Toelatingsnummer 12521 N

 

TRAMAT 500  

 

12521 N

 

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

BESTRIJDINGSMIDDELEN

 

1 HERREGISTRATIE  EN WIJZIGING TOELATING

 

Gelet op de aanvraag d.d. 26 januari 2005 (20050030 THG) van

 

Bayer CropScience B.V.

Energieweg 1

3641 RT  MIJDRECHT

 

 

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

 

TRAMAT 500

 

gelet op de artikelen 3, 4 en 5 van de Bestrijdingsmiddelenwet 1962,

 

BESLUIT HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN als volgt:

 

1.      De toelating van het bestrijdingsmiddel TRMAT 500 in de zin van artikel 2, eerste lid, van de Bestrij­dings­middelen­wet 1962, wordt gewijzigd. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II dezes.

2.      De toelating van het bestrijdingsmiddel TRAMAT 500, welke expireert op 1 maart 2007 wordt verlengd 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.

3.      De toelating geldt tot 28 februari 2013.

 

§ 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:

-    Gehalte:

 

 

Ethofumesaat

500 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): 1,2-benzisothiazool-3-on

 

 

  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:

 

 

N

Milieugevaarlijk

 

 

-          Waarschuwingszinnen:

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

 

-          Veiligheidsaanbevelingen:

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.   bij het toelatingsnummer een cirkel met daarin de aanduiding W.1

 

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. 

 

§ V Aflever- en/of opgebruiktermijn

Op grond van artikel 2, vijfde lid van de Bestrijdingsmiddelenwet 1962 mag het middel Agrichem ethofumesaat (2) in niet conform dit besluit gewijzigde verpakkingen:

1.      voor de periode van 1 maart 2007 tot 1 maart 2008 nog worden gebruikt en ten behoeve van het gebruik voorhanden of in voorraad worden gehouden;

2.      voor de periode van 1 maart 2007 tot 1 maart 2008 nog worden verkocht, te koop of te ruil worden aangeboden, ter beschikking worden gesteld, worden geschonken alsmede worden uitgedeeld.

 

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

Het betreft een aanvraag tot herregistratie van de toelating van het middel TRAMAT 500 (12521 N), een middel op basis van de werkzame stof(fen) ethofumesaat. De herregistratie wordt aangevraagd voor de toelating als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten.

 

2.2 Wijziging toelating

De wijziging betreft het opnemen van de volgende restricties in het Wettelijk Gebruiksvoorschrift en Gebruiksaanwijzing (WGGA):

­        Ethofumesaat mag slechts om de 3 jaar worden toegepast. De totale dosering in één seizoen mag niet groter zijn dan 1,0 kg ethofumesaat per hectare

De volgende restrictie in het WGGA komt te vervallen

­        Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling

 

Op grond van het Besluit CTB Herregistratieprocedure van 12 januari 2005 wordt bij intrekking/wijziging van de toelating een aflever- en opgebruiktermijn vastgesteld van
12 maanden.

 

2.3 Informatie met betrekking tot de stof

De werkzame stof ethofumesaat is bij Richtlijn 2002/37/EG, dd 3 mei 2002 van de Europese Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn 91/414/EEG.


 

2.4 Karakterisering van het middel

Tramat 500 is een herbicide op basis van ethofumesaat en de werkzame stof ethofumesaat is zowel sec toegelaten als in diverse combinaties met desmedifam, fenmedifam en metamitron. Ethofumesaat behoort tot de groep van benzofuran-verbindingen. Het werkingsmechanisme is gebaseerd op de remming van de vetzuursynthese, waardoor onder meer de vorming van een celmembraam wordt belemmerd. De groei van de meristemen wordt geremd en de celdeling vertraagd,. Deze stof heeft een systemische werking in de plant en wordt opgenomen door het blad. De opname door het blad (incl. opnamesnelheid) neemt af naarmate de onkruiden groter zijn. Ethofumesaat werkt op éénjarige grassen en éénjarige tweezaadlobbige onkruiden.

 

2.5 Voorgeschiedenis

De aanvraag is ingediend op 27 januari 2005, op 27 januari 2005 zijn de verschuldigde aanvraagkosten ontvangen. De aanvraag is op 1 juli 2005 in behandeling genomen. De verschuldigde beoordelingskosten zijn op 13 juli 2005 ontvangen. De aanvraag is op 13 september 2006 besproken in C-173.3.10, waarbij aanvullende gegevens gevraagd zijn voor de aspecten fysische en chemische eigenschappen en milieu. Op 8 december 2006 zijn deze gegevens ontvangen, en op 14 december 2006 zijn de gegevens in behandeling genomen. De verschuldigde beoordelingskosten werden 10 januari 2007 ontvangen.

 

 

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 TRAMAT 500 op basis van de werkzame stof(fen) ethofumesaat 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 februari 2007

 

 

HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN,





(voorzitter)

 

 



HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE I bij het besluit d.d. 23 februari 2007 tot herregistratie van het middel TRAMAT 500, toelatingnummer 12521 N

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten.

 

Ethofumesaat mag slechts om de 3  jaar worden toegepast.

De totale dosering in één seizoen mag niet groter zijn dan 1,0 kg ethofumesaat per hectare.

 

Het is verboden dit middel met een vliegtuig toe te passen.

 

Het middel is uitsluitend bestemd voor beroepsmatig gebruik.

 

 

 

B.

GEBRUIKSAANWIJZING

 

Algemeen
TRAMAT 500 is een bodemherbicide met systemische werking via de ondergrondse delen van de onkruiden. Met uitzondering van kamille bestrijdt TRAMAT 500 een breed spectrum éénjarige onkruiden waaronder kleefkruid.

 

Toepassing dient plaats te hebben op een vochtige grond in een periode dat regen wordt verwacht. Regenval na de toepassing komt de werking ten goede.

 

Het gelijktijdig verspuiten met insecticiden of fungiciden is niet verantwoord.

 

Waterhoeveelheid: 200-300 liter water per ha.

 

Altijd na TRAMAT 500 goed kerend ploegen alvorens opnieuw in te zaaien of te planten. Bij mislukken van een cultuurgewas waarin TRAMAT 500 werd toegepast kunnen de volgende gewassen na kerend ploegen gezaaid of geplant worden: suiker-en voederbieten, maïs, bruine bonen, tuinbonen, raaigrassen, witlof, erwten, spinazie, knolselderij, wortelen, zaai- en plantuien. In deze volggewassen dan geen TRAMAT 500 toepassen.

 

Gebruik geen onverstevigde pvc-slangen en filters fijner dan 0,3 mm. Bewaar TRAMAT 500 op een koele plaats en bescherm het tegen vorst.

 

Toepassingen

 

Suiker- en voederbieten

TRAMAT 500 is na opkomst alleen werkzaam in combinatie met fenmedifam. Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige zaadonkruiden.

Deze combinaties komen vooral in aanmerking voor toepassing op zand- en dalgronden en specifiek voor de bestrijding van veelknopigen en kleefkruid op alle grondsoorten.

Dosering

·         Vanaf het 2-bladstadium van de biet:

0,3 liter TRAMAT 500 + 2 liter fenmedifam in 200-250 liter water per ha.

Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,3 liter Tramat 500 + 2 liter fenmedifam.

Tijdelijk kan enige gewasbeschadiging optreden, vooral van kleine bietenplantjes. De eerste 2 echte blaadjes moeten daarom bij alle bieten min. 1 cm groot zijn alvorens een behandeling wordt uitgevoerd en de onderstaande restricties dienen opgevolgd te worden.

 

·         Vanaf het 4-bladstadium van de biet

Eenmalig 1 liter TRAMAT 500 + 5 liter fenmedifam in 250-300 liter water per ha.

 

Mengvoorschriften

TRAMAT 500 toegepast in combinatie met fenmedifam:

-          Giet 20-50 liter water in de tank.

-          Voeg fenmedifam toe en zet het roersysteem in werking.

-          Voeg water toe tot de helft van de benodigde hoeveelheid.

-          Voeg TRAMAT 500 toe.

-          Vul verder aan met water.

 

Laat de roerinrichting in werking, zowel bij het vullen van de tank als tijdens het spuiten.

 

Restricties:

-        Spuit alleen op een afgehard en gezond bietengewas, dat niet verzwakt is door insecten,
stuifschade, nachtvorst of herbiciden.

-        Spuit niet bij maximale dagtemperatuur boven 18°C en niet bij scherp zonnig weer. In deze gevallen bij voorkeur ‘s avonds spuiten.


HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE II   RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        4

 

2.   Physical and chemical properties                  5

 

3.   Methods of analysis                                         10

 

4.   Mammalian toxicology                                      12

 

5.   Residues                                                            17

 

6.   Environmental fate and behaviour                22

 

7.   Ecotoxicology                                                    37

 

8.   Efficacy                                                               57

 

9.   Conclusion                                                        58

 

10. Classification and labelling                             58

 


1.         Identity of the plant protection product

 

1.1       Applicant

Bayer Crop Science B.V.

Energieweg 1

Mijdrecht

 

 

1.2       Identity of the active substance

Common name

Ethofumesate

Name in Dutch

Ethofumesaat

Chemical name

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate

CAS nr

26225-79-6

EEC nr

247 525-3

 

The active substance was included in Annex 1 of Directive 91/414/EC on 1 March 2003.

