MHPC metabolite LOQ: 0.01 mg/l in both surface and drinking water

Confirmatory method: not required for LC-MS/MS

Air (principle of method and LOQ)

HPLC-UV; LOQ: 10 µg/m³ (phenmedipham)

Confirmatory method: HPLC-MS/MS method for water

Body fluids and tissues (principle of method and LOQ)

not required – not toxic or very toxic

Vanuit de toepassing (WGGA) dient een residuanalysemethode te worden geleverd voor waterige matrices (suikerbieten en voederbieten). De geleverde residuanalysemethode voldoet voor de waterige matrix.

Based on the proposed use of the plant productection product, the analytical methods for determination of residues in food/feed of plant origin are required to be validated for watery matrices (sugar beets, fodder beets, beetroot, strawberry).

 


 

Definition of the residue and proposed MRL’s for phenmedipham

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

phenmedipham

0.05 mg/kg (all), according to the Dutch Pesticide law

Food/feed of animal origin

phenmedipham

0.05 mg/kg (all), according to the Dutch Pesticide law

 

Required LOQ

Soil

phenmedipham and MHPC

0.,05 mg/kg (default)

Drinking water

phenmedipham and MHPC

0.1 µg/L (Dutch drinking water guideline)

Surface water

phenmedipham and MHPC

25 µg/L (NOEC for Daphnia Magna)

Air

phenmedipham

0.039 mg/m3 (derived from the AOEL (0.13 mg/kg bw/day) according to SANCO/825/00)

Body fluids and tissues

The active substance is not classified as (very) toxic thus no definition of the residue is proposed.

Not applicable

 

The residue analytical methods, included in the abovementioned List of Endpoints,  are suitable for monitoring of theabove MRLs.

 

TheDe residue analytical methods for water, soil and air, evaluated in the monograph, are acceptable and suitable for monitoring of the residues in the environment.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRLs and for monitoring of residues in the environment.

 

3.3       Data requirements

No further data requirements.

 

3.4       PhysicoPhysical-chemical classification and Labelling

 

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

 

Based on the profile of the substance, the provided toxicology of the preparation, the  characteristics of the co-formulants, the method of application, the following labeling of the preparation is proposed:

 

(The numeration in the table below is in accordance with the numeration in theDecision of the Board:)

1

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

 

2c)

Symbol:

Indication of danger:

 

R phrases 1

 

 

 

 

 

S phrases 2

 

 

 

 

2d)

Special provisions:
DPD-phrases
3

 

 

 

 

2f)

Plant protection products phrase:
DPD-phrase

DPD014

To avoid risk for man and the environment, comply with the instructions for use

2h) 5

Child-resistant fastening obligatory?

 

Tactile warning of danger obligatory?

Explanation:

Hazard symbol:

Risk phrases:

Safety phrases:

Other:

1 phrases originating from 67/548 (code R..), 91/414/EEC, annex IV (Code RS..) or nationally assigned phrases (code G..)

2 phrases originating from 67/548 (code S..), 91/414/EEC, annex V (Code SP..) or nationally assigned phrases (code V..)

3 phrases originating from 1999/45/EEC (code DPD..)

4 This phrase is to be mentioned for al plant protection products; to be removed when the labeling concerns biocides

5 Required only for preparations for the general public, to be removed for preparations for the professional user

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

Symbol(s):

Indication(s) of danger:

R-phrases

S-phrases

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

Tactile warning of danger obligatory?

 

Explanation:

Hazard symbol:

Risk phrases:

Safety phrases:

Other:

 

 


 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

S phrases

V31-NL

Do not bring (diluted) product into contact with metal.

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

V31-NL is assigned to products with a pH lower than 4, due to possible corrosive behaviour when brought into contact with certain types of metal.

Other:

-

 

 

4.                  Mammalian toxicology

 

 

List of End-points

The final list of endpoints presented below is copied from the final review report on phenmedipham. (SANCO/4060/2001 – final, d.d. 13 February 2004). When relevant, some additional remarks/information is given in italics.

 



Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)

Rate and extent of absorption:

Rapid. 85%, based on urinary excretion in 24 –30 h

Distribution:

Widely distributed, highest residues in blood (methylphenyl ring label)

Potential for accumulation:

Low potential for accumulation

Rate and extent of excretion:

Rapid. Over 90% within 24- 30 h

Toxicologically significant compounds:

Parent compound and metabolites. 3-aminophenol and 3-aminotoluene may be of special toxicological concern

Metabolism in animals:

Extensively metabolised. Oxidative/hydrolytic cleavage of parent molecule, hydroxylation of aromatic ring structures, acetylation of amino groups and further oxidation of methyl groups

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

>8000 mg/kg

Rat LD50 dermal

>2000 mg/kg

Rat LC50 inhalation

>7.0 mg/l (nose only)

Skin irritation

Non irritant

Eye irritation

Non irritant

Skin sensitization (test method used and result)

Not sensitising (M & K)

 

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Effects on red blood cells (methemoglobinemia and hemolytic anemia) and related effects (hemosiderin deposition in spleen, liver and kidneys)

Lowest relevant oral NOAEL / NOEL

150 ppm (13 mg/kg bw/day) (90-day, rat)

Lowest relevant dermal NOAEL / NOEL

No data. Not required

Lowest relevant inhalation NOAEL / NOEL

No data. Not required

 

Genotoxicity (Annex IIA, point 5.4)

Clastogenic in vitro. Non-genotoxic in vivo (mouse bone marrow: negative for chromosome aberrations and micronuclei induction; mouse spermatogonial cells: negative for induction of chromosomal aberrations)1

1 The genotoxic potential of phenmedipham was investigated in 13 in vitro studies (Ames test, mammalian cell gene mutation test in Chinese hamster lung fibroblasts V79 and mouse lymphoma cells, mammalian cytogenetic test in Chinese hamster ovary cells) and 5 in vivo studies (micronucleus test in mouse bone marrow and chromosome aberration test in NMRI mouse spermatogonial cells).

 


Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect

Effects on red blood cells (methemoglobinemia and hemolytic anemia) and related histophatological effects in spleen, liver and kidneys (increased weight, hemosiderosis, extramedullar hematopoiesis)

Lowest relevant NOAEL / NOEL

60 ppm (3 mg/kg bw/day) 2-year, rat)

Carcinogenicity

No carcinogenic potential

 

Reproductive toxicity (Annex IIA, point 5.6)

Target / critical effect – Reproduction:

Reduced pup weight at parentally toxic dose levels

Lowest relevant reproductive NOAEL / NOEL

25 mg/kg bw/day (two-generation, rat)1

Target / critical effect Developmental

Retarded ossification in rats and rabbits at maternally toxic dose levels

Lowest relevant developmental NOAEL / NOEL

Rabbit: 225 mg/kg bw/day

1 The NOAEL for parental and maternal toxicity were respectively 75 and 25 mg/kg bw/day based on reduced bodyweight.

Delayed neurotoxicity (Annex IIA, point 5.7)

 

No data. Not required.

 

Other toxicological studies (Annex IIA, point 5.8)

 

No data. Not required.

 

Medical data (Annex IIA, point 5.9)

 

Four different studies were supplied which reported cases of allergic dermatitis, photoallergic dermatosis, allergic rhinitis and toxic hepatitis in pesticide operators and field workers who had applied Betanal or Betamix formulations of phenmedipham

 


Summary (Annex IIA, point 5.10)

Value

Study

Safety factor

ADI:

0.03 mg/kg bw/day

2-year rat study

100

AOEL systemic:

0.13 mg/kg bw/day

90-day rat study

100

ARfD (acute reference dose)

Not allocated, not necessary

 

 

Dermal absorption (Annex IIIA, point 7.3)

 

1% (based on an absorption study in vivo in rat, and comparative in vitro penetration studies with rat and human skin) 1.

1 The dermal absorption study is performed with a OF (oil flowable) with 75 g/L phenmedipham. From the available studies it can be concluded that there was hardly no difference between the dermal absorption of the undiluted formulation (0.9%) and the spray concentration (0.2%). Therefore, the dermal absorption will be considered 1% (worst case).

 

Data requirements active substance

No additional data requirements are identified.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Kontakt 320 SC does not need to be classified on the basis of its acute oral (LD50 rat > 2000 mg/kg bw), dermal (LD50 rat > 4000 mg/kg bw), and inhalation toxicology (LC50 rat > 5 mg/L).

The formulation Kontakt 320 SC is considered irritating to skin and needs to be classified as R38 ‘Irritating to skin’.

The formulation Kontakt 320 SC is not classifiable as an eye irritant.

The formulation Kontakt 320 SC is positive in a Maximisation test for skin sensitisation and needs to be classified as R43 ‘May cause sensitisation by skin contact’.

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

It is assumed that the dermal absorption of Kontakt 320 SC (320g/L) will not be higher than the dermal absorption of the oil flowable (OF) formulation of the dermal absorption studies. In the available studies the undiluted formulation and spray concentration are tested (1:50). For the current notification diverse spray concentrations are prescribed (1:50 - 1:3000). Furthermore, the dermal absorption of the spray concentration (0.2%) was even lower than the undiluted formulation (0.9%). Therefore, a dermal absorption of 1% (worst case) is considered for the present risk assessment.

 

4.3       Available toxicological data relating to non-active substances (IIIA 7.4)

Other formulants: no reason for concern.

 

4.4       Exposure/risk assessments

 

Overview of the intended uses

An application was submitted for the authorisation of the plant protection product Kontakt 320 SC, a herbicide based on the active substance phenmedipham, in sugarbeet, fodderbeet, table beet, strawberries (open field), tree nursery crops, irises, production of flower seed and Tagetes.

 

Kontakt 320 SC is a SC formulation and contains 320 g/L phenmedipham.

 

The formulation Kontakt 320 SC is applied by mechanical downward spraying in sugarbeet, fodderbeet, table beet, strawberries (open field), tree nursery crops, irises, production of flower seed and Tagetes. The formulation is applied once during the period April – June with a maximum dose of 5 L formulation / ha. Therefore, a semi-chronic exposure duration is applicable for the operator (contract workers included).

 

Calculation of the AOEL

Since phenmedipham is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of
0.13 mg/kg bw/day (= 9.1 mg/day for a 70-kg operator), based on the 90-day oral toxicity study in dogs, is applied (see List of Endpoints).

 

4.4.1    Operator exposure/risk

Exposure to phenmedipham during mixing and loading and application of Kontakt 320 SC is estimated with models. The exposure is estimated for the unprotected operator. In the Table below the estimated internal exposure is compared with the systemic AOEL. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

The maximum dose in the field is 1.6 kg/ha phenmedipham.

 

Table T.1 Internal operator exposure to phenmedipham and risk assessment for the use of Kontakt 320 SC.

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanica downward spraying in sugarbeet, fodderbeet, table beet, strawberries (open field), tree nursery crops, irises, production of flower seed and Tagetes

Mixing/

Loading

Respiratory

0.08

9.1

< 0.01

Dermal

3.2

9.1

0.35

Application

Respiratory

0.13

9.1

0.01

Dermal

0.48

9.1

0.05

 

Total

3.9

9.1

0.43

a     External exposure was estimated by EUROPOEM. Internal exposure was calculated with:

·       biological availability via the dermal route: 1% (see 4.2)

·       biological availability via the respiratory route: 100% (worst case)

b     The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

 

4.4.2    Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

 

4.4.3    Worker exposure/risk

Shortly after application it is not necessary to perform any re-entry activities during which intensive contact with the treated crop will occur. Therefore no worker exposure is calculated.

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

 


Operator exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to phenmedipham as a result of the application of Kontakt 320 SC in sugarbeet, fodderbeet, table beet, strawberries (open field), tree nursery crops, irises, production of flower seed and Tagetes.

 

Bystander exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to phenmedipham during application of Kontakt 320 SC in sugarbeet, fodderbeet, table beet, strawberries (open field), tree nursery crops, irises, production of flower seed and Tagetes.

 

Worker exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in sugarbeet, fodderbeet, table beet, strawberries (open field), tree nursery crops, irises, production of flower seed and Tagetes due to exposure to phenmedipham after application of Kontakt 320 SC.

