Toelatingsnummer 10319 N

 

Agrichem Ethofumesaat Flowable  

 

10319 N

 

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

BESTRIJDINGSMIDDELEN

 

1 HERREGISTRATIE EN WIJZIGING TOELATING

 

Gelet op de aanvraag d.d. 25 februari 2005 (20050073 THG) van

 

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

 

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

 

Agrichem Ethofumesaat Flowable

 

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 Agrichem Ethofumesaat Flowable 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 Agrichem Ethofumesaat Flowable, welke expireert op 28 februari 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. 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:

 

 

-

-

 

 

-          Waarschuwingszinnen:

Schadelijk 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:

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

 

Inlichtingenblad aangaande de veiligheid is voor de professionele gebruiker op aanvraag verkrijgbaar.

 

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 Flowable 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 Agrichem Ethofumesaat Flowable (10319 N), een middel op basis van de werkzame stof 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:

­        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

­        Toepassing met een luchtvaartuig is niet toegestaan

­        Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden

Tevens komt op verzoek van de toelatinghouder de toepassing in de zaadteelt van Engels en Italiaans raaigras en in grasland te vervallen.

 

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

Agrichem Ethofumesaat Flowable is een herbicide op basis 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. 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 vertraagt. 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 3 maart 2005, op 28 februari 2005 zijn de verschuldigde aanvraagkosten ontvangen. De aanvraag is op 4 augustus 2005 in behandeling genomen. De verschuldigde beoordelingskosten zijn op 5 augustus 2005 ontvangen. De aanvraag is op
13 september 2006 besproken in C-173.3.11, waarbij aanvullende gegevens gevraagd zijn voor het aspect milieu. Op 9 en 27 november 2006 zijn deze gegevens ontvangen, en op
14 december 2006 zijn de gegevens in behandeling genomen. De verschuldigde beoordelingskosten werden 15 december 2006 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 Agrichem Ethofumesaat Flowable op basis van de werkzame stof 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
Agrichem Ethofumesaat Flowable, toelatingnummer 10319 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.

 

Toepassing met een luchtvaartuig is niet toegestaan

 

Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden

 

Het middel is uitsluitend bestemd voor beroepsmatig gebruik.

 

 

B.

GEBRUIKSAANWIJZING

 

Toepassingen

Agrichem Ethofumesaat Flowable is na opkomst alleen werkzaam in combinatie met Agrichem Fenmedifam. Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige onkruiden.

Dosering:

-        Vanaf het 2 bladstadium (BBCH 12) van de biet:
0,6 liter Agrichem Ethofumesaat Flowable + 3,5 liter fenmedifam (157 g/l) in 200-250 liter water per hectare.

Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,6 liter Agrichem Ethofumesaat Flowable + 3,5 liter Agrichem 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 (BBCH 14) van de biet:
1,0 liter Agrichem Ethofumesaat Flowable + 5 liter Agrichem Fenmedifam in 250-300 liter water per hectare.

 

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

 

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.

 

N.B. Indien wintergraan nageteeld wordt, dient voor het zaaien eerste geploegd te worden om schade ten gevolge van eventuele residuen in de grond te voorkomen.

 

Mengvoorschriften

Agrichem Ethofumesaat Flowable toegepast in combinatie met Agrichem Fenmedifam:

-           Giet 20-50 liter water in de tank

-           Voeg Agrichem Fenmedifam toe en zet het roersysteem in werking

-           Voeg water toe tot de helft van de benodigde hoeveelheid

-           Voeg Agrichem Ethofumesaat Flowable toe

-           Vul verder aan met water

 

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

 

Opvolgende gewassen:
Altijd na Agrichem Ethofumesaat Flowable goed kerend ploegen alvorens opnieuw in te zaaien. Bij mislukken van een cultuurgewas waarin Agrichem Ethofumesaat Flowable werd toegepast kunnen de volgende gewassen na kerend ploegen ingezaaid worden:
suiker- en voederbieten, maďs, bruine bonen, tuinbonen, raaigrassen, witlof, erwten, spinazie, knolselderij, wortelen, zaai- en plantuien.
In deze volggewassen dan geen middelen op basis van ethofumesaat toepassen.


HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE II   RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        2

 

2.   Physical and chemical properties                  3

 

3.   Methods of analysis                                         8

 

4.   Mammalian toxicology                                      10

 

5.   Residues                                                            15

 

6.   Environmental fate and behaviour                20

 

7.   Ecotoxicology                                                    31

 

8.   Efficacy                                                               54

 

9.   Conclusion                                                        56

 

10. Classification and labelling                             56

 


1.         Identity of the plant protection product

 

1.1       Applicant

Agrichem BV

Koopvaardijweg 9

4906 CV  OOSTERHOUT

 

1.2       Identity of the active substance

ISO Ccommon name

Ethofumesate

Name in Dutch

Ethofumesaat

Chemical name

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

CAS nr

26225-79-6

EEG nr

247 525-3

 

The active substance was included on March 1st 2003 included in the Annex 1 list of from directive 91/414/EC.

 

 

1.3       Identity of the plant protection product

Name

Agrichem Ethofumesaat Flowable

Formulation type

SC

Content active substance

Ethofumesate (pure): 500 g/L (~44.2%w/w)

 

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

 

 

1.4       Function

Herbicide

 

1.5       Uses applied for

Agrichem Ethofumesaat Flowable is proposed to control a broad spectrum of annual weed, amongst them cleavers. Agrichem Ethofumesaat Flowable 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

300

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 bottle

Capacity:

1, 5 or 10L

Type of closure and size of opening:

Screw cap with induction seal

Opening:

1L bottle: 50mm

5, 10L bottles: 63mm

Other information

UN and ADR compliant

 

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/DAR, January March 2003). Changes and/or additions are taken up in italics.

Active substance (ISO Common Name)

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 (EINECS or ELINCS)

247 525-3

FAO Specification (including year of                                publication)

Not available

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

960 g/kg

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

None

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: Agrichem Ethofumesate Flowable

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

 

The range of the application concentration of the plant protection product is 0.008 - 2 %

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP: Y

Visual

Homogeneous suspension (liquid)

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP: Y

Visual

White

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP: Y

Organoleptic

Chemical

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

Theoretical assessment

Based on the chemical structure of the individual components, no explosive behaviour is expected.

Acceptable statement

B.2.2.5 (IIIA 2.2)

Oxidising properties

Theoretical assessment

Based on the chemical structure of the individual components, no oxidising behaviour is expected.

Acceptable statement

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP: Y

EC A15

470 oC

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP: Y

EC A9

> 80 oC

Acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

 

Not applicable

 

B.2.2.10 (IIIA 2.4)

pH

GLP: Y

CIPAC MT75

Undiluted product : 8.04

1% dispersion : 7.59

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP: Y

EEC A5

At 20 oC :

43 mN/m (1.08g/L dispersion in chromasolv G water)

 

No determination of an undiluted sample at 40 oC is available.