 

 

1.3       Identity of the plant protection product

Name

Tramat 500

Formulation type

SC

Content active substance

500 g/L

 

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

 

 

1.4       Function

Herbicide

 

1.5       Uses applied for

Tramat 500 is proposed to control a broad spectrum of annual weed, amongst them cleavers. Tramat 500 has no efficacy against Scented mayweed.

 

Uses

Dose a.s.

(g a.s./ha)

Number of applications

Interval between applications

Application time (growth stage and season)

Sugar and fodder beet

150

2

10-14 days

Above BBCH 12 in May-June

Sugar and fodder beet

500

1

-

Above BBCH 14 in May-June

 

1.6       Background to the application

The apllication concerns a re-registration of an authorised formulation.

 

1.7       Packaging details

1.7.1    Packaging description

Material:

HDPE

Capacity:

0.25-10 L

Type of closure and size of opening:

Type: Injection moulded with induction sealing disc.

Size of opening: 50 mm (0.25-1 L) or 63 mm (3-10 L)

Other information

not applicable

 


 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.      Physical and chemical properties

 

2.1              Active substance: ethofumesate

Data about the identity and the physical and chemical properties are taken from the List of Endpoints (monograph, March2003). Changes and/or additions are taken up in italics.

 

Identity

Common name (ISO)

Ethofumesate

Chemical name (IUPAC)

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate

Chemical name (CA)

5-Benzofuranol, 2-ethoxy-2,3-dihydro-3,3-dimethyl-, methanesulfonate, (.+-.)-

CIPAC No

233

CAS No

26225-79-6

EEC No

247 525-3

FAO SPECIFICATION

Not available

Minimum purity

960 g/kg

Molecular formula

C13H18O5S

Molecular mass

286.3

Structural formula

 

 

 

Physical-chemical properties

Melting point (state purity)

69.6-70.7 °C (99.9 %)

Boiling point (state purity)

ethofumesate decomposes before reaching the boiling point

Temperature of decomposition

(DSC), 285 °C

(TGA),  224°C

Appearance (state purity)

white crystalline solid

Relative density (state purity)

1.3 (20 °C/96.9 %)

Surface tension

not applicable

Vapour pressure (in Pa, state temperature)

6.5 x 10-4 at 25 °C

 

Henry’s law constant (in Pa·m3·mol-1)

3.72 x 10-3 at 25 °C

6.8 x 10-4 at 25 °C (technical grade)

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

pH 3 -11: 39 - 44 mg/l (tech. material) at 20.0±0.5°C

pH 7.7: 50 mg/l at 25.0±0.5°C

pH 7.7: 57 mg/l at 30.0±0.5°C

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

acetone, dichloromethane, dimethylsulphoxide,

ethyl acetate > 600 g/l at 25°C

toluene and p-xylene 300-600 g/l at 25°C

methanol 120-150 g/l at 25°C

ethanol 60-75 g/l at 25°C

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

2.7 (pH 6.4 at 25 °C)

2.7 (pH 6.4 at 20 °C)

Hydrolytic stability (DT50) (state pH and temperature)

-pH 5 (35°C): 2.68% of NC 8493 were detected after 36 days. Half-life is 940 days.  Ethofumesate is stable to hydrolysis.

-pH 5 (25 °C): 1.57% of NC 8493 were detected after 36 days. Half-life is 2050 days. Ethofumesate is stable to hydrolysis.

-pH 7 (35°C and 36 days): stable to hydrolysis

-pH 9 (25°C and 36 days): stable to hydrolysis

Dissociation constant

according to the chemical structure ethofumesate is not expected to dissociate in water

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

e at 230 nm: 6650 

e at 282 nm: 2520 

e at 228 nm: 7090 

e at 282 nm: 2790 

Abs. max at 230 nm and 282 nm, with a tailing

of low absorbance between 290 and 300 nm.

Absorption of sunlight is only expected at a narrow range between 290 and 300 nm. No absorption > 300 nm.

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

8 - 13  d:      12 h of sunlight exposure per day

37 - 62 d:     during summer at 40°N to 60°N in Europe

 

4.6  d: whole year - central Europe

2.6 d: for month May

 

DT50 was calculated as 7 days and DT90 as 23 days assuming first order kinetics. (new study 2000)

Quantum yield of direct photo-

transformation in water at λ > 290 nm

9.5 – 11 x 10-5

Photochemical oxidative degradation in air

2.1 h             Atkinson

4.1 h             Atkinson

Flammability

Not flammable (method A10 and A12)

Auto-flammability

Not auto-flammable (method A16)

Does not self-ignite at RT (method A13)

Oxidative properties

Not oxidising (statement based on chemical structure)

Explosive properties

Not explosive (method A14)

 

 

2.2              Plant protection product: Tramat 500

Data about plant protection product are all based on reports of studies with Nortron 50 SC provided by the applicant with the application for renewal of the registration. The applicant stated that Nortron 50 SC is another trade name for Tramat 500.

 

The range of the application concentrations of the plant protection product is 0.12-0.4 %.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP: no

Method: visual

viscous liquid

acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP: no

Method: visual

beige to greyish

Munsell colour 2.5 Y 7/2

acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP: no

Method: olfactory

aromatic

acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP: yes

Method: EEC A.14

not sensitive to shock, not explosive when heated

acceptable

B.2.2.5 (IIIA 2.2)

Oxidizing properties

GLP: no

Method: expert statement

no oxidizing properties

acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

not applicable for a liquid

acceptable

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP: yes

Method: EEC A.15

auto-ignition temperature 475°C

acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP: yes

Method: EEC A.9

no flash point up to 100°C

acceptable

B.2.2.9 (IIIA 2.4)

Acidity/

alkalinity

 

not applicable (4£ pH £ 10)

acceptable

B.2.2.10 (IIIA 2.4)

pH

GLP: yes

Method: CIPAC MT 75.3

1% in double distilled water at 22.8°C: pH 7.3

acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP: yes

Method: EEC A.5

At 40°C, undiluted product:

41.7 mN/m

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OPPTS 830.1700

dynamic viscosity

shear rate

(s-1)

viscosity at 20°C

(mPa.s)

viscosity at 40°C

(mPa.s)

100

-

92

20

-

261

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OPPTS 830.1700, calculated from dynamic viscosity and density

kinematic viscosity

shear rate

(s-1)

viscosity at 20°C

(mm2.s-1)

viscosity at 40°C

(mm2.s-1)

100

-

82

20

-

233

acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP: yes

Method: OECD 109

1.13 g/cm3 at 20°C

acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

not relevant for a liquid

acceptable

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

Method: CIPAC MT 46

In 1 L HDPE bottle:

Physically and chemically stable for 14 days at 54°C. Pourability after storage was just outside acceptable limits (3.14% residue, 0.30% rinsed residue).

Acceptable, although suspensibility was determined at too high a concentration (0.4-2.0%) (see B.2.2.18).

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

Method: CIPAC MT 39

Stable for 7 days at 0°C.

Acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

GLP: no

Method: CLITM 17

In 1 L HDPE bottle:

Physically and chemically stable for two years at ambient temperature.

Acceptable, although suspensibility was determined at too high a concentration (0.4-2.0%) (see B.2.2.18).

B.2.2.16

(IIIA 2.8)

Wettability

 

not relevant for a liquid

acceptable

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP: no

Method: CIPAC MT 47.2

0.1%, CIPAC D water:

29/1 mL after 1/12 min.

1%, CIPAC D water:

8/0 mL after 1/12 min.

acceptable

B.2.2.18

(IIIA 2.8)

Suspensibility

GLP: no

Method: CIPAC MT 161

 

GLP:no

CIPAC MT184

At 30°C in CIPAC D water:

98% at 0.4%, 98% at 2.0%

 

 

 

Additional test at the lowest proposed concentration for use: 0.12% (0.3g in 250ml) in CIPAC D water: 99%

 

Suspensibility was not determined in CIPAC A water. Because suspensibility tests in CIPAC D water showed a very high suspensibility, there is sufficient reason to believe results will be acceptable in CIPAC A water as well.

Acceptable

 

 

 

 

Acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

GLP: no

Method: CIPAC MT 160

95% in CIPAC D water

acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

 

not relevant for a liquid

acceptable

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

not relevant for a liquid

acceptable

B.2.2.22

(IIIA 2.8)

Wet sieve test

GLP: no

Method: CIPAC MT 167

no residue on 75 µm sieve

acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

 

not relevant for a liquid

acceptable

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

not relevant for a liquid

acceptable

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

not relevant for a liquid

acceptable

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

not relevant for a liquid

acceptable

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

not relevant for a liquid

acceptable

B.2.2.28

(IIIA 2.8)

Flowability

 

not relevant for a liquid

acceptable

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

GLP: no

Method: CIPAC MT 148

residue 2.60%, rinsed residue 0.17%

acceptable

B.2.2.30

(IIIA 2.8)

Dustability

 

not relevant for a liquid

acceptable

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

not relevant for a liquid

acceptable

2.9.1

Physical compatibility with other products

GLP: no

Method: in-house method

The test substance (0.5% in water of hardness 20, 342 or 500 mg/kg) was mixed with each of a range of other products and allowed to stand at 25°C for 24 hours. Separation was recorded after 0.5, 2, 6 and 24 hours, and re-emulsifiability and the residues on a 125 and 250 µm sieve after 24 hours. The product was compatible with Rebell, Fusilade Max, Gallant Super, Targa D+, Lontrel 100, Safari, Venzar, Mineral Oil, Tramat 500, Goltix WG, Tramat 500 + Goltix WG 1:1, Pyramin, Kemifam flow, PMP 471 and Betanal Compact flo, but not with Furore Super and Actirob B.