 

4.5       Appropriate mammalian toxicology and operator exposure end-points relating to
the product and approved uses

See List of end-points.

 

4.6       Data requirements

Based on this evaluation no additional data requirements are identified.

 

4.7       Combination toxicology

The registrant provided information with regard to acute toxicity of the substances used in tankmixtures with Kontakt 320 SC. The substances used in the tankmixtures were metamitron (Goltix 700 SC), ethofumesaat and mineral oil. The combinations will not lead to a stronger classification than based on the individual substances (conform calculations rules 99/45/EC).

 

Furthermore, with regard to the chronic toxicity of the tankmixtures, the registrant refers to recent evaluations of Goltix SC and Betanal Quattro.

 

The critical effect of phenmedipham is haemolytic anaemia. Ethofumesate and metamitron induce effects on the liver. These effects could possibly be correlated to the induction of biotransformation enzymes. Based on the differences in toxicological profile, no extra risk is expected for the combined exposure to phenmedipham and ethofumesate or to phenmedipham and metamitron.

 

Metamitron and ethofumesate both induce effects on the liver. These effects could possibly be correlated to the induction of biotransformation enzymes. In that case these substances could in principle influence the toxicological effects on each other (induce or deduce).

The estimated combined exposure to metamitron (risk-index = 0.64) and ethofumesaat (risk-index=0.26) results in a risk-index of 0.9 (based on the risk assessment of Goltix Super; risk-indices are adjusted for the dose/ha as described in the GAPs). Therefore, no extra risk is expected for the combined exposure to metamitron and ethofumesate, even if an additive effect will be induced by the simultaneous exposure to both substances.

 


4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification)

 

Symbol:

-

Indication of danger: -

 

Risk phrases

-

-

 

Proposal for the classification and labelling of the formulation concerning health

 

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labelling of the preparation is proposed:

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xi

Indication of danger:

Irritant

R phrases

38

Irritating to skin.

 

43

May cause sensitisation by skin contact.

S phrases

36/37

Wear suitable protective clothing and gloves.

 

46

If swallowed, seek medical advice immediately and show this container or label.

Special provisions:
DPD-phrases3

-

 

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

S2, S13, S20/21 are not obligatory for formulations intended for professional use only.

S24 and S39 are not obligatory for formulation labelled with R38 and R43.

Other:

-

 

 

5.                  Residues

The list of endpoints presented below is the most recent available.

 

List of End-points

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

Root vegetables (sugar beet), leafy crops (spinach), fruits (strawberry), pulses (pea)

Rotational crops

-

Plant residue definition for monitoring

phenmedipham

Plant residue definition for risk   assessment

phenmedipham

Plant residue definition for risk assessment

phenmedipham

Conversion factor (monitoring to risk            assessment)

-

 

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

Cow and hen

Animal residue definition for monitoring

MHPC expressed as phenmedipham

Animal residue definition for risk assessment

phenmedipham and MHPC

Conversion factor (monitoring to risk assessment)

-

Conversion factor (monitoring to risk assessment)

1 *

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

potential to accumulate

* Phenmedipham was included in the residue definition for unclear reasons since it was not found in animal tissue. A conversion factor of 1 is used in the EU.

 

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

 

-

 

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

 

Parent compound is stable at –10 oC for at least 5 months in processed commodities of sugar beets (cosettes, dry pulp and molasses).

Parent compound is stable at –20 oC for at least 24 months in sugar beets.

 

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock ³ 0.1 mg/kg diet/day:

Ruminant:

Yes

Poultry:

Yes

Pig:

no studies

Muscle

-

4 ng/g (skeletal muscle)

3 ng/g (skeletal muscle/ breast)

-

Liver

0.112 mg/g (MPC label)

0.015 mg/g (PC label)

16 ng/g

-

Liver

112 ng/g (MPC label)

150 ng/g (PC label)

16 ng/g

-

Kidney

0.14 mg/g (MPC label)

0.15 mg/g (PC label)

-

-

Kidney

140 g/g (MPC label)

150 ng/g (PC label)

-

-

Fat

-

7 ng/g (peritoneal fat)

-

Milk

0.008 mg/g (MPC label)

0.018 mg/g (PC label)

-

-

Milk

8 ng/g (MPC label)

18 ng/g (PC label)

-

-

Eggs

-

16 ng/g

-

 

Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)

ADI

0.03 mg/kg bw

ARfD

Not allocated

 

5.1       Summary of residue data

 

5.1.1    Metabolism in plants

Besides data from the DAR, the notifier has access to a metabolism study in strawberries, submitted by Bayerthe stakeholder for Herbasan SC (12424 N). This study was evaluated in C155.3.8.the decision of April 1st, 2005, based on the board meeting of C155.3.8, d.d 09.03.2005. The main residue in strawberry is parent phenmedipham, consistent with the EU-established plant residue definition.

 

5.1.5    Residue data

Sugar beet, fodder beet

In the Draft assessment report (DAR) for phenmedipham, 154 supervised residue trials in sugar beet and 30 in fodderbeet in Northern Europe are available. The intented use for this application is equal to the supported use in the DAR  (maximal 960 g ai/ha/season). A sufficient number of residue trials is available.

For sugar beet the analysed residue values range from <0.01 to 1.0 mg/kg and from <0.01 to 1.2 mg/kg for roots and leaves, respectively. For fodder beet the analysed residue values range from <0.02 to <0.1 mg/kg and from <0.02 to <0.05 mg/kg for roots and leaves, respectively.

For the application of authorisation, 5 additional supervised residue trials in sugar beet have been submitted. Since the use and residues were consistent with trials in the DAR, these studies were not further evaluated.

 

Beetroot

In the Draft assessment report (DAR) for phenmedipham, 21 supervised residue trials in beetroot in Northern Europe are available. The intented use for this application is equal to the supported use in the DAR (maximal 906 g ai/ha/season). A sufficient number of residue trials is available.

The proposed MRL for beetroot is In March 2006, SANCO approved a harmonised EU-MRL of 0.1 mg/kg based on these trials.0.1 mg/kg.

 

Strawberries

In the Draft assessment report (DAR) for phenmedipham, 27 supervised residue trials in strawberries in Northern Europe are available. The trials were performed according to the intended use (maximal 960 g ia/ha/season). A sufficient number of residue trials is available. The proposed MRL for strawberry is 0.1 mg/kg.

In March 2006, SANCO approved a harmonised EU-MRL of 0.1 mg/kg based on these trials.

 

5.1.9    Calculation of the ADI and the ARfD

The ADI is based on the NOAEL of 3 mg/kg bw/d in the 2-year rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.03 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

No ARfD is derived. derived since phenmedipham shows no acute toxic properties.

 

5.2       Maximum Residue Levels

In March 2006, SANCO voted positively on a proposal for the following EU-MRLs:

 

MRLs

MRL

(mg/kg)

The following MRLs were set for phenmidipham and were published in directive 2006/62/EC:

 

product

MRL (mg/kg)

Strawberries

0.1

Beetroot

0.1

Spinach

0.5

Globe artichokes

0.2

Oilseeds

0.1*

Tea

0.1*

Hops

0.1*

All other plant commodities

0.05*

All animal commodities

0.05*

 

Although the official EU-directive has not yet been published, it is considered appropriate to use these MRL values for this application, since publication is expected shortly.

The product Kontakt 320 SC complies with theexpected MRL Directive.

 

These MRLs do not need to be notified to EU Member States and the EU Commission, pending the publication of the final directive. since they are covered by directive 2006/62/EC

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the National Theoretical Maximum Daily Intake (NTMDI) was carried out using the National Dutch diet and theexpected harmonised EU-MRLs of those commodities on which use is authorised nationally.beet, strawberry, spinach, artichoke and animal products. Calculation of the NTMDI shows that 0.81.8 % and 6.4 % of the ADI is used for the general population and for children, respectively.

 

Risk assessment for acute exposure through diet

Since no ARfD is derived, a calculation of the National Estimated Short Term Intake (NESTI) is not necessary.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to phenmedipham is currently expected.

 

5.4              5.4   Data requirements

-None.

 

 

6.                  Environmental fate and behaviour

 

In the Dutch Pesticide Law the Uniform Principles are implemented in the RegulationOrder of Uniform Principles for Plant protection products (BUBG). This RegulationOrder is also the legal basis for the Dutch specific criteria.

 

List of Endpoints Fate/behaviour 

Phenmedipham is an old substance, placed on ANNEX I since April 2004. For the risk assessment the final List of endpoints is used. Additions are placed in italicss.

 

 


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

 

PMP: Mineralization after 100 days

 

 

PMP: Mineralization after 100 days

 

CO2 evolved:

13.3 – 16.5 %  of AR within 120 days, AP 14C-labelled, low temperature/low moisture (n=1)

9.7 – 11.3 %  of AR within 120 days, phenoxy ring –U-14C labelled (n=3)

 

MP: Non-extractable residues after 100 days

 

63.6 – 64.1 % of AR within 120 days, AP 14C-labelled, low temperature/low moisture (n=1)

71.3 – 73.8 % of AR within 120 days

phenoxy ring –U-14C labeled (n=3)

 

Relevant metabolites - name and/or code, % of applied (range and maximum)

MHPC max 14 % of AR at day 14 (n=1)

APMP max  4 % of AR after 56 days (n=1)

(label position AP)

MHPC max 54 % at day 5 (n=1, ring-U-labelled)

 

MHPC: Mineralization after 100 days

From MHPC: ca. 10 % CO2 within 7 days (n=3)

 

MHPC: Non-extractable residues after 100 days

From MHPC: 80-83 % within 7 days (n=3)

 

 

 

Route of degradation in soil - Supplemental studies(Annex IIA, point 7.1.1.1.2)

 

 

Anaerobic degradation

 

CO2 evolved 6.6 % of AR,

NER 74.3 % of AR after 97 days,

MHPC max 19 % of AR after 32 days

(label position AP, n=1)

 

Soil photolysis

 

 

 

Soil photolysis

 

DT50 79 hours on irradiated soil

photochemical products:

3-aminophenol and 3-methoxycarbonylaminophenol

max 17.8 % of AR (sum of all polar products)

after 105 hours of irradiation

(n=1)

 

           


 

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Method of calculation

laboratory: 1st order kinetics

computer program by Timme

 

Laboratory studies (range or median, with n value,

with r2 value)

 

PMP

DT50lab (22ºC, aerobic):  14.1 days (n=1, r2 = 0.934)

Normalised to 20 °C by using Q10 of 2.2: 16.4 days

DT50lab (20ºC, aerobic):  26, 42, 43 d, mean=37 days (n=3, r2 = 0.932 - 0.953)

 

DT90lab (22ºC, aerobic):  47 days (n=1, r= 0.934)

Normalised to 20 °C by using Q10 of 2.2: 55 days

DT90lab (20ºC, aerobic):  85, 138, 143 days (n=3, r= 0.932 – 0.953)

 

DT50lab (11ºC, aerobic): 25 days,

DT90lab (11ºC, aerobic): 105 days

 

PMP

DT50lab (22ºC, anaerobic): 12.5 days (n=1, r2 = 0.934)

DT90lab (22ºC, anaerobic): 42 days (n=1, r2 = 0.934)

Metabolites:

MHPC

 

DT50lab (22ºC, aerobic): 12 days (n=1, r2 = 0.748)

DT90lab (22ºC, aerobic):  38 days (n=1, r2 = 0.748)

DT50lab (20ºC, aerobic): 0.1, 0.2, 0.3 days (n=3,

r2 = 0.992 - 0.999)

DT90lab (20ºC, aerobic):  1.2, 2.3, 2.9 days (n=3,

r2 = 0.992 - 0.999)

MHPC

DT50lab (20ºC, anaerobic): 49 days (n=1, r= 0.930)

DT90lab (20ºC, anaerobic): 161 days (n=1, r= 0.930)

APMP

DT50lab (22ºC, aerobic): 16.7 days (n=1, r2 = 0.993)

DT90lab (22ºC, aerobic):  55.5 days (n=1, r= 0.993)

APMP

DT50lab (20ºC, anaerobic): 70 days (n=1, r2 = 0.982)

DT90lab (20ºC, anaerobic): 231 days (n=1, r2 =0.982)

degradation in the saturated zone

 no data submitted nor required

Field studies(state location, range or median with

n value)

first order kinetics, DT50f:

Germany, bare soil, four sites:

5.8 days at pH 5.0,

9.0 days at pH 6.9,

15.7 days at pH 7.1,

39.9 days at pH 6.0, 

mean 17.6 days (n=4, rnot available, 1st order)

 

USA, California, one site:

sandy loam, on red beet  stage 4-6 leaf:

13.3 days at pH 7.0 (n=1, r2 not available, 1st order)

 

metabolites:  no DT50 values calculated in the field studies

 

DT90f: Germany, sites described above:

range 30 - 133 days, mean 82 days (n=4 , rnot available, 1st order)

 

For PECsoil calculation the median DT50f of 15.5 days from the German field studies was used.