Acceptable, test outcome will not influence labelling with Xn/R65, because other triggers are not met.

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: Y

OECD 114

At 20 oC (undiluted)

Shear rates: 58.3 – 162.9 s-1

Viscosity: 99.7 – 80.2 mPa.s

 

No determination of an undiluted sample at 40 oC is available.

Acceptable, test outcome will not influence labelling with Xn/R65, because other triggers are not met.

B.2.2.13 (IIIA 2.6)

Relative density

GLP: Y

EEC A3

D420 = 1.1311

Acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable

 

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: Y

CIPAC MT 46.1.2

 

Analytical method : validated GC-FID method

CIPAC MT 148, , 59.3, 160, 161

EEC A3

 

 

GLP: Y

CIPAC MT 39.1

 

CIPAC MT 59.3, 161, 160

Stable for 2 weeks at 54 oC in HDPE packaging.

 

Before and after storage the density, wet sieve, appearance and pourability tests were performed.

 

In a second study, suspensibility and spontaneity of dispersion were also determined and found acceptable.

 

The product was stable for 7 days at 0 oC.

 

After storage wet sieve, density, suspensibility and spontaneity of dispersion were tested.

Acceptable

 

 

 

 

 

 

 

 

 

 

 

 

Acceptable

 

B.2.2.15 (IIIA 2.7)

Shelf life

GLP: Y

 

Analytical method : validated GC-FID method

CIPAC MT 75, 148, , 59.3, 160, 161, 47.2

EEC A3, A5

OECD 114, 115

Stable for 2 years in HDPE packaging at room temperature (20 oC)

 

All relevant technical properties were determined. No significant changes were observed after storage.

 

In addition to normal requirements the surface tension and viscosity were determined. These determination are not reported here.

 

Suspensibility tests were not performed at the lowest spray concentration (see B.2.2.18).

Acceptable

B.2.2.16

(IIIA 2.8)

Wettability

 

Not applicable

 

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP: Y

CAIPC MT 47.2

4 ml foam after 1 minute (2.25%v/w in CIPAC C water)

Acceptable

B.2.2.18

(IIIA 2.8)

Suspensibility

GLP: Y

CIPAC MT161

In CIPAC C water at room temperature:

0.056%v/v (0.1L/180L): 97%

2.0% (4L/200L): 98%

 

The suspensibility was not determined at the lowest spray concentration of 0.008%. However, because of the high suspensibility at 0.056% it can be assumed suspensibility at the lowest spray concentration will be in an acceptable range.

Acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

GLP: Y

CIPAC MT160

99% (5%v/v dispersion at 20 oC in CIPAC C water)

Acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Wet sieve test

GLP: Y

CIPAC MT59.3

Residue on a 75 μm: 0.02%

Acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

GLP: Y

Laser diffraction method

10% of particles < 0.78 μm

50% of particles < 2.31 μm

100% of particles < 15 μm

Acceptable (not required)

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

Not applicable

 

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

Not applicable

 

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable

 

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable

 

B.2.2.28

(IIIA 2.8)

Flowability

 

Not applicable

 

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

GLP: Y

CIPAC MT148

Residue: 2.67

Rinsed residue : 0.18%

Acceptable

B.2.2.30

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable

 

2.9.1

Physical compatibility with other products

 

Various tank mixes with Agrichem Ethofumesaat Flowable were tested. All below mentioned products form stable tank mixes.

 

The tested active substances (products) are: chloradizon (Pyramin DF, Chloradizon 430 g/L SC), phenmedipham (Betanal Flo, Phenmedipham 157 g/L SE), metamitron (Goltix).

Acceptable

2.9.2

Chemical compatibility with other products

 

See 2.9.1

Acceptable

 

No mixing with other plant protection products than the products mentioned under 2.9.1 and 2.9.2 or adjuvants is proposed. No information is available on the behaviour of this product when mixed with other products. Mixing with another product or adjuvant can therefore result in unexpected behaviour.

 

Conclusion

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

 

2.3       Data requirements

No further data requirements.

 

 


3.      Methods of analysis

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

 

The applicant has provided analytical methods and validation for the technical active substance and the plant protection product.

 

3.1.      Analytical methods in technical material and plant protection product

Technical as (principle of method)

GC-FID / GC-MS

Impurities in technical as (principle of  method)

GC-FID / GC-MS

Preparation (principle of method)

GC-FID method based on Analytical Methods for pesticides and plant growth regulators, volume X (1978)

or

HPLC-UV (225nm), which is based on CIPAC method 233

 

Conclusion

The submitted analytical methods for technical active substance and the formulation are considered acceptable.

 

3.2       Residue analytical methods

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

Not required

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

Not required

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)

Not required, non toxic compound

 

The product Agrichem Ethofumesaat (2) is used on fodder and sugar beets. No residues are expected on food/feed of plant or animal origin. Therefore, no residue analytical methods are required for crops or animal products.

 


 

Definition of the residue and proposed MRL’s for ethofumesate

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

No definition of the residue is proposed. The product is not used on or near edible crops

 

Food/feed of animal origin

No definition of the residue is proposed. No relevant residues are expected to occur in food/feed of animal origin.

 

 

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

 

The residue analytical methods, included in the abovementioned List of Endpoints, are suitable for monitoring of the MRL’s.

 

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 MRL’s and for monitoring of residues in the environment.

 

3.3       Data requirements

No further data requirements

 

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)

-

-

 

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?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

 

 

4.      Mammalian toxicology

List of End-points

 

Ethofumesate is included in Annex I of Directive 91/414/EC (Directive 2002/37/EC, 4 May 2002). Agrichem cannot refer to the protected studies from the DAR. The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies evaluated in the DAR (see Board meeting C-154.3.13, d.d. January 31, 2005 (authorisation for this formulation (Efect) was not granted, so this evaluation is not yet available on internet)). Since the endpoints of the new studies are comparable with the endpoints from the studies in the DAR, the final EU list of endpoints based on the DAR is used for the risk assessment. Therefore, the List of End Points for ethofumesate is copied from the review report  (SANCO/6507/VI/99-final, 15 May 2002). When relevant, some additional remarks/information is given in italic.

 

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 DAR 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:

1000 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 calculations4.

4 See 4.2 for comment on dermal absorption

 

Data requirements active substance

No additional data requirements are identified.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Agrichem Ethofumesaat Flowable does not need to be classified on the basis of its acute oral and dermal toxicology (based on the calculation rules described in Directive 1999/45/EG).

The formulation Agrichem Ethofumesaat Flowable does not need to be classified on the basis of its acute inhalation toxicology (no study available, not required).

The formulation Agrichem Ethofumesaat Flowable does not need to be classified for dermal irritation.