Acceptable, although the products tested did not include any product based on phenmedipham with a current authorization in The Netherlands, although the label recommends mixing with phenmedipham. However it can be expected that phenmedipham would not present other problems.

 

2.9.2

Chemical compatibility with other products

 

In the report of the previous study, it was stated that chemical compatibility was evaluated by means of comparing the structural formula and the chemical properties of the ingredients inside the tank mix. The reported conclusions for chemical compatibility were the same as for physical compatibility.

acceptable:

there is no test available. As there were no reactions visible this can be accepted.

 

No mixing with plant protection products or adjuvants, other than mentioned in the table above (2.9.1), is proposed. No information is available on the behaviour of this product when mixed with other products.

 

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, March 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)

The sample was dissolved in an organic solvent, and ethofumesate was determined by GC-FID or HPLC-UV using an internal standard technique.

Impurities in technical as (principle of  method)

The four main impurities of technical ethofumesate were determined by gradient HPLC-UV. A fifth impurity was determined by GC-FID.

Preparation (principle of method)

HPLC-UV with internal standard

 

Conclusion

The analytical methods for technical a.s. and impurities have been assessed in the monograph and were considered to be acceptable. The analytical method for the determination of the technical a.s. in the preparation was submitted with the present application for renewal and is acceptable.

 

3.2       Residue analytical methods

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

Sugar beet: Samples were extracted with acetone/water, filtered and re-extracted with dichloromethane. After clean-up on Florisil, ethofumesate was determined by GC-FPD/NPD. LOQ = 0.01-0.05 mg/kg.

Sugar beet: Samples were extracted with ethyl acetate/hexane. A silica gel cartridge and a C18 cartridge were used to clean up the combined extracts. Residues of ethofumesate and NC 9607 were determined by GC-MSD Multi-residue analysis. LOQ = 0.05 mg/kg.

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

Samples were extracted with acetonitrile, concentrated to dryness, re-dissolved, followed by clean-up on HPLC and solid phase, concentrated to dryness, re-dissolved, and analysed by GC-MS. LOQ = 0.1 mg/kg.

Soil (principle of method and LOQ)

Residues of ethofumesate in soil samples were extracted with acetone, concentrated, extracted with dichloro­methane, concen­trated to dryness, re-dissolved, cleaned-up on silica or Florisil, and analysed by HPLC-UV or GC-MS. LOQ = 0.01-0.05 mg/kg.

Water (principle of method and LOQ)

Water & drinking water: Samples were extracted with dichloromethane, concentrated to dryness, re-dissolved in cyclohexane and analysed by GC-FPD. LOQ = 0.05-0.1 µg/l.

Surface water: SPE extraction, GC-MS. LOQ = 0.1 µg/l.

Air (principle of method and LOQ)

A volume of air was drawn through a RP-18 cartridge. Ethofumesate was eluted with isopropanol, concentrated to dryness, re-dissolved, and analysed by GC-MS. LOQ = 0.02-0.1 mg/m3.

Body fluids and tissues (principle of method and LOQ)

Samples of dog plasma were extracted with ethyl acetate, concentrated to dryness, re-dissolved, and analysed by HPLC-UV. LOQ = 0.1 mg/ml.

 

The above residue analytical methods have been assessed in the monograph and were considered to be acceptable, except the methods for animal products, which were sufficiently validated for pork fillet only. A fully validated residue analytical method for animal products is not required, because no MRL is set; no residues in food/feed of animal origin are expected.

 

Definition of the residue and proposed MRLs for ethofumesate

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

Sugar and fodder beet: not applicable (residues in sugar are not anticipated)

not applicable

Food/feed of animal origin

Ethofumesate

not required

 

Required LOQ

Soil

Ethofumesate

0.05 mg/kg

Drinking water

Ethofumesate

0.1 µg/L (Dutch drinking water guideline)

Surface water

Ethofumesate

320 µg/L (NOEC for Daphnia magna)

Air

Ethofumesate

0.75 mg/m3 (derived from the AOEL 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

 

Residue analytical methods are available but not required for the proposed use on sugar and fodder beet, since this use is not anticipated to produce residues in plant and animal products for human consumption.

 

The residue analytical methods for water, soil and air, evaluated in the monograph, are acceptable and suitable for monitoring of 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

None.

 

3.4       Physical-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)

-

-

 

This labeling is in accordance with the labeling in the monograph (2003).

 

Proposal for the classification and labeling 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:

 

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

-

-

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

N.a.

Tactile warning of danger obligatory?

N.a.

 

Explanation:

Hazard symbol:

 

Risk phrases:

 

Safety phrases:

 

Other:

 

 

The proposed labeling above is different to the previous decision regarding the labeling of the plant protection product Tramat 500 (dated 10 December 2004).

 

4.      Mammalian toxicology

Ethofumesate is included in Annex I of Directive 91/414/EC (Directive 2002/37/EC, 4 May 2002).The List of End Points for ethofumesate is copied from the review report  (SANCO/6507/VI/99-final, 15 May 2002). NL remarks are presented in  italics.

 

Absorption, distribution, excretion and metabolism in mammals

Rate and extent of absorption:

Up to 100 % absorbed. Urine and bilary excretion are the same. Value based on oral and iv. dosing.

Distribution:

Widely distributed.

Potential for accumulation:

No evidence of accumulation

Rate and extent of excretion:

Rapid and almost complete within 24 h. Mainly via urine (approximately 90 %)

Toxicologically significant compounds:

Parent compound and metabolites

Metabolism in animals:

Extensively metabolised. Hydrolysis, oxidation and ring opening.

 

 

Acute toxicity

Rat LD50 oral:

> 5 000 mg/kg bw

Rat LD50 dermal:

> 2 000 mg/kg bw

Rat LC50 inhalation:

> 0.3 mg/l (whole-body exposure, dust aerosol)1

Skin irritation:

Non-irritant.

Eye irritation:

Non-irritant.

Skin sensitization (test method used and result):

Non-sensitising (M&K, Buehler).

1 In the monograph for ethofumesate another acute inhalation study is summarized with an LC50 of > 3.97 mg/L (4 h nose only, highest attainable concentration). Based on this study ethofumesate does not classify for acute inhalation toxicity.

Short term toxicity

Target / critical effect:

Increased liver and kidney weights

Lowest relevant oral NOAEL / NOEL:

250 mg/kg bw/d (90-day oral study in dog)

Lowest relevant dermal NOAEL / NOEL:

1 000 mg/kg bw/d (21-day dermal study in rabbit)

Lowest relevant inhalation NOAEL / NOEL:

Data not required.

 

 

Genotoxicity

No genotoxic potential. One test was positive but was not done according to OECD Guidelines. All other tests were negative (15 tests).

 

 

Long term toxicity and carcinogenicity

Target / critical effect:

Liver

Lowest relevant NOAEL:

7 mg/kg bw/d; 2-year feeding study in rat

Carcinogenicity:

No carcinogenic potential

 

Reproductive toxicity

Target / critical effect - Reproduction:

Decreased pup weight at parental toxic dose levels

Lowest relevant reproductive NOAEL / NOEL:

78 mg/kg bw/d; multigeneration study in rat (Tesh-1980)2

Target / critical effect - Developmental toxicity:

Foetotoxicity.
Increased incidences of resorption at maternal toxic dose levels.
Increase in the delayed ossification is not significant at litter toxic dose levels.

Lowest relevant developmental NOAEL / NOEL:

300 mg/kg bw/d (developmental study in rabbit)3

2 Also parental NOAEL

3 Also maternal NOAEL

Delayed neurotoxicity

Data not required. No indication from other studies.

 

 

Other toxicological studies

Data not required.

 

 

Medical data

General survey of accessible literature: no adverse effects in humans exposed.

 

Summary

 

 

Value

Study

Safety factor

ADI:

0.07 mg/kg bw/d

2-y rat (Suresh‑95)

100

AOEL systemic:

2.5 mg/kg bw/d

90-d dog (Brownlie-94)

100

ARfD (acute reference dose):

Not required

 

 

 

 

Dermal absorption

No data. Default value of 10% is used for calculations.

 

 

 

 

Data requirements active substance

None

 

4.1 Toxicity of the formulated product (IIIA 7.1)

 

The formulation Tramat 500 does not need to be classified on the basis of its acute oral (LD50 rat >2100 mg/kg bw), dermal (LD50 rat >4100 mg/kg bw), and inhalation toxicology (No study, not required).

The formulation Tramat 500 does not need to be classified for dermal irritation, eye irritation or skin sensitisation.

 

4.1.1 Data requirements formulated product

None.