 

For FOCUS gw modelling the DT50lab of 25 days was used for PMP, and 7 days for MHPC.

Soil accumulation and plateau concentration

no data submitted nor required

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

PMP

 

 

 

 

 

 

MHPC

 

 

 

 

 

 

 

pH dependence (yes / no) (if yes type of

dependence)

Koc:

PMP:

657, 934, 1072, mean = 888, 1/n = 0.821, 0.865, 0.854

(soil samples, n = 3, equilibrium time 2.5 hours)

469, 728, mean = 599, 1/n = 0.82, 0.84

(sediments, n=2, equilibrium time 3 hours)

 

Koc:

MHPC: 212, 138, 58, 470, mean = 220, 1/n  = 0.515, 0.699, 0.949, 0.805 (n = 4, one outlier excluded)

 

Kd:

MHPC: 0.57 - 4.8

 

Yes, due to the hydrolysis processes which indirect affect the adsorption of parent. No dependence for the metabolites.

 

For FOCUS gw modelling with FOCUS_PEARL v. 1.1.1  following median Kom values were used:

PMP: 422, 1/n = 0.84

MHPC: 101, 1/n = 0.752

 

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching

PMP: 

 

 

 

 

 

 

 

 

 

 

 

 

PMP:

 

 

 

 

 

 

 

 

 

 

 

PMP:

 

 

 

 

 

 

 

 

MHPC:

 

 

1) Guideline: US EPA subdiv. N, para 163.1

Precipitation:  920 ml corresponding to 50.8 cm rainfall in 10 days (92 ml/d)

Soils: 2 soils, label  positions AP and T

Use rate: 0.825 kg/ha (AP) and 1.1 kg/ha (T)

Leachate: total residue 0.33 - 0.45 % of AR in leachates, not characterized further

Soil columns: total residue 88.1 – 92.6 % of AR in soil columns (mainly in the top 5 cm),  NER 43.1 – 53.1 % and 34.9 – 60.4 % extractable of it

Volatiles 3.72 – 7.27 % of AR during the leaching period.

 

2) Guideline: US EPA subdiv. N, para 163.1

 Precipitation:  560 mm in 5 days

Soil: 2 soils, label positions AP and T

Use rate 1.65 kg/ha

Leachate: total residue 0.6 - 2.3 % of AR in leachates, not characterized further

Soil columns: total residue 89.5 – 95.4 % of AR in soil columns (mainly in the top 10 cm), extractable 26 – 64 % of it, mainly unchanged parent

Volatiles not trapped.

 

 

3) Guideline:  BBA

Precipitation: 200 ml/day for 2 days

Soils: 3 soils, label position AP

Use rate: 1.5 kg/ha

Leachate: total residue <0.5 % of AR in leachates, not characterized further

Soil columns: total residue  > 93 % of AR, mainly in the top 5 cm.

 

Guideline:  TNO in-house method

Precipitation: 140 ml/day for 3 days, corresponding to 30 cm of rainfall in 3 days

Soils: 2 soils, humic sand and loam

Use rate: 0.5 mg MHPC/column

 Leachate: 47.2 - 47.7 % of AR in leachates in the loam soil, not detected in the humic sand soil

Soil columns: In the humic sand the main part of the activity remained in the soil layers 12-24 cm, in the loam soil the activity was evenly distributed to the layers 6-30 cm, and only traces were located in the top 5 cm.

Aged residues leaching

 

1) Guideline:  BBA

Soils: 1 soil, German standard soil 2.1

Use rate:  960 g/ha, label position T

Aged at 20 degrees C, 40 % MWHC, for
33 days

Precipitation:  2 days irrigation of 200 mm

Leachate: 0.48 % of AR was found in the leachate, not characterized further

Soil column: 96.2 % of AR remained in soil, mainly in the top 10 cm

Volatiles: 5.7 % of AR.

 

2) Guideline:  EPA Vol 40, No 123, Part II, 1975

Soils: 2 soils, German standard soils 2.2 and 2.3

Use rate:  1.25 kg/ha, label position AP

Aged at 25-30 degrees C, 70 % MWHC, for
30 days

Precipitation:  45 days irrigation of 125 mm/day

Leachate:  0.58 and 1.66 % of AR was found in the leachates, not characterized further

Soil column: 99.1 – 112.9 % of AR remained  in the soil, mainly in the top 6 cm. The aged soil was not analysed further for the metabolites.

 

3) Guideline:   EPA Vol 40, No 123, Part II, 1975

Soils: 2 soils, German standard soils 2.2 and 2.3

Use rate: 1.65 kg/ha on soil 2.2 and 1.25 kg/ha on soil 2.3, label position T

Aged at 25-30 degrees C, 75 % MWHC, for
30 days

Precipitation:  45 days irrigation of 125 mm/day

Leachate:   1.37 - 1.83 % of AR was found in the leachates, not characterized further

Soil column: 72.9 – 88.7 % of AR remained in the soil, mainly in the top 5 cm. The aged soil was not characterized further for the metabolites.

Lysimeter/ field leaching studies

 

1) Location: UK

Study type: lysimeter

Soils: loamy sand, low content of organic matter

Number of applications: one single application of 0.942 kg/ha  in the first year, study continued over 2 years

Crops: sugar beet + wheat

Average annual rainfall: 757 mm (1st year),
948 mm (2nd year)

Average annual leachate volume: 200 mm/ first year (25 % of the precipitation), 445 mm/ second year (47 % of the precipitation)

% radioactivity in the leachate (max/year): after 2 years totally 0.8 - 1.1 % of AR was leached

Peak annual average concentrations: total radioactive residues 1.28 – 1.9 mg/l in the first year, 1.1 – 1.33 mg/l in the second year  (40 % of AR in leachate attributed to humic acid type fragments and up to 27 % incorporated with naturally occurring compounds),  MHPC 0.006 mg/l, PMP could not be detected in any of the samples (LOD = 0.03 mg/l as a.s.equivalents).

 

2) Location: Germany

Study type: lysimeter

Soils: loamy sand with low organic matter content

Number of applications:  1.0 kg/ha either once or in two successive years, study continued for up to 3 years

Crops: sugar beet (1 or 2 successive years) + wheat

Average annual rainfall: 860 mm/year (cumulative sum of 2582 mm within 3 years)

Average annual leachate volume: 428 mm

% radioactivity in the leachate (max/year): after 2 years totally 0.22 - 0.32 % of AR was leached

Peak annual average concentrations: total radioactive residues 0.314 – 0.805 mg/l (water soluble humic acid-type components, due to the low radioactivity the further characterization was not possible). MHPC was calculated as <0.01 mg as equivalents/l. (LOQ = 0.017 mg/l for PMP and 0.010 mg/l for MHPC).

 

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

            DT50                    DT90                   r2

pH 4:   259 d                   861 d                -0.9726

pH 5:     47 d                   156 d                -0.9958

pH 7:     12 h                     39 h                -0.9922

pH 9:       7 min                  24 min           -0.9860

(25 oC, 1st order kinetics)

Hydrolysis products:

MHPC formed:

pH 4: max 8.0 % of AR after 672 h

pH 5: max 38.0 % of AR after 720 h

pH 7: completely after 72 h

pH 9: completely after 30 min

 

MHPC is hydrolytically stable at pH 4, 5, 7, 9 under sterile conditions and at 50 oC over 120 h.

Photolytic degradation of active substance and

relevant metabolites

no degradation (artificial light source, λ > 290 nm)

Readily biodegradable (yes/no)

no

Degradation in    - DT50 water

water/sediment    - DT90 water

 

                            - DT50 whole system

                          

                            - DT90 whole system

 

 

MHPC:               - DT50 water

 - DT90 water

                          

                            - DT50 whole system

                          

                            - DT90 whole system

 

 

Mineralisation

NER in sediment

 

 

 

 

Distribution in water / sediment systems (active

substance)

 

 

 

 

 

 

Distribution in water / sediment systems

(metabolites)

0.1 – 0.3 days (Öt/1st order, r2 = 0.989, 0.544, n=2 )       

0.6 – 3.4 days (Öt/1st order, r2 = 0.989, 0.544, n=2 )

 

0.11, 0.12, 0.18 days (1st order kinetics, r2 = 0.942 – 0.978, n=3)

0.38, 0.40, 0.60 days  (1st order kinetics, r2 = 0.942 – 0.978, n=3)

 

10-21 days (apparent DT50 determined visually)

not available

 

10.6, 23.9, 24.9 days (1st order kinetics, r2 = 0.942 – 0.978, n=3)

35.3, 79.4, 82.8 days (1st order kinetics, r2 = 0.942 – 0.978, n=3)

 

CO2: 14 - 30 % of AR at study end after 126 days (n=2)

NER in sediment: max.55 - 78 % of AR after 70/35 days,

50 % at study end after 126 days, n=2)

 

1 - 2 % of AR in water phase and

51 - 55 % in sediment after 126 days

(non-sterilised samples, 2 label positions, 2 systems),

44 - 51 % of AR in water and

39 - 44 % in sediment after 126 days (sterilised samples, 1 label position, 2 systems).

 

MHPC: 60 - 70 % of AR within 1 - 2 days

              1 % of AR after 126 days

 

Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)

Direct photolysis in air

not studied, no data required

Photochemical oxidative degradation in air (DT50)

6.7 hours derived by the Atkinson method of calculation

Volatilization

from plant surfaces: no data

 

from soil: no data

 

Major Components of the Environmental Residue (Annex IIA, point 7.3)

Relevant to the environment

 

 

Soil: phenmedipham, MHPC

Water: phenmedipham, MHPC

Air: phenmedipham

 

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study)

no data submitted nor required

Surface water (indicate location and type of study)

no data submitted nor required

Ground water (indicate location and type of study)

no data submitted nor required

Air (indicate location and type of study)

no data submitted nor required

 

 


Metamitron and ethofumesaat

 

Endpoints Metamitron and ethofumesaat

For the use in beets, beetroots and Tagetes also several tank mixes are applied for. For the use in tagetes,Tagetes, Kontakt is only applied for as a tank mix in combination with metamitron. Therefore, combination effects are assessed for each aspect for the use in tagetes.Tagetes. For other tankmixes, only aquatic combination toxicity is considered (decision of the Board, 25-07-2005).

Metamitron is an old substance, not yet placed on ANNEX I. No DAR is available. For the risk assessment the most recent endpoints are used (C156.3.10, 04/2005). Ethofumesaat is an old substance, placed on ANNEX I. For the combination toxicology in water, relevant endpoints are taken from the most recent list of endpoints (05/2002). Considering the low toxicity of mineral oil for aquatic organisms, combination toxicology will not be taken into account for this substance.

 

 

endpoint

Metamitron

Ethofumesaat

soil

DT50 (days)

30

n.v.t.

 

Kom (L/kg)

100

78

water

DT50 (days)

25

182

Vapour pressure

 

8.6·10-7 Pa (25°C)

6.5·10-4 Pa (25°C)

Solubility in water

 

1700000 mg/L

50 mg/L

Molar mass

g/mol

202.2

286.3

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

The following laboratory DT50 values are available for the active substance phenmedipham: 42, 26 and 43 days (average 37 days). The mean DT50-value of the a.s. can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO2.