The formulation Agrichem Ethofumesaat Flowable does not need to be classified for eye irritation or skin sensitisation (based on the calculation rules described in Directive 1999/45/EG).

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

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, log Pow 2.7) and the almost complete oral absorption, the value for dermal absorption might be much higher. In the absence of data, a default value of 100% should be used according to the EU Guidance document on Dermal Absorption (Rev. 7).  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 intended uses

An application was submitted for the authorisation of the plant protection product Agrichem Ethofumesaat Flowable, a herbicide based on the active substance ethofumesate, in sugar and fodder beets. Agrichem Ethofumesaat Flowable is an SC formulation and contains 500 g/L ethofumesate. The dose to be applied is 0.6 – 1.0 L Agrichem Ethofumesaat Flowable per hectare (max. 0.5 kg/ha ethofumesate). The maximum number of applications is 2 times per season (application period May-June). Therefore, a semi-chronic exposure duration is applicable for the operator (contract workers included).

 

Calculation of the AOEL

Since ethofumesate is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 2.5 mg/kg bw/day (= 175 mg/day for a 70-kg operator), based on the 90 day study in dogs is applied (see List of Endpoints).

 

4.4.1    Operator exposure/risk

Exposure to ethofumesate  during mixing and loading and application of Agrichem Ethofumesaat Flowable is estimated with models. The exposure is estimated for the unprotected operator. In Table T.1  below the estimated internal exposure is compared with the systemic AOEL. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

The maximum dose in the field is 0.5 kg/ha ethofumesate.

 

Table T.1 Internal operator exposure to ethofumesate and risk assessment for the use of Agrichem Ethofumesaat Flowable

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical/ manual  downward on sugar and fodder beets

Mixing/

Loading

Respiratory

0.03

175

<0.01

Dermal

100

175

0.57

Application

Respiratory

0.04

175

<0.01

Dermal

15

175

0.09

 

Total

115

175

0.7

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

·       biological availability via the dermal route:   100% (see 4.2)

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

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

 

 

4.4.2    Bystander exposure/risk

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

 

4.4.3    Worker exposure/risk

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

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

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

The product complies with the Uniform Principles. 

 


Operator exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in sugar and fodder beets.

 

Bystander exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the bystander after dermal and respiratory exposure to ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in sugar and fodder beets.

 

Worker exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure to ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in sugar and fodder beets.

 

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

See List of end-points.

 

4.6       Data requirements

Based on this evaluation no additional data requirements are identified.

 

4.7       Combination toxicology

Agrichem Ethofumesaat Flowable is applied in combination with a formulation based on phenmedipham. Ethofumesate induces effects on the liver. These effects could possibly be correlated to the induction of biotransformation enzymes. The critical effect of phenmedipham is haemolytic anaemia. Based on the differences in toxicological profile, no extra risk is expected for the combined exposure to ethofumesate and phenmedipham.

 

4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification of the active ingredients (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-phrases3

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:

-

Risk phrases:

-

Safety phrases:

S36/37 is no longer assigned based on the risk assessment for the operator as performed for the re-registration of the formulation

Other:

DPD-11 is no longer assigned, as the concentration of a substance labelled with R43 does not exceed the limit of 0,1%.

 

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

 

 

5.      Residues

 

Agrichem Ethofumesaat Flowable is a liquid formulation based on 500 g/L ethofumesate. Ethofumesate is an existing active substance included in Annex I of directive 91/414/EC. The dossier is owned by the ‘ethofumesate alpha task force’.

 

Agrichem Ethofumesaat Flowable has been authorised as weed control in sugar beet and fodder beet Furthermore, Agrichem Ethofumesaat Flowable is authorised for grass seed culture and grassland, however, these applications are not defended anymore. An application request for re-registration will be evaluated below for the use on sugar- and fodder beets at a dose level of maximal`ly 2 applications of 0.6L/ha (2 x 300 g ai/ha) from the 2 leaf stage to the 4 leaf stage or 1 application of 1L/ha (500 g ai/ha) at the 4 leaf stage of the beets.

 

Agrichem is participant in the ‘ethofumesate beta task force’. It was already concluded before that the beta task force has a dossier equivalent to the EU-dossier used for Annex I inclusion, as far as the application on sugar and fodder beets concerns. Therefore, the final list of end points on residues of ethofumesate d.d.  January 25th, 2001, is used for this evaluation.

In the final review report the following restriction is assembled: the maximum amount of active substance per hectare must not exceed 1.0 kg every 3 years.

 

 

List of End-points

Residues

 

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 0.91 ppm in dairy cows and 0.89 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: ł0.1 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.

 

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

 

Comments on/additions to List of End-points

The applicant has a no letter of access to the EU-dossier. From the following studies used for Annex I inclusion data protection was claimed and granted: metabolism in ruminant, metabolism in poultry, rotational crop studies and residue trials.

 

The applicant is part of the beta ethofumesate task force with their own dossier. For the protected data from the EU-dossier of the alpha task force, the beta task force provided equivalent studies (see below).

 

5.1. Summary of residue data

 

5.1.1 Metabolism in plants

Metabolism was investigated in sugar beet, rye grass, onion, tobacco, wheat, radish and cabbage. Ethofumesate was extensively metabolised. Next to ethofumesate parent (2-Ethoxy-2,3-dihydro-3,3-dimethyl-benzofuran-5-yl-methane sulphonate), 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) were identified as major metabolites.

 

The metabolism data on sugar beet is part of the non-protected part of the EU-dossier and is sufficient for the evaluation and authorisation of the use on sugar and fodder beets.

 

5.1.2 Metabolism in animals

Metabolism was investigated in lactating goat and laying hen. Next to ethofumesate (2-Ethoxy-2,3-dihydro-3,3-dimethyl-benzofuran-5-yl-methane sulphonate), 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) were the major metabolites. Metabolism was similar in goat, hen and rat. A pig study is not required.

 

5.1.3 Residue definition (plant and animal)

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) were the main metabolites in sugar beet, rye grass, onion, tobacco, wheat, radish and cabbage.

The Working Group on Pesticide Residues of the European Commission, however, decided to include only parent 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)’ in the residue definition (voted for in the meeting of December 2002). The residue definition applies to all crops (both monitoring and risk assessment).

 

Metabolism was similar in goat, hen and rat. The Working Group on Pesticide Residues of the European Commission, however, decided to include only parent 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)’ in the residue definition (voted for in the meeting of December 2002). The residue definition applies to all animal products (both monitoring and risk assessment).

 


5.1.5 Residue data

Eight residue trials are provided by the beta task force performed in Northern Europe in 2000 and 2001. In all studies the dose level was 2 applications of 748-804 g ai/ha, which is ca. two times overdosed compared to cGAP-NL. However, since residues accounted for 8x < 0.05 mg/kg (both shoots and roots), the studies were considered acceptable.