 

4.2 Dermal absorption (IIIA 7.3)

NL commented on dermal absorption for ECCO76, WG-Evaluation and WG-Legislation. Based on physical chemical parameters (Mol. Weight 286, logPow 2.7) and the almost complete oral absorption  the value for dermal absorption may be much higher. In the absence of data a default value of 100% should be used.  Since the dermal absorption is a formulation related property, NL can deviate from the value in the List of End Points. For risk assessment a value of 100% will be used.

 

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

Other formulants: no reason for toxicological concern.

 

 

4.4 Exposure/risk assessments

 

Overview of the proposed uses

The intended use of Tramat 500 is as fungicide in sugar and fodder beets. The dose is 0.3. to 1 L Tramat 500 per hectare, 1-2 times per season. The period of application is in spring and is less than 3 months. A risk assessment for semi-chronc exposure is sufficient, also for contract workers. Tramat 500 has to be used in combination with phenmedipham.

 

Calculation of the AOEL

In the EU the AOEL for semi chronic exposure is set at 2.5 mg/kg bw/day, based on the NOAEL of 250 mg/kg bw/day in a 90 day  oral study in dogs. For a 70 kg operator this is 175 mg/day.

 

4.4.1 Operator exposure/risk

Exposure to ethofumesate during mixing and loading and application of Tramat 500 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. Calculations below are only performed with the maximum dose of 1 L Tramat/ha.

Tabel T.Y Internal operator exposure to ethofumesate and risk assessment for the use of Tramat 500]

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on sugar and fodder beets.

Mixing/

Loading

Respiratory

0.025

175

<0.01

Dermal

100

175

 0.6

Application

Respiratory

0.040

175

<0.01

Dermal

15

175

0.1

 

Total

115

175

0.7

a       exposure was estimated by  EUROPOEM

·       biological availability via the dermal route:   100% (default value)

·       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 calculation is 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.

 

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

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 ethofumesate as a result of the application of Tramat 500 in sugar and fodder beets.

 

Bystander

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to ethofumesate during application of Tramat in sugar and fodder beets.

 

Worker

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 sugar and fodder beets due to exposure to ethofumesate after application of Tramat 500.

 

 

 

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

none

 

4.7 Combination toxicology

Tramat 500 is only effective in combination with phenmedipham (2-5 L/ha, 157 g phenmedipham/L). Phenmedipham is also included in Annex I of Direction 91/414/EC (Directive 2004/58/EC, 6 October 2004). Possibly, the combined exposure to these active substances may lead to a different toxicological profile than the profile that is based on the individual substances.

 

The critical effect  of phenmedipham after short- and long term exposure in mammals  is  on the red blood cells (methemoglobinemia and anemia, with related pathology in spleen, liver and kidneys). The EU-AOEL for phenmedipham is 0.13 mg/kg bw/day (9.1 mg/day for a 70 kg operator). Maximum total systemic exposure is 1.94 mg/d (risk index: 0.21).

Based on the different toxicological profile and the low risk indexes for the unprotected operator, no extra risk for the operator is expected due to the combined exposure to ethofumesate and phenmedipham as a result of  application of Tramat 500.

 

 

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:

-

Indication of danger:

-

R phrases

-

-

S phrases

-

-

Special provisions:
DPD-phrases

DPD-14*

Safety data sheet available for professional user on request.

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?

n.a.

Tactile warning of danger obligatory?

n.a.

 

Explanation:

Hazard symbol:

see Risk phrases

Risk phrases:

Xi, R43 is no longer assigned based on a new LLNA study with the formulation.

Safety phrases:

S36/37 does not need to be assigned, as Xi, R43 are no longer required

Other:

DPD-14 does not need to be assigned when the formulation is classified for other aspects.*

 

 

5.      Residues

 

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

Sugar beet (root crops), rye grass (cereals), onion (root crops), tobacco (leafy vegetables), wheat (cereals), radish (root crops) and cabbage (leafy vegetables).

Rotational crops

Root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach, cabbage) and cereals (wheat, grain, corn)

Plant residue definition for monitoring

Ethofumesate and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate (AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methyl-propionic acid (AE C520645; free and conjugated)

 

Plant residue definition for risk assessment

Ethofumesate and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate (AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methyl-propionic acid (AE C520645; free and conjugated).

Conversion factor (monitoring to risk assessment)

None

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

 

...............................................................................

Root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach) and cereals (wheat, grain, corn)

 

 

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

Animals covered

Cow and hen (parent compound only)

Animal residue definition for monitoring

Ethofumesate (2-Ethoxy-2,3-dihydro-3,3-dimethyl-benzofuran-5-yl-methane sulphonate) and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate ( AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methylpropionic acid (AE C520645; in free form only).

 

Animal residue definition for risk assessment

Ethofumesate (2-Ethoxy-2,3-dihydro-3,3-dimethyl-benzofuran-5-yl-methane sulphonate) and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate ( AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methylpropionic acid (AE C520645; in free form only).

 

Conversion factor (monitoring to risk assessment)

-

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

Log Pow parent compound: 2.7

Log Pow NC 20 645: Data not available.

 

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

 

....................................................................

Root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach) and cereals (wheat, grain, corn)

 

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

 

....................................................................

Ethofumesate and the two conjugated metabolites NC 9607 and conjugated NC 8493 were not degraded during prolonged storage (maximum 54 weeks) of frozen samples of sugar beet plants.

Ethofumesate and NC 9607 residues in fortified samples of sugar beet tops, and ethofumesate residues in fortified samples of sugar beet roots did not significantly decline after storage at -20 °C for up to 24 months. But, NC 9607 residues in fortified samples of sugar beet roots gave a mean recovery of 77 % after 24 months storage at -20 °C.
Studies on cereals, leafy vegetables and root crops will not be evaluated for the time being.

 

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

Not required as the notifier has announced that there is no intended use in grassland. According to extrapolation from a new metabolism study (C 003362) all residues in a dairy cow, all tissues (including liver and kidney) and milk would be below LOQ. A new estimation of ethofumesate intake (1x) via fodder crops by RMS (17 December 1999) resulted in a total intake of 0.72* ppm in dairy cows and 0.87** ppm in beef cows (will be included in the addendum to the monograph). According to 7031/VI/95 rev 4, livestock feeding studies are however, only required when total diet is: ³0.1 ppm and metabolism studies indicate that significant residues (0.01 ppm or above the LOQ) may occur in edible animal tissue when taking account of the potential 1x dose rate. If current uses in fodder crops (sugar beet tops and roots (molasses), fodder beet tops, mangold tops and roots and pulses) also are the only intended uses, there seems to be no need for a new livestock feeding study.

 

8.05.2000:

*Erratum: Change to 0.91 ppm

**Erratum: Change to 0.89 ppm

 

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Crop/processed crop

 

Number of studies

Transfer factor

% Transference

 

Sugarbeet/Sugar

 

4

0.1-0.3

Not possible to calculate

Sugarbeet/Molasses

 

4

6-24

Not possible to calculate

Sugarbeet/Wet pulp

 

3*

0.2-0.4

Not possible to calculate

Sugarbeet/Thick juice

 

5

4-5

Not possible to calculate

Sugarbeet/Thin (raw) juice

 

5

0.5-1.9

Not possible to calculate

* Substrates in studies R19 and R41 were not analysed

 

 5.1. Summary of residue data

 

5.1.2 Metabolism in livestock

For sugar- and fodder beet no MRL is established. The proposed ‘MRLs’ for risk assessment are 0.3 and  0.1 mg/kg for beet tops and beet root, respectively.  For  peas, a MRL of 0.05* mg/kg is established. With these residue levels, a dietary burden of 0.87, 0.91 and 0.22 mg/kg dry feed was calculated for dairy cattle, beef cattle and poultry, respectively (addendum to the draft assessment report, d.d.d December 12th, 2000).

 

Metabolism in ruminants was investigated in sheep (single dose of ca. 4 mg/kg dry feed ) and cow (7 daily doses of 13 mg/kg dry feed, 15N). Metabolism in hens was investigated (14 daily doses of 10 mg/kg dry feed, 400N). Metabolism in ruminant and rat are similar, so no studies with pigs are required.

 

No siginificant residues were detected in animal tissues; and is was concluded that no residues are expected above the LOQ at the proposed GAP on sugar beet, fodder beet and peas.


 

5.1.5 Residue data

During the European evaluation it was decided that due to persistency problems, the maximum amount of ethofumesate applied should not exceed 1.0 kg ai/ha/season. The Dutch GAP of TRAMAT 500 is less critical than the EU-GAP: maximum of 550 g ai/ha/season.

 

Sugar and fodder beet root

Critical GAP-NL is 550 g ai/ha/season before or at BBCH 14 (4 leave stage). Hundred forty five studies are described in the draft assessment report with sugar- or fodder beet. Studies were performed with 1-4 applications of about 300 g ai/ha or 1 application of 1-1.5 kg/ha. In most of the studies, residues decreased to < LOQ. Only at the highest dose level residues above 0.05 but below 0.1 mg/kg were detected. Therefore, for the intended use, residues are expected < 0.05* mg/kg in beet root.