 

For the metabolite MHPC the following DT50-values are available: 12, <3, and <3 days (average 6 days).

Herewith, the standards for persistence as laid down in the RegulationOrder of Uniform Principles for Plant protection products (BUBG) are met.

 

PECsoil

The concentration of phenmedipham and MHPC (54%, molar mass 167.2) in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m3. See Table M.1 for input values and results.

 

Table M.1 PECsoil calculations (5 cm)

Use

Substance

Rate

[kg a.s./ha]

Frequency

Fraction on soil

PECsoil

5 cm

[mg a.s./kg]

(Sugar)beets

Phenmedipham

0.96

2

0.8

1.97

 

MHPC

0.29

2

0.8

0.50

Beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

0.96

1

0.8

1.02

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

0.96

1

0.8

1.02

MHPC

0.29

1

0.8

0.31

Tagetes

Phenmedipham

0.64

2

0.8

1.28

Tagetes

Phenmedipham

0.64

1

0.8

0.68

 

MHPC

0.19

2

0.8

0.29

 

MHPC

0.19

1

0.8

0.20

 

Metamitron

1.4

2

0.8

2.76

 

Metamitron

1.4

1

0.8

1.49

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.2.

 

6.1.2    Leaching to shallow groundwater

The leaching potential of the a.i. (and metabolites) is calculated in the first tier according to the RUUBG, using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. The new decision tree for leaching including the new model GeoPEARL has been released for use in risk assessment at the end of 2004. The methodology as described in the report "The new decision tree for the evaluation of pesticide leaching from soils", A.M.A van der Linden, J.J.T.I. Boesten, A.A. Cornelese, R. Kruijne, M. Leistra, J.B.H.J Linders, J.W. Pol, A. Tiktak and A.J Verschoor, RIVM report 601450019/2004, RIVM, Bilthoven (2004) has to be used. Input variables are the actual worst-case application rate [2 x 0.96 kg/ha], the crop sugarbeets and an interception value appropriate to the crop of 0.2. For metabolites all available data concerning substance properties are regarded. Metabolites are modelled as parent. The application rate is corrected for formation rate and molecular weight relative to the parent substance. The following input data are used for the calculation:

 

PEARL:

 

Active substance:

Mean DT50 for degradation in soil (20°C):  37 days

Mean Kom (pH-independent): 522 L/kg.

 

Saturated vapour pressure: 7.0x 10-10 Pa (25°C)

Solubility in water: 0.0018 g/L (20°C)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

Mean DT50 for degradation in soil (20°C):  6 days

Mean Kom (pH-independent): 129 L/kg.

 

Molecular weight: 167.2 g/mol

Formation fraction: 54 % formation * 0.56 (g/mol M1/g/mol parent)=0.30

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for the a.s. phenmedipham and the metabolite MHPC following the worst-case application in Beets,(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris, see Table M.2.

 

Table M.2 Leaching of a.s. phenmedipham and metabolite MHPC as predicted by PEARL 2.2.2 for theworst case application in beets.(sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris.

Use

Substance

Rate substance

Frequency

Interval

Fraction

on soil

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

Beets

Phenmedipham

MHPC

0.96

0.29

2

2

4

4

0.2

0.2

<0.001

<0.001

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

MHPC

0.96

0.29

1

1

-

-

0.2

0.2

<0.001

<0.001

 

Results of Pearl 2.2.2. using the Kremsmünster scenario are examined against the standard of 0.01 µg/l. This is the BUBG standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2 it reads that the expected leaching based on the PEARL-model calculations for the a.s. phenmedipham and its metabolite MHPC for the worst-case application is smaller than 0.01 µg/L. All other proposed applications haveThe application in Tagetes has lower expected leaching concentrations. Hence, the applications meet the standards for leaching.

 

Lysimeter/field leaching studies

Two lysimeter studies are available in the monograph. In both studies, the concentrations of phenmedipham and MHPC could not be detected or were < 0.01 µg/L. These lysimeter studies are not standardised to the Dutch conditions. Since no leaching is expected, this is not necessary.

 

Monitoring data

There are no data available regarding the presence of the substance phenmedipham in groundwater.

 

Conclusions

The proposed application of the product complies with the requirements laid down in Annex VI of Council directive 91/414/EECOrder of Uniform Principles for Plant protection products (BUBG) concerning persistence and leaching in soil.

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water

The exposure concentrations of the active substance phenmedipham and metabolite MHPC in the surface water are estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percen­tage depends on the use. Concentrations in surface water are calculated using the model TOXSWA. For the active substance and the metabolite the following input is required (all on the basis of mean values):

 

TOXSWA:

Active substance:

DT50 for degradation in water at 20°C:  0.14 days

DT50 for degradation in sediment at 20°C: 10000 (default).

 

Kom for suspended organic matter: 522 L/kg

Kom for sediment: 352 L/kg

 

Saturated vapour pressure: 7.0x 10-10 Pa (25°C)

Solubility in water: 0.0018 g/L (20°C)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

DT50 for degradation in water at 20°C:  21 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Kom for suspended organic matter: 129 L/kg

Kom for sediment: 129 L/kg

 

Molecular weight: 167.2 g/mol

Formation fraction: 70% formation * 0.56 (g/mol M1/g/mol parent)=0.392

 

Other parameters: standard settings TOXSWA

TOXSWA:

Active substance:

Mean DT50 for degradation in water at 20°C:  0.14 days

DT50 for degradation in sediment at 20°C: 10000 (default).

 

Mean Kom for suspended organic matter: 522 L/kg

Mean Kom for sediment: 352 L/kg

 

Saturated vapour pressure: 7.0x 10-10 Pa (25°C)

Solubility in water: 0.0018 g/L (20°C)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

Mean DT50 for degradation in water at 20°C:  21 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Mean Kom for suspended organic matter: 129 L/kg

Mean Kom for sediment: 129 L/kg

 

Molecular weight: 167.2 g/mol

Formation fraction: 70% formation * 0.56 (g/mol M1/g/mol parent)=0.392

 

Ethofumesate

Mean DT50 for degradation in water at 20°C:  182 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Mean Kom for suspended organic matter: 78 L/kg

Mean Kom for sediment: 78 L/kg

 

Saturated vapour pressure: 6.5 x 10-4 Pa (25 ºC)

Solubility in water: 0.05 g/L (25 ºC)

Molecular weight: 286.3 g/mol

 

Metamitron:

Mean DT50 for degradation in water at 20°C:  25 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Mean Kom for suspended organic matter: 100 L/kg

Mean Kom for sediment: 100 L/kg

 

Saturated vapour pressure: 0.86 x 10-6 Pa (20 °C)

Solubility in water: 1700 g/L (20 °C)

Molecular weight: 202.2 g/mol

 

Other parameters: standard settings TOXSWA

 

Because there is no standard method to determine separate degradation rates in water and sediment from the water/sediment study, the DT50 system is used for the water phase and degradation in the sediment is assumed to be zero, which is simulated using a DT50 value of 10000 days.

 

On the instructions for use, drift reduction of 75% is prescribed.

 

In Table M.3, the drift percentages and calculated surface water concentrations for the active substance phenmedipham and its metabolite MHPC for each intended use are presented.

 

Table M.3 Overview of surface water concentrations for active substance and metabolite MHPC following spring application

Use

Substance

Rate a.s.

[kg/ha]

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

 

 

 

 

spring

 

spring

 

spring

 

Sugarbeets

Phenmedipham

MHPC

2 x 0.96

2 x 0.375

1

4.56

3.36

 

0.19

2.66

 

0.14

2.46

 

Sugarbeets  (aircraft application)

Phenmedipham

MHPC

2 x 0.96

2 x 0.375

5

22.81

16.81

 

0.97

13.45

 

0.73

12.37

 

Beetroots, strawberries, tree nurseries, flowerseeds, iris

Phenmedipham

MHPC

0.96

0.375

1

4.56

1.78

 

0.096

1.39

 

0.072

1.29

 

Sugarbeets and beetroots (aircraft application)

Phenmedipham

MHPC

0.96

0.375

5

22.79

8.95

 

 

0.48

7.01

 

 

0.36

6.52

 

 

Sugarbeets, beetroots, strawberries, tree nurseries, flowerseeds, iris

Phenmedipham

MHPC

0.96

0.375

0.5

2.28

1.78

 

0.048

1.39

 

0.036

1.29

 

Tagetes

Phenmedipham

MHPC

Metamitron

2 x 0.64

2 x 0.251

2 x 1.4

1

3.04

2.18

12.31

 

0.13

1.71

10.08

 

0.097

1.55

9.15

 

Tagetes

Phenmedipham

MHPC

Metamitron

0.64

0.251

1.4

0.5

1.52

0.60

3.33

 

0.032

0.36

2.69

 

0.024

0.32

2.52

 

Additional tank mixes

 

 

 

 

 

 

 

Sugarbeets

Phenmedipham

Metamitron

2 x 0.96

2 x 1.4

1

4.56

12.64

 

0.19

10.39

 

0.14

9.58

 

Sugar beets

Phenmedipham

Metamitron

Ethofumesaat

0.16

0.70

0.20

1

0.76

3.33

0.95

 

0.016

2.68

0.85

 

0.012

2.51

0.82

 

Sugarbeets

Phenmedipham

Metamitron

Ethofumesaat

0.16

0.70

0.20

0.5

0.38

1.67

0.48

 

0.008

1.34

0.43

 

0.006

1.26

0.41

 

Sugarbeets + beetroot

Phenmedipham

Metamitron

0.48-0.96

2.1

1

2.28-4.56

9.99

 

0.048-0.096

8.04

 

0.036-0.072

7.53

 

Sugarbeets + beetroot

Phenmedipham

Metamitron

0.96

2.1

0.5

2.28

5.00

 

0.048

4.02

 

0.036

3.77

 

* calculated according to TOXSWA

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.2.

 

Monitoring data

There are no data available regarding the presence of the substance phenmedipham in surface water.

 

Drinking water criterion

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Act Administrative Law)) that the Ctb should for an authorisation, on the basis of the scientific and technical knowledge, considering the data submitted with the application, also test against the drinking water criterion as regards surface water intended for drinking water production. A mathematical model for this aspect is not available. This means that possibly available data cannot be taken into account adequately. It is therefore not possible to arrive at a scientifically well-based assessment of an expectation for this criterion. The Ctb has not been given the instruments for testing surface water from which drinking water is produced against the drinking water criterion. In order to meet the Court decision, however - from which it can be concluded that the Ctb should make an effort to arrive at a judgement on this point – and as transitional period, to prevent that not a single authorisation can be granted in the period during which a model is being developed and data need to be generated for the application for authorisation, the Ctb has investigated whether the product under consideration and the active substance could give cause for concern about the drinking water criterion.

 

From the general scientific knowledge collected by the Ctb about the product and its active substance, the Ctb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the BUBG are met.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

Phenmedipham

The vapour pressureof phenmedipham is 7.0x 10-10 Pa at 25°C. The Henry constant is 5 x 10-8 Pa x m3 mol-1 at 20°C. The half-life in air is 6.7 hours

 

At present there is no framework to assess fate and behaviour in air of plant protection products.

 

6.4       Appropriate fate and behaviour end-points relating to the product and approved uses

See List of End-points.

 

6.5       Data requirements
None.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

1.       the active substance phenmedipham meets the standards for per­sis­tence in soil as laid down in the RegulationOrder of Uniform Principles for Plant protection products (BUBG).

2.       Metabolite MHPC meets the standards for per­sis­tence in soil as laid down in the RegulationOrder of Uniform Principles for Plant protection products (BUBG).

3.       all proposed applications of the active substance phenmedipham meet the standards for leaching to the shallow groundwater as laid down in the BUBG.

4.       all proposed applications of metabolite meet the standards for leaching to the shallow groundwater as laid down in the BUBG.