 

5.1.6 Rotational crop studies

The beta task force provided a study on rotational crops. Bare soil was treated with 1.0 kg ethofumesate/ha. After 30 days following crops were planted: rye grass, carrot, spinach, and beans. In all plant parts low levels of ethofumesate equivalents were found. In roots ethofumesate parent was the main constituent, in other plant parts mainly metabolites of ethofumesate were found.

The results were comparable to those found in the Draft Assessment Report from the alpha task force.

Keeping in mind that the application rate (1.0 kg ai/ha compared tot maximal 600 g ai/ha/season for Agrichem Ethofumesaat Flowable) was unrealisticly high, no crop interception took place (application to bare soil) and the interval to planting the following crops was unrealisticly low (30d), expected levels of ethofumesate in following crops might be lower in practice. However, for Annex I inclusion the following restriction was set: the dose level of ethofumesate must not exceed 1.0 kg ai/ha every 3 years. With the current application request of 300-500 g ai/ha per season and normal crop rotation, this restriction will be honoured.

 

5.1.7 Livestock feeding

For the use on sugar and fodder beets only (zero residue situation), no metabolism data for livestock are required.

 

5.1.9 Calculation of the ADI and the ARfD

The ADI and ARfD were taken from the list of end points on Human Toxicology, as presented in the final review report d.d. May 15th, 2002.

 

The ADI was based on the NOAEL of 7 mg/kg bw/d from the 2y oral rat study giving rise to decreased body weight gain at the near higher dose group of 70 mg/kg bw/d. Using a safety factor of 100, the ADI was established at 0.07 mg/kg bw/d.

 

The ARfD was not allocated, since ethofumesate shows no acute toxic properties.

 

5.2 Maximum Residue Levels

EU-MRLs have been set for all requested crops by means of directives 2003/60/EC. For sugar and fodder beets, however, no MRLs have been set. Therefore, the proposal complies with the 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 and the EU-MRLs of directive 2003/60/EC. Calculation of the NTMDI shows that  1.3 % and  4.9% of the ADI is used for the general population and for children of 4-6y, respectively.

 

Risk assessment for acute exposure through diet

A calculation of the National Estimated Short Term Intake (NESTI) was not carried out since establishing an ARfD was not considered necessary.

 

 

No risk is foreseen for consumers when authorising Agrichem Ethofumesaat Flowable EC following the requested intended used with 2 applications of 0.6L/ha or 1 application of 1L/ha (300-500 g ai/ha) in fodder and sugar beet.

 

5.4 Data requirements

-

 

 

6.                  Environmental fate and behaviour

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.

 

List of Endpoints Fate/behaviour 

 

Ethofumesate is an old substance, placed on Annex I. Agrichem cannot refer to the protected studies from the monograph. The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies from the monograph. Since the endpoints of the new studies are comparable with the endpoints from the monograph, the definitive list of endpoints from the monograph is use for the risk assessment. Comments and additions are given in italic.

 

Chapter 2.5:  Fate and Behaviour in the Environment

 


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

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

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

All less than 6%

 

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

Anaerobic degradation

Not relevant because of very slow transformation

Soil photolysis

In one study: maximum conc. of NC8493 30%

 

           

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

Method of calculation

9 of 10 calculated according to 1st order kinetics,

1 of 10 calculated according to 1.5 order kinetics

Laboratory studies (range or median, with n value,

with r2 value)

DT50lab (20°C, aerobic, 40 - 75% WHC):

Range 47 – 211 days; mean 97 days;

median 84 d n=10

 

DT90lab (20°C, aerobic, 40 - 75% WHC):

Range 210 – 701 days; median 331 days; n=10

 

DT50lab (10°C, aerobic): No study

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

Results: DT50, (10°C, aerobic): 198 days.

 

DT50lab (20°C, anaerobic):

Very slow transformation: 90-100% unaltered after 60d.

 

Degradation in the saturated zone: No study

Soil photolysis

DT50, two studies:

14 d; ł290 nm, 24 h light 1.5 kg as/ha.

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

Field studies (state location, range or median with

n value)

DT50f:

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

 

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

 

California, USA: 2.1 kg as/ha: 75 days; n=1

Calculated mean of all = 77 d; median = 56 d; n=13

 

DT90f:

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 and plateau concentration

No relevant data.

Accumulation calculated based on a field DT50 = 119 days assuming 5.0 cm incorporation

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.

 

Application 1.0 kg as/ha each third year new GAP dec. 1999). There was no significant accumulation. Three years after applic. 0.1% of dose remained.

 


Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

Kd

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

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

Koc sediment

Koc = 267 and 449; mean 358, n=2

Kd  = 6.1 and 19.4; mean 12.8, n=2

 

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

Column leaching

 

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

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

Aged residues leaching

 

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

Lysimeter/ field leaching studies

 

Two studies according to BBA guideline:

 

Two lysimeters per study:

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

 

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

 

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

 

Model calculations (Annex IIA 7.2.4)   

 

Maximum/Average concentration

1)      PELMO: Two studies by two different model users (Feinchemie and AgrEvo).

Totally about 17 runs:

Varying input parameters, DT50 (50 to 114 days), Koc (99 to 207) and weather (dry to wet). Dose 1.0 to 1.25 kg as/ha applied to soil sandy soil and loamy soil, bare soil application. Date of application and crop not specified.

Great difference in result: no leaching (13 runs) to significant leaching >0.1 µg/l in 4 runs.

 

2) a) MACRO (MACRO_DB) (simulation by KemI):

Input: low dose, 0.2 kg/ha pre-emergence and highest recommended dose, 2.0 kg as/ha pre-emergence + 1.5 kg post-emergence first year. Crop all years was sugar beet. DT50  = 84 days (lab data) and log Kow = 2.7 (Koc@182). Four years simulation on a sandy loam over sand with a mean precipitation of 740 mm. Judged to be a realistic worse case scenario.

Results: Significant leaching at both recommended doses (2.0 + 1.5 kg as/ha) and at a low dose (0.2 kg as/ha).

 

b) MACRO version 4.1 (simulation by AgrEvo):

Input: 1.0 kg as/ha once per year each third year 30 days post-emergence on sugar beet. Half-life 113 days (worse case lab. data) and Koc = 157 (mean). Simulation over a period 20 x 3 years on a silty clay loam with a mean precipitation of about 648 mm. Mean temperature appr. 10°C.

 

Results: Mean concentrations calc. over periods of three years in the water passing 100-120 cm were <0.1µg/L, but highest values were close to 0.1 µg/L.