 

Sugar- and fodder beet tops

Residues were determined in sugar beet and fodder beet tops. Residues were somewhat higher in fodder beet tops, up to 0.18 mg/kg at an application rate of 2.0 kg ai/ha/season.

 

Data for calculation of livestock dietary burden

During the EU-evaluation an ‘MRL’ for risk assessment of 0.3 mg/kg was calculated for beet tops. An ‘MRL’ for risk assessment of 0.1 mg/kg was calculated for fodder beet roots. These values of 0.3 and 0.1 mg/kg for beet tops and beet root, respectively, were used for calculating the livestock dietary burden.

 

 

5.1.9 Calculation of the ADI and the ARfD

The ADI was taken from the final list of end points of human toxicology. The ADI was calculated from the NOAEL of 7 mg/kg bw/d from the 2y oral rat study, based on body weight gain at the near highest dose group of 70 mg/kg bw/d. A default safety factor of 100 was assumed to be appropriate to account for these adverse effects.

 

Derivation of an ARfD was not considered necessary.

 

5.2 Maximum Residue Levels

MRLs have been harmonised by directive 2003/60/EC. MRLs are set for red beet root (0.1 mg/kg) and peas (0.05* mg/kg).

 

The product complies with this MRL Directives.

 

5.3 Consumer risk assessment

Risk assessment for chronic exposure through diet

Based on the proposed residue tolerances, a calculation of the National Theoretical Maximum Daily Intake (NTMDI) was carried out using the National Dutch diet. Calculation of the NTMDI shows that < 1% of the ADI is used for both the general population and for children.

 

Risk assessment for acute exposure through diet

A calculation of the National Estimated Short Term Intake (NESTI) was not carried out since no ARfD was established.

 

Conclusion

No risk is foreseen for consumers when authorising TRAMAT 500 on sugar beet and fodder beet following the requested intended use.

 

5.4 Data requirements

-

 

 

 

6.                  Environmental fate and behaviour

 

 

List of Endpoints Fate/behaviour and Ecotoxicology

 

Ethofumesate

 

Fate and behaviour in the environment

 

Fate and behaviour in soil

 

Route of degradation

 

Aerobic:

 

Mineralization after 100 days:

Range 6 - 13%; median 8.7%; n=5

Non-extractable residues after 100 days:

Range 16 - 34%; median 31%; n=5

Major metabolites above 10 % of applied active substance: name and/or code
% of applied rate (range and maximum)

All less than 6%

 

 

Supplemental studies

 

Anaerobic:

Not relevant because of very slow transformation

 

 

Soil photolysis:

DT50  two studies :

14 d; =290nm, 24 h light, 1.5 kg a.s./ha

65 days; 300-800 nm, light 12h per day, 15 mg as/kg.

 

 

Remarks:

None

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 °C, aerobic):

40 - 75% WHC:

range 47 – 211 d; mean 97 d; median 84 d; n=10

DT90lab (20 °C, aerobic):

40 - 75% WHC:

range 210 – 701 d; median 331 d; n=10

DT50lab (10 °C, aerobic):

No study.

Calculation of DT50, 10°C carried out on eight DT50 laboratory tests (20-21°C, aerobic) using Q10=2.2.

Result: DT50, (10°C, aerobic) (calc.) = 198 d

DT50lab (20 °C, anaerobic):

Very slow transformation: 90-100% unaltered

after 60 d; n=2

 

Field studies (country or region)

 

DT50f from soil dissipation studies:

Germany: One dose range 0.8 - 6.5 kg as/ha: range 15 - 250 d; median 65 d; n=10. Not dose related

UK: One dose 1.5 kg as/ha: 36 and 56 d; mean 46 d; n=2

California, USA: 2.1 kg as/ha: 75 d. n=1

Calculated mean of all = 77 d; median = 56 d;

n=13

DT90f from soil dissipation studies:

Germany: One dose range 0.8 - 6.5 kg as/ha: range 3 months - >3 years; median ca.11 months; n=11.

UK: One dose 1.5 kg as/ha: 4 and 4.6 months, mean 4.3 months; n=2

Soil accumulation studies:

No relevant data.

Calculated based on a field DT50 = 119 days

a) Application of 1.0 kg as/ha and year, a plateau concentration of 114% of maximum PECsoil reached after 3 years. Plateau concentration 1.5 mg as/kg soil.

b) Application 1.0 kg as/ha each third year. There was no significant accumulation. Three years after applic. 0.1% of dose remained.

Soil residue studies:

Data not required.

 

 

Remarks:
e.g. effect of soil pH on degradation rate

 

None.

 


Adsorption/desorption

 

Kf / Koc:

 

Kd

 

pH dependence:

Koc: range 97 - 245; mean = 147; median 132; n=11

 

Kd: range 0.73 – 6.2; mean = 2.7; median 2.3; n=11

 

Not pH dependent.

 

Mobility

 

Laboratory studies:

 

Column leaching:

According to BBA Guideline (200 mm over 2 d): n.d.-2.9% as; n=9

Other method (508 mm over 15 - 20 d): 4.2-67% of applied radioactivity; n=4

Aged residue leaching:

Three different methods: n.d.-4.2% of applied initial radioactivity; n=5

 

 

Field studies:

 

Lysimeter/Field leaching studies:

Two studies according to BBA guideline:

 

Three lysimeters with loamy sand soil. Lysimeter with a surface area of 0.5 m2 and a depth of 1.0 m. One dose of 1.25 kg as/ha applied pre-emergence to sugar beet on silty sand in April 1992. An approximate mean rainfall of 857 mm/year. Terminated after 2 years.
LOD = 0.1 µg/L

Two lysimeters with a sandy soil. Lysimeter with a surface area of 1.0 m2 and a depth of 1.2m. One dose of 1.5 kg as/ha applied to fodder beet on sandy soil in both lysimeters in May year 1 and additionally to one soil in May year 2. Total rainfall (4 years) 3280 mm. Terminated after 3 years.
LOD = 0.01 µg/L

Results: No detected active substance or metabolite in leachate in any of the lysimeters.

 

 

Remarks:

None.

 

Fate and behaviour in water

Abiotic degradation

 

Hydrolytic degradation:

pH 5.0, 7.0, 9.2: Negligible

Major metabolites:

None.

Photolytic degradation:

Artificial light: (greatly variable results)
37-62 d (summer, 40-60
ºN)
4.6 d  (on a year basis) / 2.6 d (for month May)

Major metabolites:

None identified.

 

 

Biological degradation

 

Readily biodegradable:

Not readily biodegradable; n=3

Water/sediment study:

Calculations: 3 out of 5 according to first order kinetics, 2 out of 5 according to 1.5th order kinetics

DT50 water:

Study 1: 13 days, n=1 (1st order)

Study 2: 11 and 19 days, n=2 (1st and 1.5th order)

Study 3: 7 and 50 days, n=2 (root of 1st order)

DT90 water:

Study 1:   -

Study 2: 121 and 212 days, n=2

Study 3: -

DT50 whole system:

Study 1: 125 days, n=1, (1st order)

Study 2: 105 and 153 days, n=2 (1st and 1.5th
order)

Study 3: 242 and 285 days, n=2 (root of 1st
order)

DT90 whole system:

Study 1: -

Study 2: 507 and 550 days, n=2

Study 3: -

Distribution in water / sediment systems
(active substance)

Study 1: After 84 days, 14% of applied radioactivity as parent compound in water / 51% in sediment, n=1. Maximum 53% parent compound in the sediment after 63 days of incubation. No DT50 calculated for the sediment.

Study 2: After 103 days, 13-18% of applied radioactivity as parent compound in water / 37-41% in sediment. Maximum 48 – 49 % of applied as parent compound in the sediment after 30 days of incubation. Thereafter DT50 in the sediment 170 – 270 days.

Study 3: After 225 and 234 days, 21 and 1.5% of applied radioactivity as parent compound in water / 30 and 53% in sediment. No DT50 calculated for the sediment.

Distribution in water / sediment systems
(metabolites)

Maximum of 4 unknown metabolites,
altogether up to 17% of applied radioactivity.

Accumulation in water and/or sediment:

Considered not relevant since active substance is applied every third year.

Rate of mineralisation

 

Non-extractable residues

6-9%

 

27%

Degradation in the saturated zone

Degradation in the saturated zone: No study.  Not required.

 

 

Remarks:

None.

 

Fate and behaviour in air

Volatility

 

Vapour pressure:

6.5 x 10-4 Pa (25 °C)

Henry's law constant:

6.8 x 10-4 Pa×m3×mol -1 (25 °C)

 

 

Photolytic degradation

 

Direct photolysis in air:

Data not required.

Photochemical oxidative degradation in air

DT50:

2.1 h, calc. according to Meyland and Howard (AOP)

4.1 h, calc. According to Atkinson

Volatilisation:

From plant surfaces:

22% lost from plant surface during 24 hours

From soil:

15% lost from soil surface during the first 24 hours

 

 

Remarks:

No remarks.

 

 

Phenmedipham

 

Phenmedipham is an existing active substance placed on Annex I. For the risk assessment on environmental apsects of phenmedipham the EU-list of endpoints has been used. Further, additional data have been used submitted by the applicant. These are added in italics in the list of endpoints.