5.       all proposed applications of the active substance phenmedipham meet the standards for surface water destined for the production of drinking water.

 

 

7.                  Ecotoxicology

 

In the Dutch Pesticide Law the Uniform Principles are implemented in the RegulationOrder of Uniform Principles for Plant protection products (BUBG). This RegulationOrder is also the legal basis for the Dutch specific criteria.

 

List of Endpoints Ecotoxicology

Phenmedipham is an old substance, placed on Annex I of Directive 91/414/EEC since April 2004. For the risk assessment the final List of endpoints is used. Additions are placed in italicss.

 

Effects on Non-target Species

 

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to mammals

rat: LD50 >320 mg a.i./kg body weight (formulation >2000 mg/kg)

Acute toxicity to birds

mallard duck: LD50 and NOEL >2100 mg/kg body weight

mallard duck & japanese quail: LD50 >2500 mg/kg body weight, NOEL 2500 mg/kg

as in the first study with mallard no effects were found, the higher NOEL value from the last study could be used in the risk assessment

Dietary toxicity to birds

mallard duck : NOEC 2000 mg/kg feed

bobwhite quail: NOEC 5000 mg/kg feed

Reproductive toxicity to birds

bobwhite quail: NOEC 1200 mg/kg feed

Reproductive toxicity to mammals

3-generation rat study: NOAEL 100 mg/kg corresponding to 6.8 mg PMP/kg b.w./day

 

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2)

 

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,  Annex IIIA, point 10.2)

 

 

Group

Test substance

Time-scale

Endpoint

recalculated based on initially measured concentrations

Toxicity

(mg/l)

 

 

 

Laboratory tests

 

 

PMP:

 

 

 

 

 

 

Rainbow trout

technical phenmedipham

96 hours

LC50

1.71

 

 

Rainbow trout

Betanal

(157 g PMP/l)

96 hours

LC50

6.9

1.1 (a.i.)

 

 

Rainbow trout

technical phenmedipham

21 days

NOEC

0.32

 

 

Daphnia magna

technical phenmedipham

48 hours

EC50

0.41

 

 

Daphnia magna

Rubenal

(160 g PMP/l)

48 hours

EC50

5.7

0.9 (a.i.)

 

 

Daphnia magna

technical phenmedipham

21 days

NOEC

0.061

 


 

Daphnia magna

Betanal

 (157 g PMP/l)

21 days

NOEC

0.025 (a.i.)

Chironomus riparius

technical phenmedipham

28 days

NOEC

0.37

Selenastrum capricornutum

green alga

PMP frame formulation

(16.5 % PMP)

 

72 hours

EbC50

(based on nominal values due to the unclear reporting in the original study, however used in the risk assessment as being the lowest value)

0.086 (a.i.)

Lemna minor

technical

phenmedipham

14 days

EbC50

NOEC

0.23

0.028

MHPC:

 

 

actual measured concentrations close to nominal values, therefore results are based on nominal concentrations:

 

Rainbow trout

technical MHPC

96 hours

LC50

75

Daphnia magna

technical MHPC

48 hours

EC50

14

Pseudokirchneriella subcapitata 

green alga

technical MHPC

96 hours

EC50

30

Microcosm or mesocosm tests

no data

Bold values are used in the TER calculations.

                                  

Bioconcentration

Bioconcentration factor (BCF)

121 – 321; 165 (whole fish)

Annex VI Trigger: for the bioconcentration factor

100

Clearance time           (CT50)

                      (CT90)

17 hours

not calculated

 

Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)

Acute oral toxicity

>100 µg/bee (product containing 160 g PMP/l)

 >16 µg/bee (a.i., calculated based on the PMP-content of the product)

Acute contact toxicity

50 µg/bee

 

Field or semi-field tests

Semi-field (tent) testing on Phacelia with 8.75 %  and 17.5 %  test solutions of a PMP formulation was performed with a conclusion:  not dangerous to bees.

 

The honey bee data on PMP is poor. However, as bees do not forage on crops where  uses are intended, the exposure is not likely and the risk is considered as low. Therefore no further studies are required.

 


Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)

Species

Stage

Test

Substance

Dose

(kg as/ha)

Endpoint

Adverse effect1

Annex VI

Trigger

Laboratory tests

Typhlodromus pyri

protonymphs

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

mortality

 

 

mortality

0 %

 

 

0 %

30 %

Aphidius rhopalosiphi

adults on glass plate

 

 

 

 

extended, adults on barley seedlings

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

 

480 g PMP/ha

 

960 g PMP/ha

mortality

 

 

mortality

 

 

mortality

fecundity

 

mortality

fecundity

63 %

 

 

43 %

 

 

7 %

+ 2 %

 

0 %

35 %

30 %

 

 

 

 

 

 

 

Poecilus cupreus

adults

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

mortality

feeding activity

mortality

feeding activity

0 %

+ 15 %

 

0 %

15 %

30 %

Chrysoperla carnea

larvae

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

mortality +

fecundity

 

mortality +

fecundity

 12.96%

 

 

 6.18 %

30 %

Syrphus

corollae

larvae – development

 

formulation

160 g/l

4.375 %

corresp. to 2800 g PMP/ha

mortality

development

 38 %

30 %

Coccinella

septem-punctata

larvae

formulation

160 g/l

4.3 %

corresp. to

ca. 2800 g PMP/ha

predatory

behaviour

 33 %

30 %

Coccinella

septem-punctata

larvae

formulation

160 g/l

4.3 %

corresp. to

ca. 2800 g PMP/ha

predatory

behaviour

 33 %

30 %

Erigone atra

spiders

adults

formulation

160 g/l

1440 g PMP/ha

mortality

behaviour

feeding

  0 %

  0 %

+ 5 %

30 %

Chrysopa carnea

larvae -

development

Betanal

(157 g/l)

2.25 %

corresp. to ca. 1400 g PMP/ha

mortality

development

  0 %

  0 %

30 %

Trichogramma cacoeciae

adults

Betanal

(157 g/l)

2.25 %

corresp. to ca. 1400 g PMP/ha

parasiting

behaviour

 29 %

30 %

Poecilus cupreus

adults

Betanal Plus (16.35 % PMP)

1430 g/ha

mortality

0 %

30 %

Bembidion lampros

adults

frame formulation

160 g/l

1440 g/ha

mortality

0 %

30 %

4 species of ground dwelling spiders

adults

Betanal

(157 g/l)

0.5 %

corresp. to ca. 314 g PMP/ha

mortality

0 %

30 %

Aleochara bilineata

adults

formulation (160 g/l)

1400 g/ha

parasiting behaviour

+ 10 %

30 %

 

1Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effect percentages (i.e. increase of e.g. reproduction) and a – sign for mortality effect percentages (i.e. decrease of mortality).

 

Field or semi-field tests

No data submitted nor required.

 

The effects seen with A. rhopalosiphi, S. corollae, C. septempunctata and T. cacoeciae are on borderline. However, in all studies where any effects were seen the studied concentrations are well above the recommended field rates, and therefore the effects are considered as acceptable.

 

Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)

Acute toxicity

LC50 = 244 mg/kg (TOP 2 frame formulation),

corresponding to 36 mg/kg PMP

Reproductive toxicity

NOEC = 5 kg PMP/ha, corrected by the factor of 2 for the organic carbon content of the substrate

è    2.5 kg PMP/ha, corresponding to 3.33 mg a.i./kg soil

è    refined NOEC 10.35 mg a.i./kg soil (actual application amount and actual soil bulk density)

 

Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)

Nitrogen mineralization

In a lab study no effects with the normal and 10 x maximum field use rate (corresponding to soil concentration of ca. 1.3 and 13 mg PMP/kg soil) compared to control in two soils.

 

In a field study the nitrification rate was in one soil 43 to 30 % lower in the treated soil compared to the unsprayed soil after 2 weeks and at harvesting, when PMP formulation (1 kg PMP/ha) was sprayed as a tank mixture with ethofumesate (0.75 kg/ha).  In the other soil the nitrification rate was 58 % higher in the treated soil compared to control. The use rate in this study corresponds to soil concentration of ca. 1.3 mg PMP/kg soil.

Carbon mineralization

In the previous study slight reversible effects (ca 20 %) on soil respiration was observed with a normal field use rate  (1 kg pmp/ha) when sprayed as a tank mixture with ethofumesate. Soil biomass was 28 - 38 % lower in the treated samples at  harvesting.

 

Effects on other non-target organisms (flora and fauna) believed to at risk (Annex IIA, point 8.6.)

seven weed species

Lowest EC50 achieved to Stellaria media with post emergence application of 4.5 g PMP/ha.

 

Effects on biological sewage treatment (Annex IIA, point 8.7.)

Pseudomonas putida

No effects with concentrations up to 2.4 mg/l.

 

Sewage treatment plants are not likely to be exposed as a result of field uses, as intended for PMP.

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to ecotoxicological data

N, R50-53, S60-61

 

Definition of residues (Annex IIA, point 10)

with regard to ecotoxicological data

 

phenmedipham

MHPC

 

Formulation Kontakt 320 SC

For the formulation Kontakt 320 SC (+ 320 g phenmedipham/L) several studies are available. These are summarized and evaluated by the RIVM (report 10555a00, 06/2006).

 


Toxicity aquatic organisms

 

Acute toxicity to algae

Substance

Species

Method

Duration

[h]

Criterion

Value

[mg/L]

Value

[mg as/L]

Remarks

Kontakt 320 SC

Scenedesmus subspicatus

static

72

ErC50

8.11

2.4

During the study metabolite MHPC was detected

 

 

 

 

EbC50

2.35

0.82

 

 

 

 

NOErC

< 0.49

< 0.15

 

 

 

 

NOEbC

< 0.49

< 0.15

 

Chronic toxicity to Daphnia

Substance

Species

Method

Duration

[d]

Criterion

Value

[mg/L]

Value

[mg as/L]

Remarks

Kontakt 320 SC

Daphnia magna

semi-static

21

NOEC

0.0772

0.0229

During the study metabolite MHPC was detected

 

Chronic toxicity to fish

Substance

Species

Method

Duration

[d]

Criterion

Value

[mg/L]

Value

[mg as/L]

Remarks

Kontakt 320 SC

Oncorhynchus mykiss

flow-through

21

NOEC

2.78

0.823

During the study metabolite MHPC was detected

 

Toxicity terrestrial organisms

 

Toxicity to non-target arthropods

Formulation1

Species

Method

Dose

 

[L/ha]

Dose

[g as/ha]

Parameter

Adverse effects2

[%]

LR50

[g as/ha]

Formulation1

Species

Method

Dose

 

[L/ha]

Dose

[g as/ha]

Parameter

Adverse effects2

[%]

L(E)R50

[g as/ha]

Kontakt 320 SC

Typhlodromus pyri

Lab.test

3

960

Mortality

Reproducion

17.2

0.7

>960

Kontakt 320 SC

Typhlodromus pyri

Lab.test

3

960

Mortality

Reproduction

17.2

0.7

>960

Kontakt 320 SC

Aphidius rhopalosiphi

Lab.test

3

960

Mortality

78.6

 

Kontakt 320 SC

Aphidius rhopalosiphi

Ext. Lab.test

0.12

38

Mortality

Reproducion

13.3

603

 

Kontakt 320 SC

Aphidius rhopalosiphi

Ext. Lab.test

0.12

38

Mortality

Reproduction

13.3

603

 

Kontakt 320 SC

Aphidius rhopalosiphi

Ext. Lab.test

0.32

102

Mortality

Reproducion

14

313

 

Kontakt 320 SC

Aphidius rhopalosiphi

Ext. Lab.test

0.32

102

Mortality

Reproduction

14

313

 

Kontakt 320 SC

Chrysoperla carnea

Lab.test

3

960

Mortality

Reproduction

-7.7

-4

 

Kontakt 320 SC

Pardosa sp.

