Toelatingsnummer 10319 N

Agrichem Ethofumesaat Flowable  

 

10319 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 UITBREIDING TOELATING

 

Gelet op de aanvraag d.d. 16 augustus 2007 (20070782 UG) van

 

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

 

tot uitbreiding van de gebruiksdoeleinden van de toelating als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden, voor het gewasbeschermingsmiddel, op basis van de werkzame stof ethofumesaat

 

Agrichem Ethofumesaat Flowable

 

gelet op artikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

1.      Het gebruiksgebied van het middel Agrichem Ethofumesaat Flowable wordt met ingang van datum dezes  uitgebreid met de toepassing tekst/toepassingsgebieden. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit.

2.      De toelating geldt tot 28 februari 2013.

 

1.2  Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

 

1.3  Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.


 

1.4 Classificatie en etikettering

 

Gelet op artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

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:

 

aard van het preparaat: Suspensie concentraat

 

werkzame stof:

gehalte:

ethofumesaat

500 g/l

 

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof:  

-

 

gevaarsymbool:

aanduiding:

-

-

 

Waarschuwingszinnen: 

 

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

 

Veiligheidsaanbevelingen:

 

Draag geschikte handschoenen tijdens het mengen en laden.

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

 

Specifieke vermeldingen:

 

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

 

 

2.    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.      bij het toelatingsnummer een cirkel met daarin de aanduiding W.3.

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Agrichem Ethofumesaat Flowable (10319 N), een middel op basis van de werkzame stof ethofumesaat. Het middel is bij besluit van 23 februari 2007 toegelaten als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten. Het middel is bij dit besluit toegelaten tot 28 februari 2013. Met onderliggende aanvraag wordt toelating als onkruidbestrijdingsmiddel in de zaadteelt van Engels en Italiaans raaigras gevraagd.

 

2.2 Informatie met betrekking tot de stof

Ethofumesaat is een bestaande werkzame stof, geplaatst op Annex I per 1 maart 2003 (Dir. 2002/37/EG d.d. 3 mei 2002).

 

2.3 Karakterisering van het middel

Agrichem Ethofumesaat Flowable is een herbicide op basis van ethofumesaat. Er zijn middelen toegelaten op basis van alleen ethofumesaat als werkzame stof, maar ook 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 celmembraan 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.

 

2.4 Voorgeschiedenis

De aanvraag is op 16 augustus 2007 ontvangen; op 17 augustus 2007 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 22 november 2007 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is de Handleiding toelating bestrijdingsmiddelen (HTB) versie 1.0 (RGB H2).

 

3.1  Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).

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

 

3.2  Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuen die het gevolg zijn van geoorloofd gebruik die in toxicologisch opzicht of vanuit milieu oogpunt van belang zijn, kunnen worden bepaald met algemeen gebruikte passende methoden (artikel 28, eerste lid, sub d, Wet gewasbeschermings-middelen en biociden).

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

 


 

3.3  Risico voor de mens

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar (artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en biociden.
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.

Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij dit besluit.

 

3.4  Risico voor het milieu

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

Het profiel gedrag en lotgevallen staat beschreven in Hoofdstuk 6 in Bijlage II bij dit besluit. Het profiel Ecotoxicology staat beschreven in Hoofdstuk 7 in Bijlage II bij dit besluit.

 

3.5  Werkzaamheid

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen en biociden).

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

 

3.6  Eindconclusie

Bij gebruik volgens het gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is de uitbreiding voor de gevraagde doeleinden van 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 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden).

 


 

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden 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 gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

Wageningen, 13 juni 2008

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,



(voorzitter)

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 13 juni 2008 tot uitbreiding van de toelating 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 en in de zaadteelt van Engels en Italiaans raaigras.

 

De totale dosering in één seizoen mag niet hoger zijn dan 2 kg ethofumesaat (als werkzame stof) per hectare.

 

Toepassing met een luchtvaartuig is niet toegestaan.