 

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

Hydrolysis of active substance and relevant metabolites (DT50) (20°C)

pH___5.0___: Negligible

 

pH___7.0___: Negligible

 

pH___9.2___: Negligible

 

Photolytic degradation of active substance and

relevant metabolites

Artificial light: (greatly variable results)

37-62d (summer, 40-60şN)

4.6 d  (on a year basis) / 2.6 d (for month May)

 

 

Readily biodegradable (yes/no)

Not readily biodegradable; n=3

Degradation in water/sediment

 

-DT50 water

 

 

- DT90 water

                           

 

- DT50 whole system

 

                           

- DT90 whole system

 

 

 

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

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

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

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

Study 1:   -

Study 2: 121 and 212 days, n=2

Study 3: -

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

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

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

Study 1: -

Study 2: 507 and 550 days, n=2

Study 3: -

Distribution in water / sediment systems (as)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Metabolites

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

 

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.

 

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

 

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

Direct photolysis in air

 

No study. 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

 

 

Definition of the Residue (Annex IIA, point 7.3)

Relevant to the environment

Soil, water and sediment: Ethofumesate

 



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

Soil (indicate location and type of study)

No data

Surface water (indicate location and type of study)

 

 

1) Monitoring area: Vemmenhög a drained catchment area with intensive agriculture, Scania, south of  Sweden :

 Samples collected during growing season, usually May to September in 1992-1998 in an open ditch receiving drainage water, 1991-1992 and at the outlet of culvert in 1992-1996.

 

Range of applied dose 1991-1996 is 0.17 to 0.30 kg as/ha in cultivation of sugar beet, covering 10 to 19% of catchment area during the period. LOD = 0.1-0.2 µg/l.

 

Reported TWMC(Time Weighted Mean Conc):

a) 1991and 1992 (open ditch): No of samples 34 and 30; frequency of detection 53 and 37%; TWMC  = 0.06 and 0.21 µg as/l, resp.

b) 1992, 1993, 1994, 1995 and 1996 (outlet of culvert): No of samples 29, 25, 18, 22 and 22; frequency of detection 97, 87, 78, 77, and 68%; TWMC  = 1.08, 0.39, 0.63, 0.14 and 0.10 µg as/l, resp.

c) 1998: Low frequency of detection and low concentration.

 

Decrease in frequency and concentrations during the sampling period has been explained by measures taken to minimise effects from bad management and surface run-off.

 

2) Monitoring area: East Anglia UK (Sugar beet growing area. A total number of 792 samples over a 5 years period.

Results: 16 samples ł0.1 µg/l; 42 samples <0.1µg/l but >LOD; LOD = 0.02-0,05 µg/l.

Remark: No details on use of as regarding dose and frequency.

 

Ground water (indicate location and type of study)

 

 

1) East Anglia, UK. A sugar beet growing region. A tot. number of 78 samples from 43 different groundwater wells over a 5 year period.

Results: 1 sample = 0.2 µg/l; 6 samples <0.1 µg/l >LOD; LOD = 0.02-0,05 µg/l.

Remark: No details on use of as regarding dose and frequency.

Air (indicate location and type of study)

No data

 

Data Fenmedifam

Since the proposed applications are only applied as a tank mix, combination toxicology with Fenmedifam has to be considered. Fenmedifam is an old substance, placed on ANNEX I since April 2004. For the risk assessment data from the final List of endpoints is used.

 

 

endpoint

Fenmedifam

soil

DT50 (days)

37

 

Komsoil (L/kg)

522

 

Komsediment (L/kg)

352

water

DT50 (days)

0.14

Vapour pressure

 

7.0x 10-10 Pa (25°C)

Solubility in water

 

0.0018 g/L (20°C)

Molar mass

g/mol

300.3 g/mol

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

 

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.

 

PECsoil

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

 

Table M.1 PECsoil calculations (5 cm )

Use

Substance

Rate

[kg a.s./ha]

Frequency

Fraction on soil

PECsoil

5 cm

[mg a.s./kg]

Beets (1)

Ethofumesate

0.3

2

0.8

0.61

 

(fenmedifam)

0.55

2

0.8

1.07

(2)

Ethofumesate

0.5

1

0.8

0.53

 

(fenmedifam)

0.785

1

0.8

0.84

 

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

 

6.1.2    Leaching to shallow groundwater

The leaching potential of the a.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 worst-case application rate [1.5 kg/ha], the crop [crop, sugarbeets] and an interception value appropriate to the crop of [0.8]. For metabolites all available data concerning substance properties are regarded. Metabolites are modelled as parent. The application rate is corrected for formation rate and molecular weight relative to the parent substance. The following input data are used for the calculation:

 

PEARL:

 

Active substance:

Mean DT50 for degradation in soil (20°C):  84 days

Mean Kom (pH-independent): 78 L/kg .

 

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

Solubility in water: 0.05 g/L (25 şC)

Molecular weight: 286.3 g/mol

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for the a.s. ethofumesate following spring applications, see Table M.2.

 

Table M.2(a) Leaching of a.s. ethofumesate as predicted by PEARL 2.2.2

Use

Substance

Rate substance

Frequency

Interval

Fraction

intercepted

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

Beets

Ethofumesate

0.3

2

10

0.8

1.56

 

 

0.5

1

-

0.8

1.25

 

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

 

From Table M.2(a) it reads that the expected leaching based on the PEARL-model calculations for the a.s. ethofumesate larger than 0.1 µg/L. Therefore, further study into the leaching behaviour is necessary.

 

In the second tier, leaching in the area of potential application is evaluated using the spatial distribution model GeoPEARL 1.1.1.

 

GeoPEARL

The leaching potential of substances to the shallow groundwater in the area of potential application within The Netherlands is calculated using the GeoPEARL model. The same input data as used in the first tier with Pearl 2.2.2. is employed. Additional input is the crop and the number of runs (plots). For results see Table M.2b.

 

Table M.2b Leaching of a.s. ethofumesate as predicted by GeoPEARL 1.1.1.

Use

Substance

Rate a.s.

Frequency

Interval

Fraction

intercepted

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

Beets (1)

Ethofumesate

0.3

2

10

0.8

1.29

(2)

 

0.5

1

-

0.8

0.99

 

GeoPEARL calculations show that the predicted leachate concentrations for ethofumesate are larger than 0.1 µg/L. Therefore, the proposed use of the active substance is not permissible. Monitoring data or a lysimeter study is required.

 

Lysimeter/field leaching studies

Agrichem has submitted a lyimeter study. In this study ethofumesate was not found in the leached water. An assessment to the vulnerability of the soil, according to Verschoor et al., (2001), the soil profile was more vulnerable than the Dutch standard soil. The amount of precipitation and irrigation was comparable. However, due to a higher soil temperature, the lysimeters were less vulnerable. Also the amount of water leached, was lower.

The lysimeter study was standardised according to Verschoor (2001). The standardisation resulted in a simulation error of 2 x 10-12. This error is irrelevant for risk assessment. Results for the PEARL calculation can therefore not be corrected for the simulation error.