 

Fate and behaviour in the environment

 

Fate and behaviour in soil

 

Route of degradation

 

Aerobic:

 

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)

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)

Major metabolites above 10 % of applied active substance: name and/or code
% of applied rate (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)

 

 

Supplemental studies

 

Anaerobic:

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:

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)

 

 

Remarks:

None

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 °C, aerobic):

26, 42, 43 d, mean=37 days (n=3, r2 = 0.932 - 0.953)

MHPC: 12, <3, <3 d, mean= 6 d

DT90lab (20 °C, aerobic):

85, 138, 143 days (n=3, r2  = 0.932 – 0.953)

DT50lab (10 °C, aerobic):

27 days

DT50lab (20 °C, anaerobic):

15 days (n=1, r2 = 0.934)

 

 

Field studies (country or region)

 

DT50f from soil dissipation studies:

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, r2  not 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 from soil dissipation studies:

DT90f: Germany, sites described above:

range 30 - 133 days, mean 82 days (n=4 , r2  not available, 1st order)

Soil accumulation studies:

no data submitted nor required

Soil residue studies:

no data submitted nor required

 

 

Remarks:

e.g. effect of soil pH on degradation rate

no clear pH dependence

 


Adsorption/desorption

 

Kf / Koc:

PMP






MHPC







pH 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

 

Laboratory studies:

 

Column leaching:

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

 

Aged residue 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.

 

 

Field studies:

 

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 Phenmedipham 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).

 

 

Remarks:

No groundwater contamination expected

 

Fate and behaviour in water

 

Abiotic degradation

 

Hydrolytic degradation:

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)

Major metabolites:

MHPC

Photolytic degradation:

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

Major metabolites:

None

 

 

Biological degradation

 

Readily biodegradable:

no

Water/sediment study:

DT50 water:
DT90 water:
DT50 whole system:

DT90 whole system:


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)

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

Accumulation in water and/or sediment:

Due to quite rapid degradation of PMP and MHPC no accumulation is expected

 

 

 

Degradation in the saturated zone

no data submitted nor required

 

 

Remarks:

Rapid hydrolysis of PMP in neutral and alkaline pH

to MHPC

 

Fate and behaviour in air

 

Volatility

 

Vapour pressure:

7 x 10-10 Pa at 25 °C

Henry's law constant:

5 x 10-8 Pa x m3 x mol-1

 

 

Photolytic degradation

 

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

Volatilisation:

from plant surfaces: no data

from soil surface: no data

 

 

Remarks:

PECair considered negligible

 


 

6.1              Fate and behaviour in soil

 

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

 

6.1.1        Persistence in soil

 

Ethofumesate

The following laboratory DT50 values are available for the active substance ethofumesate: range: 47 – 211 days (average 97 days, median value: 84 days). The mean DT50-value of the a.i. can thus be established to be > 90 days. It can be excluded that after 100 days there will be more than 70% bound (non-extractable) residues of the initial dose together with the formation of less than 5% CO2 of the initial dose.

 

Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for the active substance, it has to be demonstrated by means of field dissipation studies that the field DT50 is < 90 days. There are field data provided: mean DT50 = 77 days, range 15 – 250 days, median DT50 = 56 days.

 

From the results it is shown that the average field DT50 is < 90 days. Therefore, the standards for persistence as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

 

In the Annex I review report it was advised to maximise the dosage of ethofumesate to 1.0 kg a.s./ha once every three years. However, the actual risk assessment regarding the persistence gives no reason to follow this restriction.

 

The concentration of the a.s. in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PIECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1400 kg/m3. See Table M.2a for input values and results.

 

Table M.2a PEC soil calculations (5 cm)

Use

Rate

[kg a.s./ha]

Frequency

Fraction on soil

PECsoil

5 cm

(mg/kg)

PECsoil28d, wet

5 cm

(mg/kg)

sugar- and fodderbeets

ethofumesate  max 0.5

1

0.7

0.47

0.37

 

Phenmedipham

The following laboratory DT50 values are available for the active substance phenmedipham: 42, 26 and 43 days (mean 37 days). The mean DT50-value of the a.i. can thus be established to be < 90 days. The available field DT50 values are 5.8, 9.0, 15.7 39.9 and 13.3 days. Hence, also under field conditions the DT50 < 90 days. Furthermore it can be excluded that after 100 days there will be more than 70% bound (non-extractable) residues of the initial dose together with the formation of less than 5% CO2 of the initial dose.

 

For the metabolite MHPC the following DT50-values are available: 12, <3, <3 days (mean: 6 days). The mean DT50 value of the metabolite can thus be established to be < 90 days.

 

From the results it is shown that the standards for persistence as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

 

The concentration of phenmedipham in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PIECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1400 kg/m3. See Table M.2b for input values and results.

 

Table M.2b PEC soil calculations (5 cm)

Use

Rate

[kg a.s./ha]

Frequency

Fraction on soil

PECsoil

5 cm

(mg/kg)

PECsoil28d, wet

5 cm

(mg/kg)

sugar- and fodderbeets

phenmedipham  max 0.8

1

0.7

0.75

0.51

 

6.1.2    Leaching to shallow groundwater

 

Ethofumesate

The leaching potential of the a.s. (and metabolites) is calculated in the first tier according to the RUUBG, using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. 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 application rate [0.5 kg/ha], the crop  and an interception value appropriate to the crop of 0,3 (user defined, from FOCUS groundwater report (Werner, Adi)) [1].

 

The following input data are used for the calculation:

 

PEARL:

 

Ethofumesate:

Median DT50 for degradation in soil (20°C): 84 days (range 47-211 days)

Median Kom (pH-independent): 77 L/kg (range 57-144 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

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for ethofumesate following spring application (first day of application April 25), see table M.3a.

 

Table M.3a Leaching ethofumesate as predicted by PEARL 2.2.2

Use

Substance

Rate substance

Frequency

Interval

Intercep-tion

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

sugar- and fodderbeets

ethofumesate

0.5

1

10

0.3

1.093

 

 

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.3a it reads that the expected leaching based on the PEARL-model calculations for ethofumesate larger is than 0.1 µg/L. Therefore, further study into the leaching behaviour is necessary.

 

The applicant submitted a Focus degradation kinetics evaluation study, in which the available field DT50 values were evaluated and standardised for groundwater modelling. These normalised DT50 values ranged from 5.9 to 193 days. The geometric mean is 41.8 days. This DT50 value can be used for refined assessment.

 

Table M.3b Leaching ethofumesate as predicted by PEARL 2.2.2, using normalised field DT50 values

Use

Substance

Rate substance

Frequency

Interval

Intercep-tion

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

sugar- and fodderbeets

ethofumesate

0.5

1

10

0.3

0.028

 

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.3a it reads that the expected leaching based on the PEARL-model calculations for ethofumesate larger is than 0.01 µg/L. Therefore, further study into the leaching behaviour is performed.

 

The applicant also stated that beet cultivation is always included in crop rotation schedules, and that the application of ethofumesate is thus restricted to once every three year. However, formulations with ethofumesate are also allowed in several other crops, which could also be included in the crop rotating system. Therefore, this statement can only be included with an additional restriction for use. Since lysimeterstudies are available, this restriction is not necessary.

 

Lysimeterstudies

There are two lysimeterstudies available. The results of these two experiments showed that no ethofumesate or metabolites were found in the percolate water. However, on basis of the submitted data it is not clear if these lysimeters are more vulnerable than the Dutch scenario for all relevant aspects. For that reason a standardisation for the Dutch circumstances according to Verschoor (2001) is necessary.

This standardisation has been performed. For this standardisation the percolate concentration has been put on 0.0049 µg/L, just below the detection limit, to be able to calculate the cumulative leaching from the lysimeter. Because there are no DT50 and Kom values for the lysimetersoil available, worst-case values have been used (lowest DT50 value and the highest Kom-value). The simulation fault (SE) is calculated by Slysi/Mlysi, the simulated leaching divided by the measured leaching. For the lysimeters simulation faults are calculated of 11 and 9.1 (mean 10.05). If the simulation fault is used as correction factor according to the formula Starget = Starget/SE, the corrected maximum calculated concentration in the groundwater is 0.0028 µg/L. This value is lower than 0.001 µg/L and therefore it can be concluded that the standards for leaching to groundwater as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

 

Monitoring data

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

 

Phenmedipham

The leaching potential of the a.s. (and metabolites) is calculated in the first tier according to the RUUBG, using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. 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 application rate 0.8 kg/ha, the crop  and an interception value appropriate to the crop of 0.3.

 

The following input data are used for the calculation:

 

PEARL:

 

Phenmedipham:

Median DT50 for degradation in soil (20°C): 37 days (range 26 – 43 days)

Median Kom (pH-independent): 522 L/kg (range 386 – 631 L/kg) .

 

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

Solubility in water: 0.0018 g/L (25 ºC)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC

Median DT50 for degradation in soil (20°C): 6 days (range <3 - 12 days)

Median Kom (pH-independent): 129 L/kg (range 34 - 276 L/kg)

 

Maximum formation percentage of MHPC: 54%

 

Application rate parent compound: 0.8 kg a.s./ha

Frequency: 2

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for phenmedipham and the metabolite MHPC following spring application, see table M.3b.