 

Na gebruik in Engels en Italiaans raaigras, het gras niet vervoederen.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

Om terrestrische niet-doelwit planten te beschermen is de toepassing in de zaadteelt van Engels en Italiaans raaigras uitsluitend toegestaan indien er gebruik wordt gemaakt van een van onderstaande driftreducerende maatregelen en eventueel gerelateerde teeltvrije zone:

-           Verlaagde spuitboomhoogte (30 cm boven het gewas) met 50% driftreducerende doppen + kantdop

-           Sleepdoek spuittechniek

-           Teeltvrije zone van 1,6 meter

-           50% drift reducerende doppen in combinatie met een teeltvrije zone van 0,7 meter

-           75% drift reducerende doppen in combinatie met een teeltvrije zone van 0,6 meter

-           Bespuiting met luchtondersteuning en 50% of 75 % drift reducerende doppen en einddop

-           Bespuiting met luchtondersteuning en een teeltvrije zone van 1,0 m.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

Agrichem Ethofumesaat Flowable is een bodemherbicide met systemische werking via de ondergrondse delen van de onkruiden. Vochtige grond op het moment van toepassen en enige neerslag nadien bevorderen de werking. De gewassen moeten echter bij behandeling droog zijn. Met uitzondering van kamille bestrijdt Agrichem Ethofumesaat Flowable een breed spectrum éénjarige onkruiden waaronder kleefkruid. Waterhoeveelheid: 200-300 liter per ha.

 

Toepassing in de teelt van suiker- en voederbieten

Agrichem Ethofumesaat Flowable is na-opkomst alleen werkzaam in combinatie met middelen op basis van fenmedifam (157 of 160 g/l). Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige zaadonkruiden.

 

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


 

Dosering:

-        Vanaf het 2 bladstadium (BBCH 12) van de biet:
0,6 liter Agrichem Ethofumesaat Flowable + 3,5 liter fenmedifam per hectare.

Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,6 liter Agrichem Ethofumesaat Flowable + 3,5 liter fenmedifam per hectare. 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 + 5,0 liter fenmedifam per hectare als enkelvoudige behandeling.

 

Mengvoorschriften

Agrichem Ethofumesaat Flowable toegepast in combinatie met middelen op basis van fenmedifam:

-           Giet 20-50 liter water in de tank

-           Voeg fenmedifam toe en zet het roersysteem in werking

-           Voeg water toe tot de helft van de benodigde hoeveelheid

-           Voeg 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.

 

Restricties:

-        Spuit 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.

 

Toepassing in de zaadteelt van Engels en Italiaans raaigras

Agrichem Ethofumesaat Flowable bestrijdt duist, windhalm, straatgras, muur en herderstasje in de zaadteelt van Engels en Italiaans raaigras. Het effect op graanopslag is wisselvallig.

 

Tijdstip van toepassen:

Agrichem Ethofumesaat Flowable kan worden gespoten vanaf het moment dat het raaigras 2 spruiten heeft gevormd. Bij toepassing na de oogst van de dekvrucht dient het raaigras afgehard te zijn. Behandeling niet herhalen. Spuit op een gezond gewas.

Dosering:

-   3,0 liter per hectare, indien duist en windhalm kleiner zijn dan 3 spruiten

-   3,6 liter per hectare, indien reeds 3-5 spruiten zijn gevormd.

Grotere duist of windhalm wordt niet meer bestreden.

 

Opvolgende gewassen:
Om schade te voorkomen als gevolg van eventuele residuen van ethofumesaat in de grond moet voor het zaaien of planten eerst kerend worden geploegd, bijvoorbeeld bij een nateelt van wintergranen of bij een mislukte teelt. Bij mislukken van een gewas waarin Agrichem Ethofumesaat Flowable werd toegepast kunnen de volgende gewassen na kerend ploegen gezaaid of geplant worden: suiker- en voederbieten, maďs, bruine bonen, tuinbonen, raaigrassen, erwten, spinazie, knolselderij, wortelen, zaai- en plantuien.



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 13 juni 2008 tot uitbreiding van de toelating van het middel Agrichem Ethofumesaat Flowable, toelatingnummer 10319 N

 

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product          4

 

2.   Physical and chemical properties                    5

 

3.   Methods of analysis                                           9

 

4.   Mammalian toxicology                                       12

 

5.   Residues                                                             17

 

6.   Environmental fate and behaviour                  17

 

7.   Ecotoxicology                                                     26

 

8.   Efficacy                                                                44

 

9.   Conclusion                                                          44

 

10. Classification and labelling                              44

 


1.         Identity of the plant protection product

 

1.1       Applicant

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT

 

1.2       Identity of the active substance

ISO Common name

ethofumesate

Name in Dutch

ethofumesaat

Chemical name

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

CAS nr

26225-79-6

EEG nr

247 525-3

 

The active substance is considered to be equivalent to the active substance as included in Annex I of directive 91/414/EEC on March 1st 2003.