 

It can be concluded that the lysimeter was not vulnerable enough for the Dutch situation. Therefore, the proposed use of the active substance is not permissible. Monitoring data or a lysimeter study comparable to the Dutch situation is required.

 

A second lysimeter study has been submitted together with a standardisation according to Verschoor (2001). Also in this lysimeter no ethofumesate was found in the leachate. However the same argumentation with regard to vulnerability as above is true. Furthermore, according to the report by Verschoor a quantitative vulnerability assessment can only be sufficient if a lysimeter study was triggered by a slight exceedance of the trigger concentration by the model calculations.

Standardisation of the lysimeters on the basis of the standard dossier data according to Verschoor revealed a simulation error of 0.75. For the lysimeter soil a preliminary sorption test was performed that resulted in a Kom value of 106 L/kg. This value can be used for the standardisation calculation. If the value is used together with the worst case DT50 value of
47 days a simulation error of  262 is calculated. If the simulation error is used as correction factor on the model results the estimated concentration in the groundwater is <0.01
mg/L.

In the lysimeters during the experiment the concentration ethofumesate was measured in the top layers of the soil. There are 3 timepoints available. From these measurements a half-life in the lysimeter topsoil can be estimated.

From these calculations a lysimeter half-life of 29.4 days was derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 14.5.

As a result the adjusted estimate for the concentration in groundwater is as reported in table M3.

 

Table M.3 Adjusted estimate leaching of a.s. ethofumesate

Use

Substance

Rate a.s.

Frequency

Interval

PEC

groundwater

 

 

[kg/ha]

 

 [days]

spring

[mg/L]

Beets (1)

Ethofumesate

0.3

2

10

0.092

(2)

 

0.5

1

-

0.07

 

The adjusted estimates show that the predicted leachate concentrations for ethofumesate are smaller than 0.1 µg/L. Hence, the active substance meets the standards laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) for the proposed applications. However, as the predicted concentration is larger than 0.01 µg/L, a restriction on the use in groundwater protection areas should be placed on the label.

 

 

Monitoring data

The notifier submitted monitoring data from groundwater monitoring from five locations in Denmark and from a regional survey in the Netherlands. Notifier submitted statements that at greater depths in none of the samples ethofumesate was detected. The original reports were not submitted. In the Danish study for most of the locations the filter depth is missing. For the Dutch survey also essential information is missing to be able to use the monitoring data in the assessment. Therefore, these are considered supplemental information.

Conclusions

The proposed application of the product complies with the requirements laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) concerning leaching to shallow groundwater. However, as the predicted concentration for ethofumesate is larger than 0.01 µg/L, a restriction on the use in groundwater protection areas should be placed on the label.

 

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 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 required (all on the basis of mean values):

 

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 şC)

Solubility in water: 0.05 g/L (25 şC)

Molecular weight: 286.3 g/mol

 

Fenmedifam:

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

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

 

Kom for suspended organic matter: 522 L/kg

Kom for sediment: 352 L/kg

 

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

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

Molecular weight: 300.3 g/mol

 

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 for each intended use are presented.

 

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

Use

Substance

Rate a.s.

[kg/ha]

Drift

[%]

PIEC [mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

 

 

 

 

Spring

spring

spring

Beets (1)

Ethofumesate

Fenmedifam

0.3

0.55

1

1

2.70

2.61

2.40

0.11

2.16

0.083

 

combination

 

 

5.31

2.51

2.24

Beets (1, aircraft application)

Ethofumesate

Fenmedifam

0.3

0.55

5

5

13.53

13.06

12.06

0.55

10.85

0.42

 

Combination

 

 

26.59

12.61

11.27

Beets (2)

Ethofumesate

Fenmedifam

0.5

0.785

1

1

2.38

3.73

2.13

0.079

2.06

0.059

 

Combination

 

 

6.11

2.21

2.12

Beets (2, aircraft application)

Ethofumesate

Fenmedifam

0.5

0.785

5

5

11.90

18.64

10.71

0.39

10.35

0.30

 

Combination

 

 

30.54

11.10

10.65

* 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 in surface water.

 


Drinking water criterion

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

 

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

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

 

The vapour pressure is 6.5 x 10-4 Pa (25 şC). The Henry constant is 6.8 x 10-4 Pa×m3×mol -1, at 25°C. The half-life in air is 2.1-4.1 hours

 

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

 

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

See List of End-points.

 

6.5       Data requirements

For the leaching of ethofumesate: monitoring data or a lysimeter study comparable to the Dutch situation.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

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

2.                  all proposed applications of ethofumesate meet the standards for leaching to shallow groundwater as laid down in the BUBG.  However, as predicted concentrations are >0.01 mg/L a label restriction is required that excludes the use in groundwater protection areas.

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.

 

List of Endpoints Ecotoxicology

 

Ethofumesate is an old substance, placed on Annex I. Agrichem cannot refer to the protected studies from the monograph. The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies from the monograph. Since the endpoints of the new studies are comparable with the endpoints from the monograph, the definitive list of endpoints from the monograph is use for the risk assessment. Comments and additions are given in italic.

 

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

Acute toxicity to mammals

LD50>8000 mg/kg bw, rat and mouse

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

Reproduction toxicity to mammals

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

Reproduction toxicity to birds

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

 

Toxicity data for aquatic species (most sensitive species of each group)

(Annex IIA, point 8.2, Annex IIIA, point 10.2)

Group

Test substance

Time-scale

Endpoint

Toxicity

(mg as/l)

Laboratory tests

Fish

 

ethofumesate

96 hours

Mortality

LC50 11

Daphnia

 

ethofumesate

48 hours

Immobilisation

EC50 14

Green algae

 

ethofumesate

96 hours

Biomass

EC50 3.9

Fish

 

Tramat 500

96 hours

Mortality

LC50 ca 13

Daphnia

 

Tramat 500

48 hours

Immobilisation

EC50 ca 30

Algae

 

Ethofumesate 50SC

96 hours

Biomass

EC50 3.2

Lemna sp

ethofumesate

14 days

Biomass

IC50 >50

NOEC 4.3

Fish

 

ethofumesate

21 days

Sublethal effects

NOEC 0.8

Daphnia

 

ethofumesate

21 days

Reproduction

NOEC 0.32

Chironomus sp

 

ethofumesate

28 days

Reproduction

NOEC>5.0

Microcosm or mesocosm tests

no data

 

 


 


Bioconcentration

Bioconcentration factor (BCF)

144, based on total radioactivity

Annex VI Trigger:for the bioconcentration factor

100

Clearance time           (CT50)

                      (CT90)

< 1 day

< 3 days

 

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

Acute oral toxicity

>50 µg/bee

Acute contact toxicity

>50 µg/bee

 

Field or semi-field tests

No significant effects of Betanal Progress (formulation with co-actives) at treatment with 6% solution (200 l/ha, 1.5 kg ethofumesate/ha) in semi-field test.