 

Table M.3b Leaching of phenmedipham and MHPC as predicted by PEARL 2.2.2

Use

Substance

Rate substance

Frequency

Interval

Intercep-tion

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

sugar- and fodderbeets

phenmedipham

MHPC

0.8

1

10

0.3

< 0.01

< 0.01

 

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.3b it reads that the expected leaching based on the PEARL-model calculations for phenmedipham and metabolite MHPC lower is than 0.01 µg/L. Therefore it can be concluded that the standards for leaching to groundwater as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met for phenmedipham and its metabolite.

 

Conclusions

The product complies with the requirements laid down in Annex VI of Council directive 91/414/EEC concerning 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 ethofumesate and phenmedipham 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 the following input is used (all on the basis of mean values):

 

TOXSWA:

 

Ethofumesate

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

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

 

Kom for suspended organic matter: 78 L/kg

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

 

Phenmedipham

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

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

 

Kom for suspended organic matter: 454 L/kg

Kom for sediment: 454 L/kg

 

Saturated vapour pressure: 7 x 10-10 Pa (25 ºC)

Solubility in water: 0.006 g/L (25 ºC)

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

 

Saturated vapour pressure: 7 x 10-10 Pa  (25 ºC)

Solubility in water: 0.0018 g/L (25 ºC)

 

Formation percentage MHPC: 70%

Relative molecular weight : 0.557

 

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.

 

In table M.4, the drift percentages and calculated surface water concentrations for the active substance ethofumesate and phenmedipham for the intended use are presented.

 

Tabel M.4 Overview of surface water concentrations for active substance and metabolite(s) following spring application

Use

Substance

Rate a.s.

[kg/ha]

Drift

[%]

freq

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

 

 

 

 

 

spring

spring

spring

sugar- and fodderbeets

ethofumesate

phenmedipham

combination

 

metabolite MHPC

0.5

0.8

1.0

1.0

1

1

2.38

3.80

6.18

 

1.48

2.13

0.082

2.21

 

0.90

2.06

0.061

2.12

 

0.78

sugar- and fodder beets (application by aircraft)

ethofumesate

phenmedipham

combination

 

metabolite MHPC

0.5

0.8

5.0

5.0

1

1

11.9

19.0

30.9

 

7.42

10.65

0.41

11.1

 

4.49

10.3

0.31

10.6

 

3.91

* 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 ethofumesate and 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 to establish whether the product has no effect that is unacceptable for the environment. 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.

In co-operation with the VEWIN a list has been composed of substances which might form a problem at drinking water intake points.  This list is based on measurements in surface water from the period 1995-2001. Ethofumesate and phenmedipham are not on this list. Therefore the product complies with the requirements laid down in Annex VI of Council directive 91/414/EEC concerning the drinking water criterion.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

Ethofumesate is slightly volatile. The vapour pressure is  6.5 x 10-4 Pa at 25 ºC.

 

Phenmedipham is little volatile. The vapour pressure is 7 x 10-10  Pa at 25 °C.

 

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

-    Further research into the leaching behaviour of ethofumesate is necessary (e.g. degradation of ethofumesate in the saturated zone or monitoring data).

 

  1. the active substances ethofumesate and phenmedipham and the metabolite MHPC meet the standards for per­sis­tence in soil as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).
  2. the proposed use in sugar- and fodderbeets of the product TRAMAT 500 meet the standards for leaching to shallow groundwater as laid down in the BUBG.
  3.  all proposed applications of the active substance ethofumesate 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 Regulation of Uniform Principles for Plant protection products (BUBG). This Regulation is also the legal basis for the Dutch specific criteria.

 

Ecotoxicology

 

Ethofumesate

 

 

Terrestrial Vertebrates

Acute toxicity to mammals:

LD50 > 5000 mg/kg bw (rat)

Acute toxicity to birds:

LD50 > 2000 mg/kg bw (mallard duck, quail)

Dietary toxicity to birds:

LC50 > 5200 mg/kg feed (mallard duck, quail)

NOEC = 2600 mg/kg feed

Reproductive toxicity to birds:

NOEL >406 mg/kg bw per day (>3000 mg/kg feed)

Reproductive toxicity to mammals:

NOAEL 300 mg as/kg bw, rabbit, teratogenicity, foetal

 

Aquatic Organisms

Acute toxicity fish:

LC50 = 11 mg as/l (96 h; Cyprinus carpio)

LC50 »13 mg as/l (Betanal Progress*; 96 h; Cyprinus carpio)

LC50 »26 mg as/l, based on mean measured concentration (Tramat 500; 96 h; Cyprinus carpio)

Long term toxicity fish:

NOEC = 0.8 mg as/l (21 d; Oncorhynchus mykiss)

Bioaccumulation fish:

144 (based on total radioactivity)

Acute toxicity invertebrate:

EC50 = 14 mg as/l (48 h; Daphnia magna)

EC50 » 30 mg as/l (Tramat 500; 48 h; Daphnia magna)

Chronic toxicity invertebrate:

NOEC = 0.32 mg as/l (21 d; Daphnia magna)

Acute toxicity algae:

EC50 = 3.9 mg as/l (96 h; Scenedesmus subspicatus)

EC50 = 6.7 mg as/l (Ethofumesate 50SC; 96 h; Scenedesmus subspicatus)

Chronic toxicity sediment dwelling organism:

NOEC > 5.0 mg as/l (28 d; Chironomus riparius)

Acute toxicity aquatic plants:

EC50 > 50 mg as/l (14 d; Lemna minor)

NOEC = 4.3 mg as/l (14 d; Lemna minor)

 

 

Remarks

* Betanal Progress is a formulation containing ethofumesate plus two other active substances

 

Honeybees

Acute oral toxicity:

>50 µg/bee

Acute contact toxicity:

>50 µg/bee

 

Other arthropod species

 

% Adverse effect1

Aleochora bilineata

No effects
(
adult; mortality, egg production and viability; Tramat 500; 1.25 kg as/ha)

Poecilus cupreus

No effects
(
adult; mortality; Tramat 500; 2.0 kg as/ha)

Chrysoperla carnea

No adverse effects
(larvae; mortality, egg production and viability; Tramat 500; 2 % solution, ca 2.0 kg as/ha)

Chrysoperla carnea

Slight reduction
(
larvae; mortality, egg production and viability; * Betanal Progress; 3 % solution, 0.8 kg etho­fumesate/ha)

Coccinella septempunctata

No effects
(
larvae; mortality; *Betanal Progress; 3% solution, 0.8 kg ethofumesate/ha)

Syrphus corollae

Slightly reduced performance of treated larvae
(
larvae; mortality, pupation, hatching, viable offspring; *Betanal Progress; 2 % solution)

Poecilus cupreus

No effects
(adult; mortality, number of pupae fed; *Betanal Progress; 1.5 %solution, 0.8 kg ethofumesate/ha)

Aleochora bilineata

No effects
(adult; parasitic efficiency; *Betanal Progress; 1% solution, 0.4 kg ethofumesate/ha)

Aleochora bilineata

No effects
(adult; parasitic efficiency; Ethosat; 1 % solution, 1 kg as/ha)

 

 

Remarks

* Betanal Progress is a formulation containing ethofumesate plus two other active substances

For national registration the following data are submitted:

 

Typhlodromus pyri

 

 

Aphidius rophalopsiphi

 

 

 

mortality: 2.1% at 1.0 kg as/ha
reproduction: 16% at 1.0 kg as/ha

 

mortality: -8.3% at 0.5 kg as/ha

mortality: -8.0% at 1.0 kg as/ha

reproduction: +68.3% at 0.5 kg as/ha

reproduction: 18.7% at 1.0 kg as/ha

 

(Test substance: AE B04991300 SC45A202, a.i. ethofumesate 44.7% w/w. Water miscible suspension concentrate, 500 g/L)

 

 

 

1 Adverse 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).

 

 

Earthworms

Acute toxicity:

LC50 = 134 mg/kg soil (Eisenia andrei; 14 d)

Reproductive toxicity:

NOEL > 25 mg/kg soil (Eisenia foetida; 56 d)

NOEC = 9.975 mg/kg soil (Eisenia foetida;56 d)

 

Soil micro-organisms

Nitrogen mineralization:

Max 28% inhibition 14 days after treatment with Betanal Progress at normal field rate (6.5 mg/kg) in a 60 days study. No treatment related effects in majority of studies at 4 – 20 kg as/ha.

Carbon mineralization:

Slight effect at maximum recommended field rate (2.0 mg/kg soil) in one study. No treatment related effects in majority of studies.

 

Effects on non-target flora and fauna

Effects of three co-formulations with desmedipham and phenmedipham. Weight reduction.

EC50 9 – 29 g ethofumesate/ha. Stellaria media the most sensitive species.

Effects of ethofumesate on growth of 28 species; weed and crop species, grasses and broadleaved.

Approximately half of the species were affected by more than 25% at the lowest treatment rate (63 g as/ha)

Effects of ethofumesate on non-target fauna including insects, diseases,  molluscs, endoparasites, bacteria and nematodes.

No serious effects were identified for any of the tested species.