 

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 of 91/414/EEC.

 

1.4       Function

Herbicide.

 

1.5       Uses applied for

Uses

Dose a.s.

(g a.s./ha)

Number of applications

Interval between applications

Application time (growth stage and season)

Perennial ryegrass and Italian ryegrass (seed production)

1500-2000

1

n.a.

From BBCH 22 onwards

September-November

 

1.6       Background to the application

It concerns an extension of the authorization.

 

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 (no particular recommendations).

 

 

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 (DAR, 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 0.24 - 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.2.2.15 (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.2.2.16 (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 determinations are not reported here.

Acceptable

B.2.2.17

(IIIA 2.8)

Wettability

 

Not applicable

 

B.2.2.18 (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.2.2.19

(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%

Acceptable

B.2.2.20

(IIIA 2.8)

Spontaneity of dispersion

GLP: Y

CIPAC MT160

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

Acceptable

B.2.2.21

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.23

(IIIA 2.8)

Wet sieve test

GLP: Y

CIPAC MT59.3

Residue on a 75 μm: 0.02%

Acceptable

B.2.2.24

(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.2.2.25

(IIIA 2.8)

Content of dust/fines

 

Not applicable

 

B.2.2.26

(IIIA 2.8)

Attrition and friability

 

Not applicable

 

B.2.2.27 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable

 

B.2.2.28

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable

 

B.2.2.29

(IIIA 2.8)

Flowability

 

Not applicable

 

B.2.2.30

(IIIA 2.8)

Pourability (rinsibility)

GLP: Y

CIPAC MT148

Residue: 2.67

Rinsed residue : 0.18%

Acceptable

B.2.2.31

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.32

(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

 

Only mixing with other plant protection products containing phenmedipham (ca 160 g/L) 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

None.

 

 

3.      Methods of analysis

 

Description and data about the analytical methods concerning ethofumesate are taken from the List of Endpoints (DAR, 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 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

0.1 µg/L (HTB 1.0)

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 for water, soil and air, evaluated in the DAR, 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 monitoring of residues in the environment.

 

3.3       Data requirements

None.

 

3.4       Physical-chemical classification and labelling

 

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

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

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

 

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

 

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

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

-

-

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

Supported shelf life of the formulation: 2 years

 


 

4.      Mammalian toxicology

 

List of Endpoints

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. 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 Endpoints 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

None.

 

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

None.

 

4.2       Dermal absorption (IIIA 7.3)

NL commented on dermal absorption for ECCO76, WG-Evaluation and WG-Legislation. Based on physical chemical parameters (Mol. Weight 286, 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 Endpoints. 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

Agrichem Ethofumesaat Flowable is a SC formulation and contains 500 g/L ethofumesate.

 

The formulation Agrichem Ethofumesaat Flowable is applied by mechanical downward spraying in Perennial and Italian ryegrass. The formulation is applied once round emergence with a maximum dose of 4 L formulation / ha. Therefore, a semi-chronic exposure duration is applicable for the operator (including contract workers).

 

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 the Table below the estimated internal exposure is compared with the systemic AOEL. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

The maximum dose in the field 2 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 downward spraying on Perennial and Italian ryegrass

Mixing/

Loading

Respiratory

0.1

175

<0.01

Dermal

400

175

2.29

Application

Respiratory

0.16

175

<0.01

Dermal

60

175

0.34

 

Total

460

175

2.63

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 respiratory exposure to ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in Perennial and Italian ryegrass.

 

For the unprotected operator, adverse health effects after dermal exposure to ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in Perennial and Italian ryegrass cannot be excluded. Correct use of personal protective equipment can reduce the dermal exposure by a factor of 10. This results in a sufficient reduction of the exposure to ethofumesate for the application of Agrichem Ethofumesaat Flowable in Perennial and Italian ryegrass.

 

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 Perennial and Italian ryegrass.

 

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 Perennial and Italian ryegrass.