 

 

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

Species

Stage

Test

Substance

Dose

(kg/ha)

Endpoint

Adverse effect1

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%

Chrysoperla carnea

larvae

Betanal Progress

3% solution

0.8 kg etho-fumesate/ha

Mortality, egg production and viability

slight reduction

30%

Coccinella septempunctata

larvae

Betanal Progress

3% solution

0.8 kg etho-fumesate/ha

Mortality

no effects

30%

Syrphus corollae

larvae

Betanal Progress

2% solution

 

Mortality, pupation, hatching, viable offspring

slightly reduced performance of treated larvae

30%

Poecilus cupreus

 

 

adult

Betanal Progress

1.5%solution

0.8 kg etho-fumesate/ha

Mortality, number of pupae fed

no effects

30%

Aleochora bilineata

adult

Betanal Progress

1% solution

0.4 kg etho-fumesate/ha

Parasitic efficiency

no effects

 

 

Aleochora bilineata

adult

Ethosat

1 kg as /ha

Parasitic efficiency

no effects

30%

 

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).

 

Field or semi-field tests

no data

 

 

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

Acute toxicity

14 days LC50 134 mg/kg soil (Eisenia andrei)

Reproductive toxicity

56 day NOEL>25 mg as/kg soil (Eisenia foetida)

 

Effects on other soil non-target macro-organisms

No data available

-

 

 

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

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 as/ha) 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.

 

 

Agrichem ethofumesate Flowable (500 g/L SC)

Several studies with the formulated product are available. These are evaluated by the RIVM (report 10284a01, 05/2006)

 

For toxicity of the formulation to bees, non-target arthropods, earthworms and microorganisms, the applicant refers to the data for Agrichem ethofumesate (2) (evaluated by the RIVM, report 10255A00, 03/2006). From the available data it appears that the 200 EC formulation is more toxic than the 500 SC formulation, especially for non-target arthropods (see T. pyri). The data of Agrichem ethofumesate (2) can be used as worst-case formulation for present risk assessment.

 

Toxicity aquatic organisms

 

Algae

Substance

Species

Method

Duration

 

[h]

Criterion

Value

 

[mg product/L]

Value

 

[mg a.s./L]

Agrichem Ethofumesaat Flowable

Pseudokirchneriella subcapitata

static

72

ErC50

28.2

12.0

 

 

72

NOErC

1.90

0.81

 

 

72

EbC50

10.7

4.55

 

 

 

72

NOEbC

<1.90

<0.81

 

Invertebrates

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[mg/L]

Value

a.s.

[mg/L]

Agrichem Ethofumesaat Flowable

Daphnia

magna

static

48

EC50

38.3

16.3

 

Fish

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

mg/L]

Value

a.s.

[mg/L]

Agrichem Ethofumesaat Flowable

Oncorhynchus

mykiss

static

96

LC50

38.8

16.5

 

Toxicity terrestrial organisms

 

Non-target arthropods

Form.1

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects2

[%]

LR50

[kg as/ha]

Agrichem Ethofumesaat Flowable

Typhlodromus pyri

Lab.test

4

2.0

Mortality

Reproducion

0

1.0

>2.0

 

1 Formulation Agrichem Ethofumesaat Flowable = 500 g ethofumesate/L SC

 

2 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 effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

Earthworms sublethal toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem Ethofumesaat Flowable

Eisenia

fetida

10

NOEC

223.6

100

 

 

Formulation Agrichem Ethofumesaat (2) (Ethofumesate 200 g/L EC).

Several studies with the formulated product Agrichem ethofumesaat (2) are available. The studies are evaluated by the RIVM (report 10255A00, 03/2006).

 

Toxicity aquatic organisms

 

Algae

Substance

Species

Method

Duration

 

[h]

Criterion

Value

 

[mg product/L]

Value

 

[mg a.s./L]

Agrichem ethofumesaat (2)

Desmodesmus subspicatus

static

72

ErC50

39.1

8.4

 

 

 

72

NOErC

3.1

0.67

 

 

 

 

72

EbC50

41.5

8.9

 

 

 

72

NOEbC

6.25

1.34

 

Invertebrates

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[mg/L]

Value

a.s.

[mg/L]

Agrichem ethofumesaat (2)

Daphnia

magna

static

48

EC50

53.4

11.5

 

Fish

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

mg/L]

Value

a.s.

[mg/L]

Agrichem ethofumesaat (2)

Oncorhynchus

mykiss

static

96

LC50

NOEC

17.7

12.5

3.8

2.7

 

Toxicity aquatic organisms

 

(Bumble)bees

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[μg/bee]

Value

a.s.

[μg/bee]

Agrichem ethofumesaat (2)

Apis mellifera

oral

48

LD50

>488

>105

 

 

contact

96

LD50

442

95

 

Non-target arthropods

Form.1

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects2

[%]

LR50

[kg as/ha]

Agrichem ethofumesaat (2)

Typhlodromus pyri

Lab.test

10

2.0

Mortality

Reproduction

96

100

 

Agrichem ethofumesaat (2)

Typhlodromus pyri

Lab.test

0.74-3.8

0.15-0.75

Mortality

 

 

0.4

Agrichem ethofumesaat (2)

Aphidius rhopalosiphi

Lab.test

10

2.0

Mortality

Reproduction

88

65

 

Agrichem ethofumesaat (2)

Aphidius rhopalosiphi

Lab.test

1.3-13

0.25-2.6

Mortality

 

2.0

Agrichem ethofumesaat (2)

Chrysoperla carnea

Lab.test

10

2.0

Mortality

Reproducttion

17.9

+7

 

Agrichem ethofumesaat (2)

Poecilus cupreus

Lab.test

5.0

1.0

Mortality

Consumption

0

16

 

 

1 Formulation Agrichem ethofumesaat (2) = 200 g ethofumesate/L EC

 

2 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 effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

Earthworms acute toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem ethofumesaat (2)

Eisenia fetida

5

LC50

366.1

71.8

 

 

 

NOEC

131

25.7

 

Earthworms sublethal toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem ethofumesaat (2)

Eisenia fetida

5

NOECrep

90.7

17.8

 

Micro-organisms

Substance

Soil type

Dose

product

[mg/kg]

Dose

a.s

[mg/kg]

Duration

 

[d]

Process

Maximal

effect

[%]

After

...

[d]

Effect

at end

> 25%

at day 28

[Y/N]

Agrichem ethofumesaat (2)

sandy loam

2.7

13.4

9.38

46.88

28

respiration

7.0

7.4

8

1-28

N

N

Nitrification test was considered not reliable, since variation coefficient in the control was > 15% at day 7 and nitrate formation decreased after 7 and 14 days.