 

Phenmedipham

Ecotoxicology

 

Terrestrial Vertebrates

 

Acute toxicity to mammals:

rat: LD50 >8000 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

Short term oral toxicity to mammals:

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

 

Aquatic Organisms

PMP

 

Species

Time scale

Endpoints

Toxicity (mg/l)

Acute toxicity fish:

Rainbow trout

96 hours

LC50

1.71

(Formulation)

Rainbow trout

96 hours

LC50

6.9

1.1 (a.i.)

Long term toxicity fish:

Rainbow trout

21 days

NOEC

0.32

Bioaccumulation fish:

Rainbow trout

64 hours

BCF

165

Acute toxicity invertebrate:

Daphnia magna

48 hours

EC50

0.41

(Formulation)

Daphnia magna

48 hours

EC50

5.7

0.9 (a.i.)

Chronic toxicity invertebrate:

Daphnia magna

21 days

NOEC

0.061

 

Daphnia magna

21 days

NOEC

0.025 (a.i.)

Acute toxicity algae:

Selenastrum capricornutum

green alga

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.)

Chronic toxicity sediment dwelling organism:

Chironomus riparius

28 days

NOEC

0.37

Acute toxicity aquatic plants:

Lemna minor

14 days

EbC50

NOEC

0.23

0.028

 

MHPC

 

Species

Time scale

Endpoint

Toxicity (mg/ l)

Acute toxicity fish:

Rainbow trout

96 hours

LC50

75

Acute toxicity invertebrate:

Daphnia magna

48 hours

EC50

14

Acute toxicity algae:

Pseudokirchneriella subcapitata 

green alga

96 hours

EbC50

 

30

 

Honeybees

 

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

 

Other arthropod species

 

 

Test species

stage

dose

Endpoint

% Adverse Effect*

 

 

Typhlodromus pyri

proto-nymphs

480 g PMP/ha

 

960 g PMP/ha

mortality

 

 

mortality

0 %

 

 

0 %

 

 

Aphidius rhopalosiphi

adults on glass plate

 

 

 

extended, adults on barley seedlings

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 %

 

 

Poecilus cupreus

adults

480 g PMP/ha

 

960 g PMP/ha

mortality

feeding activity

mortality

feeding activity

0 %

+ 15 %

 

0 %

15 %

 

 

Chrysoperla carnea

larvae

480 g PMP/ha

 

960 g PMP/ha

mortality +

fecundity mortality +

fecundity

 

12.96 %

 

6.18 %

 

 

Syrphus

corollae

larvae  development

 

4.375 %

corresp. to 2800 g PMP/ha

Mortality+

develop-ment

38 %

 

 

Coccinella

septempunctata

larvae

4.3 %

corresp. to

ca. 2800 g PMP/ha

predatory

behaviour

33 %

 

 

Erigone atra

spiders

adults

1440 g PMP/ha

mortality

behaviour

feeding

0 %

 0 %

+ 5 %

 

 

Chrysopa carnea

larvae -

development

2.25 %

corresp. to ca. 1400 g PMP/ha

mortality

development

0 %

0 %

 

 

Trichogramma cacoeciae

adults

2.25 %

corresp. to ca. 1400 g PMP/ha

parasiting

behaviour

29 %

 

 

Poecilus cupreus

adults

1430 g/ha

mortality

0 %

 

 

Bembidion lampros

adults

1440 g/ha

mortality

0 %

 

 

4 species of ground dwelling spiders

adults

0.5 %

corresp. to ca. 314 g PMP/ha

mortality

0 %

 

 

Aleochara bilineata

adults

1400 g/ha

parasiting behaviour

+ 10 %

 

* Adverse 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 beneficial / 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).

 

 



Earthworms

 

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

 -> 2.5 kg PMP/ha, corresponding to 3.33 mg a.i./kg soil (standard soil bulk density)à

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

 

 

Soil micro-organisms

 

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 were 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.

 

Endpoints product (Tramat 500)

 

Non-target arthropods

 

Species

Stage

Test

Substance

Dose

(kg/ha)

Endpoint

Adverse Effects1

Annex VI

Trigger

Laboratory tests

Aleochora bilineata

adult

Tramat 500

1.25

kg as/ha

Mortality, egg production and viability

no effects

30%

Poecilus cupreus

 

 

adult

Tramat 500

2.0 kg as/ha

Mortality

no effects

30%

Chrysoperla carnea

larvae

Tramat 500

2% solution

ca 2.0 kg as/ha

Mortality, egg production and viability

no adverse effects

30%

 

 

 

7.1       Effects on birds

Birds can be exposed to the active substance 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 M.5 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.

 

Tabel M.5 Overview of threshold values for birds

Substance

Exposure

 

Endpoint

Safety factor

Threshold value

 

 

 

[mg/kg bw/d]

 

[mg/bird/d]

ethofumesate

Acute

LD50 

> 2000

10

> 2

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Short term

LC50

> 5200

10

> 520

 

Long term

NOEC   

> 3000

5

> 600

 

 

 

 

 

 

 

 

 

[mg/kg bw/d]

 

[mg/bird/d]

phenmedipham

Acute

LD50 

> 2100

10

> 2.1

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Short term

LC50

> 20001

10

> 200

 

Long term

NOEC   

1200

5

240

1: only NOEC-values available

 

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 the 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 M.6 an overview is presented of the calculated concentrations in food.


 

Tabel M.6 Overview of concentrations in food

Application/

Use/use

Rate

RUD *

Max. freq.

PIECfood

 

[kg/ha]

 

 

[mg/kg]

sugar- and fodderbeets

ethofumesate: 0.5

phenmedipham: 0.8

25

25

1

1

12.5

20

* residue per unit dose according to Luttik

 

In table M.7, threshold exceeding factors at exposure to food and drinking water are presented.

 

Tabel M.7 Threshold exceeding factors for natural food and drinking water

Use

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

sugar- and fodderbeets

ethof: < 0.001

phen: < 0.001

combi: < 0.001

ethof: < 0.012

phen: < 0.028

combi: < 0.046

ethof: < 0.024

phen: < 0.1

combi: < 0.124

ethof: 0.021

phen: 0.09

combi: 0.106

 

Taking the results in Table M.7 into account, a low risk for birds can be expected due to foraging and drinking of surface water for the use in sugar- and fodderbeets. The proposed use meets the standards for birds 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: > 600 mg/kg food for ethofumesate and 240 mg/kg food for phenmedipham.

 

Fish

 

Ethofumesate

The BCFfish for ethofumesate is 144 L/kg. The highest PECwater(28)  (taken from paragraph 6.2.1.)  amounts 2.06 mg/L = 0.00206 mg/L for the normal application and 0.0103 mg/L for the application by aircraft.

The risk is then calculated as PECwater(28)  * BCFfish / trigger value = 0.00206* 144 / 600 = <0.001 for the normal application and 0.0025 for the application by aircraft. Since this is below 1, the risk for birds as a result of consumption of contaminated/exposed fish is considered to be small for ethofumesate.

Phenmedipham

The BCFfish for phenmedipham is 165 L/kg. The highest PECwater(28)  (taken from paragraph 6.2.1.)  amounts 0.061 mg/L = 0.000061 mg/L for the normal application and 0.00031 mg/L for the application by aircraft.

The risk is then calculated as PECwater(28)  * BCFfish / trigger value = 0.000061* 144 / 600 = < 0.001 for the normal application and <0.001 for the application by aircraft. Since this is below 1,


the risk for birds as a result of consumption of contaminated/exposed fish is considered to be small for phenmedipham.

Earthworms

 

Ethofumesate

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

The logKow of ethofumesate is 2.7, which leads to a BCFworm = 5.7 kg soil/kg worm.

The highest PECsoil(28) amounts, corrected to the soil wet weight, 0.37 mg/kg soil. 

The risk is then calculated as PECsoil(28)  * BCFworm / trigger value = 0.37* 5.7  / 600 = 0.0035. Since this is below 1, the risk for birds as a result of consumption of contaminated/exposed worms is considered to be small for ethofumesate.

 

Phenmedipham

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 = 6.72 kg soil/kg worm.

The highest PECsoil(28) amounts, corrected to the soil wet weight, 0.51 mg/kg soil. 

The risk is then calculated as PECsoil(28)  * BCFworm / trigger value = 0.51* 6.72  / 240 = 0.014. Since this is below 1, the risk for birds as a result of consumption of contaminated/exposed worms is considered to be small for phenmedipham.

 

Hence, the proposed use(s) meet(s) the standards for secondary poisoning as laid down in the BUBG.

 

Conclusions birds

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 M.8 for the active substances ethofumesate and phenmedipham. Threshold values for acute exposure are 0,01 times lowest the L(E)C50-value (daphnids and fish) and 0.1 times the lowest EC50-value for algae.

Because the application for authorisation concerns a 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 M.8 for the derivation of acute and chronic threshold values.


 

Tabel M.8 Overview toxicity endpoints and threshold values for the active substance and metabolite(s)

Substance

Organism

Lowest

Safety factor

Threshold value

 

 

L(E)C50 [mg/L]

NOEC

[mg/L]

 

[mg/L]

[mg/L]

ethofumesate

Acute

 

 

 

 

 

 

Algae

3.9

 

  10

0.39

390

 

Daphnids

14

 

100

0.14