Lab.test

3

960

Mortality

Consumption

10.3

14.0

 

Kontakt 320 SC

Aleochara bilineata

Lab.test

3

960

Parasitization

Reproducion

10.8

7.7

 

Kontakt 320 SC

Aleochara bilineata

Lab.test

3

960

Parasitization

Reproduction

10.8

7.7

 

Kontakt 320 SC

Poecilus cupreus

Lab.test

3

960

Mortality

Consumption

3.3

+88

 

Additional study (summarized and evaluated by the CTB)

Kontakt 320 SC

Aphidius rhopalosiphi

Ext. Lab.test

0

0

Mortality

Reproduction2

0

 

 

 

 

 

0.1875

0.06

Mortality

Reproduction2

0

n.a.

 

 

 

 

0.375

0.12

Mortality

Reproduction2

7

n.a.

 

 

 

 

 

0.750

0.24

Mortality

Reproduction2

0

+11

 

 

 

 

1.50

0.48

Mortality

Reproduction2

3

12

 

 

 

 

3.00

0.96

Mortality

Reproduction2

0

+19

>0.96

>0.96

 

1 Formulation Kontakt 320 SC = 320 g phenmedipham/kg

 

2Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

3 There is no clear explanation for the differences between the studies. Both studies showed low reproduction in the control, although the second study had more valid control replicates and is therefore considered more reliable than the first study. Both studies, however, fulfilled the validity criteria.

 

4 Reproduction data did not meet the validity criteria

 

Acute toxicity to earthworms

Substance

Species

Soil type

OM

[%]

Criterion

Value

[mg/kg]

Value

[mg as/kg]

Kontakt 320 SC

Eisenia fetida

OECD artificial

10

LC50

> 1000

> 325.6

 

Chronic toxicity to earthworms

Substance

Species

Soil type

OM

[%]

Criterion

Value

[L/ha]

Value

[kg as/ha]

Kontakt 320 SC

Eisenia fetida

OECD artificial

10

NOEC

  30

  9.54

 

Toxicity to micro organisms

Substance

Soil type

Dose1

 

[mg as/kg]

Dose

 

[kg as/ha]

Duration

 

[d]

Process

Maximal

effect

[%]

After...

 

[d]

Kontakt 320 SC

loamy sand

12.8

9.6

28

dehydrogenase

-12.75

28

 

loam

12.8

9.6

28

dehydrogenase

-5.24

28

 

loamy sand

12.8

9.6

91

N-cycling

+19.012

14

 

loam

12.8

9.6

91

N-cycling

+4.892

0

1: based on soil bulk density 1500 kg/m3 and 5 cm depth

2: based on total N

 


Toxicity to activated sludge

Substance

Sludge

source/type

Process

Criterion

Value

product

[mg/L]

Value

 

[mg as/L]

Kontakt 320 SC

municipal seawage treatment plant

BOD

EC50

5115

1627

 

 

 

EC80

> 10000

> 3180

 

Endpoints Metamitron and Ethofumesaat.

For the use in beets, beetroots and tagetesTagetes also several tank mixes are applied for. For the use in Tagetes, Kontakt is only applied for as a tank mix in combination with metamitron. Therefore, combination effects are assessed for each aspect for the use in tagetes.Tagetes. For other tankmixes, only aquatic combination toxicity is considered (decision of the Board, 25-07-2005).

Metamitron is an old substance, not yet placed on Annex I of Directive 91/414/EEC. No DAR is available. For the risk assessment the most recent endpoints are used (C156.3.10, 04/2005). Ethofumesaat is an old substance, placed on Annex I of Directive 91/414/EEC. For the combination toxicology in water, relevant endpoints are taken from the most recent list of endpoints (05/2002). Considering the low toxicity of mineral oil for aquatic organisms, combination toxicology will not be taken into account for this substance.

 

 

endpoints

Metamitron

Ethofumesaat

Mineral oil*

Alga

EC50  (mg/L)

0.2

3.9

 

Daphnia

LC50   (mg/L)

>100

14

>1000

 

NOEC  (mg/L)

18

0.32

 

Fish

LC50   (mg/L)

440

11

>1000

 

NOEC (mg/L)

10

0.8

1

 

BCF/Pow

Log Pow = -0.17

144

 

Lemna

LC50  (mg/L)

-

>50

 

Sediment organism

EC50 (mg/L)

-

>5.0

 

Birds

LD50  (mg/kg bw)

900

 

 

 

LC50  (mg/kg)

>5000

 

 

 

NOEC (mg/kg)

1000

 

 

Mammals

LD50  (mg/kg bw)

2000

 

 

 

NOEC (mg/kg)

50

 

 

Bees

LD50 contact (µg/bee)

>100

 

 

 

LD50 oraal     (µg/bee)

>111

 

 

Non target -arthropods

LC50 T. pyri (kg a.s./ha)

>4.5

 

 

 

LC50 A. rhopalosiphi (kg a.s./ha)

>4.5

 

 

 

Aleochara bilineata

0% at 2.8 kg a.s./ha

 

 

 

Coccinella septempunctata

32% (non significant) on reproduction at 3.5 kg a.s./ha, 0% mortality

 

 

 

Pardosa spp

0% at 3.5 kg a.s./ha

 

 

Earthworms

LC50 (mg/kg)

914

 

 

 

NOEC (mg/kg)

21

 

 

Microorganisms

No effects > 25% after 28 days at

24 mg/kg

 

 

*Considering the low toxicity, combination toxicology is not calculated for mineral oil

 


7.1       Effects on birds

Birds can be exposed to the active substance phenmedipham by natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.

 

7.1.1    Natural food and drinking water

The threshold value for birds is based on the trigger from the BUBG. The threshold value for acute and short term exposure is set to 0.1 times the LD50 en LC50 value, and the threshold value for chronic exposure is set to 0.2 times the NOEC. In Table E.1 an overview of toxicity data and resulting threshold values are presented.

In the risk assessment a small bird with a body weight (BW) of 10 gram, a daily food intake (DFI) of 2.9 g/day and a daily water intake (DWI) van 3 g is chosen as representative target species. 

 

Table E.1 Overview of threshold values for birds

Test substance

Exposure

 

Endpoint

Safety factor

Threshold value

 

 

 

[mg/kg bw]

 

[mg/bird]

Phenmedipham

Acute

LD50 

>2500

10

>2.5

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Short term

LC50

>2000

10

>200

 

Long term

NOEC   

1200

5

240

 

 

 

 

 

 

 

 

 

[mg/kg bw]

 

[mg/bird]

Metamitron

Acute

LD50 

900

10

0.9

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Short term

LC50

>5200

10

>520

 

Long term

NOEC   

1000

5

200

 

The initial concentration in food is calculated using the relationship of Luttik et al. for leafs, leafy crops, fodder crop and small seeds and insects as 25 * application rate* number of applications. In first instance, acute, short term and long term exposure is examined against theworst-case PIECfood (in beets and tagetes (tank mix)),PIECfood, without taking decline of the residue between applications into account.

Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In first instance, acute exposure is compared to the PIECwater.

In Table E.2 an overview is presented of the calculated concentrations of the active substance phenmedipham in food.

 

Table E.2 Overview of concentrations in food in worst-case assessment

Use

Substance

Rate

RUD *

Max. freq.

PIECfood

 

 

[kg a.s./ha]

 

 

[mg/kg]

Beets

Phenmedipham

0.96

25

2

48

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

0.96

25

1

24

Tagetes

Phenmedipham

Metamitron

0.64

1.4

25

2

32

70

Tagetes

Phenmedipham

Metamitron

0.64

1.4

25

1

16

35

* residue per unit dose according to Luttik

 

In Table E.3, threshold exceeding factors at exposure to food and drinking water are presented.

 

Table E.3 Threshold exceeding factors for natural food and drinking water in worst-case assessment

Use

Substance

Threshold exceeding factors

 

 

water, acute

food, acute

food, short term

food, long term

 

 

PIEC*DWI/ 0.1*LD50target species

PIEC*DFI/ 0.1*LD50target species

PIEC/ 0.1*LC50

PIEC/ 0.2*NOEC

Beets

Phenmedipham

<0.001

<0.056

0.24

0.20

Tagetes

Phenmedipham

Metamitron

<0.001

<0.001

<0.37

0.23

0.16

<0.077

0.13

0.35

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

<0.001

<0.028

0.12

0.10

Tagetes

Phenmedipham

Metamitron

<0.001

<0.001

<0.19

0.12

0.08

<0.039

0.07

0.18

combination

<0.002

<0.60

0.24

0.48

combination

<0.002

<0.31

0.12

0.25

 

Taking the results in Table E.3 into account, a low risk for birds can be expected due to foraging and drinking of surface water for the worst-case uses in beets and the tank mix in tagetes. All other applications have lower risks.all proposed applications.

 

Therefore all proposed uses meet the standards laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

 

7.1.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms. Examination takes place against the chronic threshold value for birds of 0.2 * NOEC = 200240 mg/kg food.

 

Fish

For phenmedipham a BCF of 165 L/kg is available.

 

The highest PECwater(28)  (taken from paragraph 6.2.1.) is reached at the use in beets(aircraft treatment) and amounts 22.810.072 mg/L = 0.0230.000072 mg/L. 

The risk is then calculated as PECwater(28)  * BCFfish / trigger value = 0.0230.000036 * 165 / 240= 0.016.<0.001. Since this is below 1, the risk for birds as a result of consumption of contaminated/exposed fish is considered to be small.

 

Earthworms

Since there are no experimental data the bioconcentration factor for earthworms (BCFworm) is calculated according to the HTB (v0.2).

The logKow of phenmedipham is 3.59, which leads to a BCFworm = 7.18 kg soil/kg worm.

The highest PECsoil(28) is reached at the use in beets and amounts, corrected to the soil wet weight, 0.330.70 mg/kg soil. 

The risk is then calculated as PECsoil(28)  * BCFworm / trigger value = 0.330.70 * 7.18 / 240 = 0.010.0.021. Since this is below 1, the risk for birds as a result of consumption of contaminated/exposed worms is considered to be small.

 

Tank mix

The use in Tagetes is applied only as a tank mix with metamitron. Since the log Pow of metamitron is –0.17 and therefore < 3, no additional risk for secondary poisoning due to metamitron is expected.

 

Hence, the proposed uses meet the standards for secondary poisoning as laid down in the BUBG.

 

Conclusions birds

The proposed application of the product complies with the Regulation of Uniform Principles for Plant protection products (BUBG).

 

7.2       Effects on aquatic organisms

 

7.2.1    Aquatic organisms

The threshold values based on toxicity data for aquatic organisms are presented in Table E.4 for the active substance phenmedipham and metabolite MHPC. Threshold values for acute exposure are 0.01 times the lowest L(E)C50-value (daphnids and fish) and 0.1 times the lowest EC50-value for algae. Because the application for authorisation concerns an herbicide, also the effects on macrophytes (aquatic plants) are evaluated against the acute threshold value (0.1 times the lowest EC50).

 

Threshold values for chronic exposure are 0.1 times the lowest NOEC-value for daphnids and fish. See Table E.6 for the derivation of acute and chronic threshold values.