 

Data Phenmedipham

Since the proposed applications are only applied as a tank mix, combination toxicology with Phenmedipham has to be considered. Phenmedipham is an old substance, placed on ANNEX I since April 2004. For the risk assessment data from the final List of endpoints is used.

 


 

 

endpoints

Phenmedipham

Alga

EC50  (mg/L)

0.086

Daphnia

LC50   (mg/L)

0.41

 

NOEC  (mg/L)

0.025

Fish

LC50   (mg/L)

1.71

 

NOEC (mg/L)

0.32

 

BCF/Pow

165

Lemna

LC50  (mg/L)

0.23

Sediment organism

EC50 (mg/L)

0.37

Birds

LD50  (mg/kg bw)

>2500

 

LC50  (mg/kg)

>20001

 

NOEC (mg/kg)

1200

Mammals

LD50  (mg/kg bw)

>2000

 

NOEC (mg/kg)

100

Bees

LD50 contact (µg/bee)

50

 

LD50 oraal     (µg/bee)

>100

Non target -arthropods

See below (fragment of List of endpoint)

 

Earthworms

LC50 (mg/kg)

36

 

NOEC (mg/kg),

10.35

Microorganisms

No effects > 25% after 28 days at (mg/kg)

13

1: only NOEC-values available

 

Taken from List of Endpoints

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

Species

Stage

Test

Substance

Dose

(kg as/ha)

Endpoint

Adverse effect1

Annex VI

Trigger

Laboratory tests

Typhlodromus pyri

protonymphs

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

mortality

 

 

mortality

0 %

 

 

0 %

30 %

Aphidius rhopalosiphi

adults on glass plate

 

 

 

 

extended, adults on barley seedlings

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

 

480 g PMP/ha

 

960 g PMP/ha

mortality

 

 

mortality

 

 

mortality

fecundity

 

mortality

fecundity

63 %

 

 

43 %

 

 

7 %

+ 2 %

 

0 %

- 35 %

30 %

 

 

 

 

 

 

 

Poecilus cupreus

adults

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

mortality

feeding activity

mortality

feeding activity

0 %

+ 15 %

 

0 %

- 15 %

30 %

Chrysoperla carnea

larvae

Kemifam Flow

160 g/l

480 g PMP/ha

 

960 g PMP/ha

mortality +

fecundity

 

mortality +

fecundity

- 12.96%

 

 

- 6.18 %

30 %

Syrphus

corollae

larvae – development

 

formulation

160 g/l

4.375 %

corresp. to 2800 g PMP/ha

mortality

development

- 38 %

30 %

Coccinella

septem-punctata

larvae

formulation

160 g/l

4.3 %

corresp. to

ca. 2800 g PMP/ha

predatory

behaviour

- 33 %

30 %

Erigone atra

spiders

adults

formulation

160 g/l

1440 g PMP/ha

mortality

behaviour

feeding

  0 %

  0 %

+ 5 %

30 %

Chrysopa carnea

larvae -

development

Betanal

(157 g/l)

2.25 %

corresp. to ca. 1400 g PMP/ha

mortality

development

  0 %

  0 %

30 %

Trichogramma cacoeciae

adults

Betanal

(157 g/l)

2.25 %

corresp. to ca. 1400 g PMP/ha

parasiting

behaviour

- 29 %

30 %

Poecilus cupreus

adults

Betanal Plus (16.35 % PMP)

1430 g/ha

mortality

0 %

30 %

Bembidion lampros

adults

frame formulation

160 g/l

1440 g/ha

mortality

0 %

30 %

4 species of ground dwelling spiders

adults

Betanal

(157 g/l)

0.5 %

corresp. to ca. 314 g PMP/ha

mortality

0 %

30 %

Aleochara bilineata

adults

formulation (160 g/l)

1400 g/ha

parasiting behaviour

+ 10 %

30 %

 

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).

 

For the authorization of the formulation Efect some studies to answer the question about combined toxicity for non-target arthropods in the tankmix, the applicant (Agrichem) has submitted several studies. These studies were evaluated by Alterra (06/2006). Since the question about combined toxicity for the tankmix is the same for the re-registration of Agrichem Ethofumesaat Flowable and the applicant is the same (Agrichem), this data will also be used for this assessment.

 

Non-target arthropods

Substance

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects1

[%]

L(E)R50

[kg as/ha]

Phenmedipham

Aphidius rhopalosiphi

Ext. Lab.test

7.5

1.18

Mortality

Reproduction

5.0

9.5

>1.18

>1.18

Phenmedipham

Typhlodromus pyri

Ext. Lab. test

 

1.68

Mortality

Reproduction

9.7

>1.68

<0.142

Phenmedipham

Typhlodromus pyri

Ext. Lab. test

 

1.68

1.12

Mortality

Reproduction

12.0

33

>1.68

>1.123

 

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 effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

2 decrease in reproduction varied between 56 and 71 % over the tested range form 0.14-1.68 kg a.s./ha. No dose-response relationship could be determined. Study took 14 days.

 

3decreased reproduction in highest treatment level was 60%. No dose-response relationship could be determined.  The study took 21 days

 

7.1       Effects on birds

Birds can be exposed to the active substance ethofumesate 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 lowest LD50 and LC50 value, and the threshold value for chronic exposure is set to 0.2 times the lowest NOEC. In Table E.1 an overview of toxicity data and resulting threshold values are presented.

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

 

Table E.1 Overview of threshold values for birds

Test substance

Exposure

 

Endpoint

Safety factor

Threshold value

(0.1*LD50 target species)

 

 

 

[mg/kg bw]

 

[mg/bird]

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]

 

[mg/bird]

Phenmedipham

Acute

LD50 

>2500

10

>2.5

 

 

 

[mg/kg food]

 

[mg/kg food]

 

Short term

LC50

>2000

10

>200

 

Long term

NOEC   

1200

5

240

 

The initial concentration in food is calculated using the residu-per-unit-dose 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 highest 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 highest PIECwater.

In Table E.2 an overview is presented of the calculated worst-case concentrations of the active substance ethofumesate in food.

 

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

Use

Substance

Rate

RUD *

Max. freq.

PIECfood

 

 

[kg a.s./ha]

 

 

[mg/kg]

Beets

Ethofumesate

Phenmedipham

0.30

0.55

25

25

2

2

15

27.5

* residue per unit dose according to Luttik

 

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

 

Table E.3 Threshold exceeding factors for natural food and drinking water

Use

Substance

Threshold exceeding factors

 

 

water, acute

food, acute

food, short term

food, long term

 

 

PIEC*DWI/ 0.1*LD50target species

PIEC*DFI/ 0.1*LD50target species

PIEC/ 0.1*LC50

PIEC/ 0.2*NOEC

Beets

Ethofumesate

Phenmedipham

<0.001

<0.001

<0.022

<0.032

<0.029

<0.14

0.025

0.11

 

Combination

<0.002

<0.054

<0.17