 

4.5       Appropriate mammalian toxicology and operator exposure endpoints relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

None.

 

4.7       Combination toxicology

Agrichem Ethofumesaat Flowable contains only one active substance and it is not described that it should be used in combination with other formulations in Perennial and Italian ryegrass.

 

4.8       Mammalian toxicology classification and labelling

 

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

 

Symbol:

-

Indication of danger: -

 

Risk phrases

-

-

 

Proposal for the classification and labelling of the formulation concerning health

 

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

 

 

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

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

S37d-NL

Wear suitable gloves during mixing and loading

 

 

 

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

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

Child-resistant fastening obligatory?

n.a.

Tactile warning of danger obligatory?

n.a.

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

Based on the operator risk assessment, S37d-NL is assigned.

Other:

The phrase DPD14 shall only be assigned to preparations not classified for physico-chemical properties, health or environmental hazards, but containing at least one substance posing health or environmental hazards. Since Agrichem ethofumesate flowable is labelled with R52/53, DPD14 should be removed from the label.

 


 

5.      Residues

 

The application for authorisation of the plant protection product Agrichem Ethofumesaat Flowable in Italian and Perennial ryegrass does not concern crops used for food or feed (use of Perennial and Italian ryegrass as well as the straws after harvest of the seeds is prohibited as livestock feed). Therefore, a further assessment of the residual behaviour of ethofumesate is not necessary. The additional risk for consumers is considered to be negligible.

 

 

6.                  Environmental fate and behaviour

 

Risk assessment is done in accordance with HTB 1.0 for products based on
- active substances which have already been placed on Annex I of directive 91/414/EEC

- “new” active substances;

for other plant protection products, HTB 0.2 applies.

This means that for the current application of Agrichem Ethofumesaat Flowable, risk assessment is done in accordance with HTB 1.0.

 

List of Endpoints Fate/behaviour 

 

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.

 

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

 

6.1       Fate and behaviour in soil

6.1.1    Persistence in soil

The Board for the authorization of plant protection products and biocides in the Netherlands (Ctgb) has to evaluate persistence in compliance with the INS[1] method. The new procedure for the assessment of persistence of plant protection products for authorization will be implemented in the near future.

 

As long as the mentioned RIVM report has not been laid down by the competent authorities, the Ctgb will fall back on the tried and tested method which has hitherto been in use for evaluating applications for the authorization of plant protection products.

 

If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS method.

 

For the current application this means the following:

 

Ethofumesate

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

 

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

 

From the results it is shown that the average field DT50 is < 90 days. Therefore, the standards for persistence are met.

 

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.

 

The following input data are used for the calculation:

 

PEC soil:

 

Active substance ethofumesate:

Maximum field DT50 for degradation in soil: 250 days

 

Molecular weight: 286.3 g/mol

 

 

See Table M.1 for other input values and results.

 

Table M.1 PECsoil calculations (5 cm )

Use

Substance

Correction factor

Rate

[kg a.s./ha]

Freq.

Fraction on soil

PIECsoil

5 cm

[mg a.s./kg]

PECsoil

21 days, wet weight

[mg a.s./kg]

ryegrass

ethofumesate

-

2

1

0.4

1.07

1.04

 

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 active substance (and metabolites) is calculated in the first tier using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate [2.0 kg/ha], the crop [grass] and an interception value appropriate to the crop of 0.6. Date of yearly application is 25/05/1901. For metabolites all available data concerning substance properties are regarded. The following input data are used for the calculation:

 

 

PEARL:

 

Ethofumesate:

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

Mean standardised field DT50 for degradation in soil: 41.8 days*

Mean Kom (pH-independent): 78 L/kg; 1/n: 0.9 (default).

 

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 the realistic worst case GAP, see Table M2a.

 

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

No./ Use

Substance

Rate substance [kg/ha]

Frequency

Interval [days]

Fraction

intercepted

PEC

groundwater [mg/L]

 

 

 

 

 

 

spring

ryegrass

ethofumesate

2.0

1

-

0.6

2.30

 

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

 

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

 

Lysimeter/field leaching studies

An extensive assessment for leaching was made in the decision of the Board d.d. 7th of March 2008. The main findings from that assessment are included here.

A lysimeter study in sugar beets has been submitted. In this lysimeter no ethofumesate was found in the leachate.