 

Table E.4 Overview toxicity endpoints and threshold values for the active substance phenmedipham and metabolite MHPC

Substance

Organism

Lowest

Safety factor

Threshold value

 

 

L(E)C50 [mg/L]

NOEC

[mg/L]

 

[mg/L]

[mg/L]

 

 

L(E)C50 [mg/L]

NOEC

[mg/L]

 

[mg a.s /L]

[mg a.s /L]

Phenmedipham

Acute

 

 

 

 

 

 

Algae

0.086

 

  10

0.0086

8.6

 

Daphnids

0.41

 

100

0.0041

4.1

 

Fish

1.71

 

100

0.0171

17.1

 

Macrophytes

0.23

 

  10

0.023

23

 

Chronic

 

 

 

 

 

 

Daphnids

 

0.061

10

0.0061

6.1

 

Fish

 

0.32

10

0.032

32

MHPC

Acute

 

 

 

 

 

 

Algae

30

 

  10

3.0

3000

 

Daphnids

14

 

100

0.14

140

 

Fish

75

 

100

0.75

750

Kontakt 320 SC

Acute

 

 

 

 

 

 

Algae

0.82

 

  10

0.082

82

 

Chronic

 

 

 

 

 

 

Daphnid

 

0.0229

10

0.00229

2.29

 

Fish

 

0.823

10

0.0823

82.3

Metamitron

Acute

 

 

 

 

 

 

Algae

0.2

 

  10

0.02

20

 

Daphnids

>100

 

100

>1

>1000

 

Fish

440

 

100

4.4

4400

 

Macrophytes

-

 

  10

-

-

 

Chronic

 

 

 

 

 

 

Daphnids

 

18

10

1.8

1800

 

Fish

 

10

10

1.0

1000

Ethofumesaat

Acute

 

 

 

 

 

 

Algae

3.9

 

  10

0.39

390

 

Daphnids

14

 

100

0.14

140

 

Fish

11

 

100

0.11

110

 

Macrophytes

>50

 

  10

>5

>5000

 

Chronic

 

 

 

 

 

 

Daphnids

 

0.32

10

0.032

32

 

Fish

 

0.8

10

0.080

80

 

The risk for aquatic organisms at the proposed uses of the active substance phenmedipham is assessed by comparing calculated surface water exposure concentrations (from section 6.2) with the trigger values mentioned above. In Table E.5a it is indicated if and to what extent exceeding of the threshold values for aquatic organisms occurs.

 

Table E.5a Threshold exceeding factors for active substance phenmedipham and metabolite MHPC

Use

Substance

PIEC*/

(0.1*EC50)

PIEC*/

(0.01*LC50)

PIEC*/

(0.01*LC50)

PIEC*/

(0.1*EC50)

PEC21*/

(0.1*NOEC)

PEC28*/

(0.1*NOEC)

 

 

Algae

Daphnid

Fish

Lemna

Daphnid

Fish

Beets

Phenmedipham

MHPC

0.53

0.0011

1.11

0.024

0.27

0.0045

0.20

0.031

 

0.0044

 

Beets, beetroots, strawberries, tree nurseries, flowerseeds, iris

Phenmedipham

MHPC

0.27

<0.001

0.56

0.007

0.13

0.0012

0.10

0.008

0.0012

Kontakt 320 SC

0.056

 

 

 

0.083

0.0023

Beets (aircraft application)

Phenmedipham

MHPC

2.65

0.0056

5.56

0.12

1.33

0.022

0.99

0.15

 

0.023

 

Kontakt 320 SC

0.027

 

 

 

0.021

0.0006

Tagetes

Phenmedipham

MHPC

Metamitron

0.18

<0.001

0.33

0.37

0.0042

<0.0033

0.09

0.0008

0.0008

0.048

0.0052

 

0.0015

0.00075

 

0.0025

Kontakt 320 SC

0.28

 

 

 

0.42

0.012

Beetroots, strawberries, tree nurseries, flowerseeds, iris

Phenmedipham

MHPC

0.53

<0.001

1.11

0.013

0.26

0.0023

0.20

0.016

0.0023

Kontakt 320 SC

0.056

 

 

 

0.042

0.0012

Tagetes

Phenmedipham

MHPC

Metamitron

0.35

<0.001

0.62

0.74

0.016

<0.012

0.18

0.0029

0.0028

0.13

0.021

 

0.0056

0.0030

 

0.0092

Kontakt 320 SC

0.037

 

 

 

0.057

0.0016

Kontakt 320 SC

0.019

 

 

 

0.014

<0.001

 

Combination*

0.97

0.75

0.18

0.13

0.063

0.012

 

Combination*

0.51

0.37

0.091

0.048

0.016

0.0035

*Combination: metamitron + highest value of Phenmedipham or Kontakt 320 SC

 

Taking the results in Table E.5 into account, it appears that for theactive substance phenmedipham the proposed uses in beets, beetroots, strawberries, tree nurseries, flowerseeds and iris a risk cannot be excluded. Therefore, an adequate risk assessment (e.g., higher tier studies) should be provided.a low risk is expected for aquatic organisms.

For the tank-mix use in tagetes, a low risk is expected.

 

Additional tankmixes

For beets and beetroots several possible tank mixes are given in the instructions for use. By a decision of the board, the combination of aquatic toxicity should be assessed for tank mixes. No aircraft application has been taken into account since these applications will exceed the threshold extensively. Since the risk for metabolite MHPC is lower than the risk for phenmedipham, the metabolite is not considered in these tank mixes. An overview of the threshold exceeding levels is given in Table. E.5b.

 

Table E.5b Threshold exceeding factors for tankmix** with active substance phenmedipham, metamitron and ethofumesaat

Use

Substance

PIEC*/

(0.1* EC50)

PIEC*/

(0.01*LC50)

PIEC*/

(0.01*LC50)

PIEC*/

(0.1* EC50)

PEC21*/

(0.1*NOEC)

PEC28*/

(0.1*NOEC)

Use**

Substance

PIEC*/

(0.1* EC50)

PIEC*/

(0.01*LC50)

PIEC*/

(0.01*LC50)

PIEC*/

(0.1* EC50)

PEC21*/

(0.1*NOEC)

PEC28*/

(0.1*NOEC)

 

 

Algae

Daphnid

Fish

Lemna

Daphnid

Fish

Beets (a)

Phenmedipham

Metamitron

0.53

0.62

1.11

<0.012

0.27

0.0028

0.20

0.031

0.0056

0.0044

0.0092

Beets (a)

Phenmedipham

Metamitron

0.27

0.25

0.56

<0.05

0.13

0.0011

0.10

0.008

0.0022

0.0012

0.0038

Kontakt 320 SC

0.056

 

 

 

0.083

0.0023

Kontakt 320 SC

0.027

 

 

 

0.021

0.0006

 

Combination*

1.15

1.11

0.27

 

0.089

0.013

 

Combination*

0.52

0.61

0.13

 

0.023

0.0050

Beets (b)

Phenmedipham

Metamitron

0.53

0.50

1.11

<0.099

0.26

0.0023

0.20

0.016

0.0045

0.0023

0.0075

Kontakt 320 SC

0.056

 

 

 

0.042

0.0012

 

Combination*

1.15

1.11

0.26

 

0.047

0.0098

Beets (c)

Phenmedipham

Metamitron

Ethofumesaat

0.088

0.17

0.0024

0.19

<0.002

0.0068

0.044

<0.001

0.0086

0.033

 

<0.002

0.0026

0.0015

0.027

<0.001

0.0025

0.010

Kontakt 320 SC

0.0093

 

 

 

0.0070

<0.001

 

Combination*

0.26

0.20

0.054

0.035

0.036

0.014

Beetroots

Phenmedipham

Metamitron

0.27

0.50

0.55

<0.099

0.13

0.0023

0.099

0.0078

0.0045

0.0011

0.0075

Kontakt 320 SC

0.028

 

 

 

0.022

<0.001

 

Combination*

0.77

0.65

0.13

0.099

0.027

0.0086

Beets (b)

Phenmedipham

Metamitron

Ethofumesaat

0.044

0.09

0.0012

0.10

<0.001

0.0034

0.022

<0.001

0.0043

0.017

 

<0.001

0.0013

0.0008

0.014

<0.001

0.0013

0.005

Kontakt 320 SC

0.0046

 

 

 

0.0035

<0.001

 

Combination*

0.14

0.10

0.027

0.018

0.018

0.0073

*Combination: metamitron ( + ethofumesaat) + highest value of Phenmedipham or Kontakt 320 SC

 

**Tank mixes:

Beets:

(a)2 x   0.96 kg phenmedipham+ 1.4 kg metamitron/ ha  (interval 7 days)  or

(b) 0.48 -0.96 kg phenmedipham + 2.1 kg metamitron/ha                   or

(c)(b) 0.080-0.16 kg phenmedipham + 0.35 –0.70 kg metamitron + 0.10-0.20 g ethofumesaat

Beetroots:

0.48 kg phenmedipham + 2.1 kg metamitron/ha

 

For the tank mix in beets with metamitron and ethofumesaat, and the tank mix in beetroots with metamitronall proposed tank mixes a low risk for aquatic organisms is expected.

 

Therefore the tank mix uses in tagetes, beets (with ethofumesaat and metamitron) and beetroots meet the standards for toxicity to aquatic organisms as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG). The other applications and tank mixes in beets, beetroots, strawberries, tree nurseries, flower seeds and iris does not meet the standards for toxicity to aquatic organisms as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG). Therefore, an adequate risk assessment (e.g., higher tier studies) should be provided for these applications.all proposed uses meet the standards for toxicity to aquatic organisms as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

 

7.2.2    Risk assessment for bioconcentration

For the active substance a BCF-value of 165 L/kg is available.

 

Since the BCF is above 100 L/kg and the substance phenmedipham is not ready biodegradable, there is a risk for bioconcentration.

According to the guidance document on aquatic ecotoxicology the following points should be checked:

1)      Direct long-term effects in fish due to bioconcentration;

2)      Secondary poisoning for birds and mammals;

3)      Biomagnification in aquatic food chains

Ad 1) An ELS study should be available if 100 < BCF < 1000 and EC50 a.s. < 0.1 mg/L. A FLS should be available if BCF > 1000. These triggers are not exceeded for phenmedipham.

Ad 2) From the assessments of birds and mammals appear that there is no risk on secondary poisoning.

Ad 3) TheOnly required if the BCF > 1000 and the elimination in the BCF study within 14 days < 95% and the DT90 water > 100 days). These triggers are not exceeded for phenmedipham.

 

These triggers are not exceeded. Hence, the active substance phenmedipham meets the standards for bioconcentration as laid down in the BUBG.

 

7.2.3    Risk assessment for sediment organisms

Since the NOEC for daphnids is below 0.1 mg/L and the water–sediment study indicates that over 10% of the a.s. phenmedipham is found in the sediment after 14 days, there is a potential risk for sediment organisms.

 

The threshold value for Chironomus is 0.1 x NOEC = 37 µg/L. When this value is examined against the worst-case PIEC in water for theaircraft use in beets of 22.812.28 µg/L, the threshold exceeding level amounts 0.62.0.061. Metabolite MHPC is also formed in a relevant amount in the sediment but because of the low toxicity to aquatic organisms (LC50 daphnia = 14 mg/L), a low risk to sediment organisms is expected.

For metamitron the NOEC for Daphnida is 18 mg/L therefore, a low risk is expected for sediment organisms. For ethofumesaat a NOEC of   5 mg/L is available. The threshold value for Chironomus is 0.1 x NOEC = 500 µg/L. When this value is examined against the PIEC in water of 0.950.48 µg/L, the threshold exceeding level amounts = 0.0019.0.00096.

Therefore, the active substance phenmedipham and metabolite MHPC and the combinations with metamitron and ethofumesaat meet the standards for sediment organisms as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

 

Conclusions aquatic organisms

The proposed applications of the product do not complycomplies with the Regulation of Uniform Principles for Plant protection products (BUBG). The acute toxicity of phenmedipham for algae and Daphnid exceeds the threshold level.

 

7.3       Effects on terrestrial vertebrates other than birds

Mammals can be exposed to the active substance phenmedipham by natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.

 


7.3.1    Natural food and drinking water

The threshold value for mammals is based on the trigger from the BUBG. The threshold value for acute exposure is set to 0.1 times the LD50 value, and the threshold value for chronic exposure is set to 0.2 times the NOEC. In Table E.6 an overview of toxicity data and resulting threshold values are presented.

In the risk assessment a small mammal with a body weight (BW) of 6 gram (i.e., a mouse), a daily food intake (DFI) of 1.025 g/day and a daily water intake (DWI) vanof 1.8 g is chosen

 

Table E.6 Overview of threshold values for mammals

Substance

Exposure

 

Endpoint

Safety factor

Threshold value

 

 

 

[mg/kg bw]

 

[mg/mammal]

Phenmedipham

Acute

LD50 

>320

10

0.192

Phenmedipham

Acute

LD50 

>320

10

0.192

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Long term

NOEC   

100

5

20

 

 

 

[mg/kg bw]

 

[mg/mammal]

Metamitron

Acute

LD50 

2000

10

1.2

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Long term

NOEC   

50

5

10

 

The initial concentration in food is calculated using the relationship of Luttik et al. for leafs, leafy crops, fodder crop and small seeds and insects as 25 * application rate* number of applications. In first instance, acute and long term exposure is examined against the PIECfood (in beets and tagetes (tank mix)), without taking decline of the residue between applications into account.

Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In first instance, acute exposure is compared to the PIECwater.

 

In Table E.7 an overview is presented of theworst-case calculated concentrations of the active substance phenmedipham in food.

 

Table E.7 Overview worst-case concentrations in food

Use

Substance

Rate

RUD *

Max. freq.

PIECfood

 

 

[kg a.s./ha]

 

 

[mg/kg]

Beets

Phenmedipham

0.96

25

2

48

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

0.96

25

1

24

Tagetes

Phenmedipham

Metamitron

0.64

1.4

25

2

32

70

Tagetes

Phenmedipham

Metamitron

0.64

1.4

25

1

16

35

* residue per unit dose according to Luttik

 

In Table E.8, threshold exceeding factors at exposure to food and drinking water are presented.

 


Table E.8 Threshold exceeding factors for natural food and drinking water

Use

Substance

Threshold exceeding factors

 

 

water, acute

food, acute

food, long term

 

 

PIEC*DWI/ 0.1*LD50target species

PIEC*DFI/ 0.1*LD50target species

PIEC/ 0.2*NOEC

Beets

Phenmedipham

<0.001

0.21

2.4

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

<0.001

0.11

1.2

Tagetes

Phenmedipham

Metamitron

<0.001

<0.001

0.17

0.060

1.6

7.0

Tagetes

Phenmedipham

Metamitron

<0.001

<0.001

0.09

0.030

0.8

3.5

 

Combination

<0.001

0.23

8.6

 

Combination

<0.002

0.12

4.3

 

Taking the results in Table E.8 into account, it appears that a low acute risk for mammals can be expected due to foraging (acute) and drinking of surface water for all proposed uses. However, there is a potential long-term risk to foraging for all proposed applications.

 

Since the long-term exposure is larger than the threshold value, a refinement of the risk assessment is carried out, taking residue decline on the crop in between applications into account. Since the half-life of the formulation on plant material is unknown, a default DT50 value of 10 days is used as a first approach. For metamitron, the DT50 is < 2 days (See also C-156.3.10, 04/2005).In determining the PIECfood a MAF (Multiple Application Factor) is applied. The PECfood, long is calculated as time-weighted average over a period of 28 days. See Table E.9 for results.

 

Table E.9 Overview of concentrations in food, taking residue decline on the crop into account

Use

Substance

Rate

RUD *

Max. freq.

interval

MAF

PECfood,

ftwa

Use

Substance

Rate

RUD *

Max. freq.

interval

PECfood,

ftwa

 

 

[kg/ha]

 

 

 

 

[mg/kg]

 

 

[kg/ha]

 

 

 

[mg/kg]

Beets

Phenmedipham

0.96

25

2

7

1.7

18

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

0.96

25

1

-

10.6

Tagetes

Phenmedipham

Metamitron**

0.64

1.4

25

2

7

1.7

1.3**

12

4.7

Tagetes

Phenmedipham

Metamitron**

0.64

1.4

25

1

-

7.06

3.61

* residue per unit dose according to Luttik

**DT50 metamitron < 2 days

 

In Table E.10, threshold exceeding factors at exposure to food taking residue decline in account are presented.

 

Table E.10 Threshold exceeding factors for natural food, taking residue decline on the crop into account

Use

Substance

Threshold exceeding factors

 

 

food, long term

 

 

PECfood, long / 0.2*NOEC

Beets

Phenmedipham

0.90

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

0.53

Tagetes

Phenmedipham

Metamitron

0.60

0.47

Tagetes

Phenmedipham

Metamitron

0.35

0.36

 

Combination

1.07

 

Combination

0.71

 

Taking the results in Table E.10 into account, it appears that a low risk is expectedfor the worst-case use in beets on phenmedipham only. All other uses have lower risks to phenmedipham. In tagetes, in combination with metamitron the threshold exceeding level is exceeded. In the risk assessment however is assumed that mammals are eating only treated food for the total exposure period. Since this is highly unlikely it is to be expected that the long-term risk for mammals will be < 1.

all proposed uses. All proposed uses meet the standards laid down in the BUBG.

 

7.3.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms. The examination takes place against the chronic threshold value for mammals of 0.2 * NOEC = 20 mg/kg food.

 

Fish

For phenmedipham a BCF of 165 L/kg is available.

 

The highest PECwater(28)  (taken from paragraph 6.2.1.) is reached at the use in beets(aircraft treatment) and amounts 22.810.036 mg/L = 0.0230.000036 mg/L. 

The risk is then calculated as PECwater(28)  * BCFfish / trigger value = 0.0230.000036 * 165 / 20 = 0.19.<0.001. Since this is below 1, the risk for mammals as a result of consumption of contaminated/exposed fish is considered to be small.

 

Earthworms

Since there are no experimental data the bioconcentration factor for earthworms (BCFworm) is calculated according to the HTB (v0.2).

The logKow of phenmedipham is 3.59, which leads to a BCFworm = 7.18 kg soil/kg worm.

The highest PECsoil(28) is reached at the use in beets and amounts, corrected to the soil wet weight, 0.330.70 mg/kg soil. 

The risk is then calculated as PECsoil(28)  * BCFworm / trigger value = 0.330.70 * 7.18 / 20 = 0.11.0.25. Since this is below 1, the risk for mammals as a result of consumption of contaminated/exposed worms is considered to be small.

 

Tank mix

The use in Tagetes is applied only as a tank mix with metamitron. Since the log Pow of metamitron is –0.17 and therefore < 3, no additional risk for secondary poisoning due to metamitron is expected.

 

Hence, the proposed uses meet the standards for secondary poisoning as laid down in the BUBG.

 

Conclusions mammals

The proposed application of the product complies with the Regulation of Uniform Principles for Plant protection products (BUBG)

 

 

7.4       Effects on bees

The risk assessment for bees and bumblebees is based on the ratio between the single application rate and toxicity endpoint (LD50 value). An overview of the riskat the worst-case use in beets and tagetes (tank mix) is given in Table E.11.

 


Table E.11 Risk for bees and bumblebees

Use

Substance

Application rate a.s.

LD50

 

Rate/LD50

 

 

[g/ha]

[µg/bee]

 

Beets

Phenmedipham

960

50

19.2

(Sugar)beets, beetroots, strawberries, tree nurseries, flower seeds, iris

Phenmedipham

960

50

19.2

Tagetes

Phenmedipham

Metamitron

640

1400

50

>100

12.8

14

 

Combination

 

 

17

 

Combination

 

 

27

 

Since theworst-case ratio rate/LD50 is below 50, the risk for bees is considered to be low.The other proposed uses have lower risks. Hence, all proposed uses meet the standards for bees and bumblebees as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

 

Conclusions bees

The product complies with the Regulation of Uniform Principles for Plant protection products (BUBG).

 

7.5       Effects on any other organisms (see annex IIIA 10.5-10.8)

 

7.5.1        Effects on non-target arthropods

 

standardStandard species: Thyphlodromus pyri

The risk for non-target arthropods is assessed by calculating Hazard Quotients. To enable this, Lethal Rate values (LR50) are needed. Based on LR50-values from studies with the two standard species Aphidius rhopalosiphi (not available) and Typhlodromus pyri (LR50 > 0.960 kg/ha) an in-field and an off-field Hazard Quotient (HQ) can be calculated according to the (new) assessment method established in the SETAC/ESCORT 2 workshop and described in the HTB (v 0.2). Hazard Quotients should be below the trigger value of 2 to meet the standards. Resulting Hazard Quotients are presented in Table E.12.

 

Table E.12 HQ-values for and T. pyri 

 

Application rate

(kg a.s./ha)

MAF1

Drift factor/

Vegetation factor2

Safety

factor2

LR50

(kg a.s./ha)

HQ

In-field

 

 

 

 

 

 

T. pyri

0.960

1.7

-

-

>0.960

<1.7

T. pyri

0.960

1

-

-

>0.960

<1.0

Off-field

 

 

 

 

 

 

T. pyri

0.960

1.7

0.01

10

>0.960

<0.17

T. pyri

0.960

1

0.01

10

>0.960

<0.10

1: Multiple Application Factor

2: off-field: drift factor = 10%, vegetation dilution factor = 10, safety factor = 10 (default values)

 

As can be seen in table E.12,From the above table, it reads that both worst-case in- and off-field HQ valuesfor T. are below the trigger value of 2. The other applications have lower dose rates and thus lower risks.

Therefore, a low risk is expected for T. pyri for all uses.

 

standardStandard species: Aphidius rhopalosiphi

In principle data are required regarding adverse side effects of the formulation Kontakt on two standard species (Aphidius rhopalosiphi and Typhlodromus pyri)and two species relevant to the proposed use. The risk assessment for T. pyri has been described in the section above. The trigger value for first tier laboratory tests is 30 % adverse effects. For extended laboratory tests the trigger value is 50 %.

 

In a standard laboratory testwith the formulation Kontakt 320 SC, 78.6% mortality was found at a dose of 0.96 kg a.s./ha. Therefore extended laboratory tests have been submitted. At a dose of 0.038 kg a.s./ha corrected mortality was 13.3%, while reproduction was decreased with 60%. Since several controls did not fulfil the validity criteria, an additional study was performed. In this study corrected mortality was 14% at a dose rate of 0.102 kg a.s./ha, while reproduction was adversely affected with 31%. In this study also some of the controls did not fulfil the validity criteria. An extended laboratory study with a different formulation (Kemifam Flow,

160 g/l), showed no mortality, but a decreased reproduction of 35% at 0.96 kg fenmedifam/ha.

Since it is unclear why the first two studies differ in outcome and the highest tested rates in all studies, is lower than the applied rates (2 x 0.64 - 2 x 0.96 kg a.s./ha), a risk for A. rhopalosiphi cannot be excluded. An adequate risk assessment (i.e. aged residue or (semi)-field studies) is required.In a new extended laboratory study, no effects on mortality and reproduction were found at an application rate of 0.96 kg a.s./ha. In this study no mortality in the control was found and the mean number of mummies per female was high (>50). This study seems to be more reliable than the previous studies.

Since no adverse effects on mortality and reproduction were found at 0.96 kg a.s./ha, which is equal to or higher than all the proposed dose rates, a low infield and off-field risk is expected for A. rhopalisiphi.

 

Other arthropods: Chrysoperla carnea, Pardosa sp., Aleochara bilineata and Poecilus cupreus

In standard laboratory tests no adverse effects on mortality or sublethal parameters (reproduction, consumption) > 30% were found at a dose of 0.96 kg a.s./ha. This dose is equal to or higher than the single application rate of beets and tagetes and the application rates in strawberries, tree nurseries, flowerseeds and iris. Forall proposed application rates. Therefore a low risk is expected for non-target arthropods is expected for all proposed uses, based these uses no risks are expected. For the multiple applications in beets and tagetes, unacceptable effects cannot be ruled out. For these applications tests with relevant doses are required.on the formulation Kontakt only.

 

Risk assessment Tank mix Tagetes

For metamitron LC50 values of > 4.5 kg a.s./ha are available for the standard species T. pyri and A. rhopalosiphi. Since An LC50 value for the formulation Kontakt is available for T. pyri, it is possible to assess the combined effects. This is shown in table E.13.

 

Table E.13 HQ-values for and T. pyri  (first tier assessment)

 

Substance

Application rate

(kg a.s./ha)

MAF1

Drift factor/

Vegetation factor2

Safety

factor2

LR50

(kg a.s./ha)

HQ

In-field

 

 

 

 

 

 

 

T. pyri

Phenmedipham

0.64

1.7

-

-

>0.960

<1.13

T. pyri

Phenmedipham

0.64

1

-

-

>0.960

<0.67

 

Metamitron

1.4

1.33

-

 

>4.5

<0.40

 

Metamitron