A vulnerability assessment according to the report by Verschoor et al. 2001 showed a more vulnerable soil profile compared with the Dutch standard scenario. The precipitation and irrigation is comparable. The soil temperature is higher and by that less vulnerable. No parallel studies on DT50 and Kom with the lysimeter soil are available. Nevertheless standardisation according to Verschoor was carried out. The result was a simulation error (SE) of 2 x 10-12. This value is not relevant for risk assessment because this value is too low.

 

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.

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.

 

From the final degradation and sorption studies with the lysimetersoil a lysimeter half-life of 58.8 days and a Kom value 108.4 L/kg were derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 4513, which is the correct value to use for further assessment.

 

Standardisation using the third lysimeter (grass) specific DT50 and Kom value revealed a simulation error of > 42280.

 

Simulation errors for ethofumesate were calculated for the two soil types of the three lysimeter soils. In principle the simulation errors of all lysimeters can be used for the risk assessment for deriving the adjustment factor. Nevertheless the very low simulation error is excluded because this value is not relevant for risk assessment.

Calculated values and conclusions for leaching including lysimeter data are given in Table M.2b. According to Van der Linden et al., the adjustment factor for leaching estimations in the authorisation procedure is 4513 (2 experiments, 1 number of lysimeter soils).

 

Table M.2b Expected leaching for the a.s. ethofumesate including correction based on lysimeter studies

Use

Substance

Computed target [mg/L]

Simulation Error (mean)

No. of lysimeter soils

fadjustment

Adjusted PEC

groundwater

spring (modelled target conc./fadj.) [mg/L]

ryegrass

ethofumesate

2.30

23396.5

1

4513

<0.001

 

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

 

From Table M.2b it reads that the expected leaching based on the PEARL-model calculations for the a.s. ethofumesate is smaller than 0.01 µg/L for all proposed applications. Hence, the applications meet the standards for leaching.

 

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 concerning persistence and leaching in soil.

 

6.2       Fate and behaviour in water

6.2.1    Rate and route of degradation in surface water

The exposure concentrations of the active substance ethofumesate in surface water have been 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. The following input data are used for the calculation:


 

TOXSWA:

Active substance 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

 

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. Aircraft application is not allowed.

 

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

 

Table M.3 Overview of surface water concentrations for active substance ethofumesate following spring application

No/ Use

Substance

Rate a.s.

[kg/ha]

Freq.

Inter-val

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

ryegrass

ethofumesate

2.0

1

-

1

9.52

8.56

8.27

* calculated according to TOXSWA

 

The exposure concentrations in surface water are compared to the ecotoxicological threshold values in section 7.2.

 

Monitoring data

There are no trigger data available regarding the presence of the substance ethofumesate in surface water. The substance ethofumesate is deemed not problematic.

 

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 Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’. No mathematical model for this aspect is available. This means that any data that is available cannot be adequately taken into account. It is therefore not possible to arrive at a scientifically well-founded assessment according to this criterion. The Ctgb has not been given the instruments for testing surface water from which drinking water is produced according to the drinking water criterion. In order to comply with the Court’s decision, however - from which it can be concluded that the Ctgb should make an effort to give an opinion on this point – and as provisional measure, to avoid a situation where no authorisation at all can be granted during the development of a model generation of the data necessary, the Ctgb 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 Ctgb about the product and its active substance ethofumesate, the Ctgb 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 Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water are met.

 

6.3       Fate and behaviour in air

Route and rate of degradation in air

Ethofumesate

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.

 

Since at present there is no framework to assess fate and behaviour in air of plant protection products, for the time being this issue is not taken into consideration.

 

6.4       Appropriate fate and behaviour endpoints relating to the product and approved uses

See List of Endpoints.

 

6.5       Data requirements

None.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

  1. the active substance ethofumesate meets the standards for per­sis­tence in soil.
  2. all proposed applications of the active substance ethofumesate meet the standards for leaching to the shallow groundwater.
  3. all proposed applications of the active substance ethofumesate meet the standards for surface water destined for the production of drinking water.

 

 

7.      Ecotoxicology

 

The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies from the DAR. Since the endpoints of the new studies are comparable with the endpoints from the DAR, the definitive List of Endpoints from the DAR is used for the risk assessment. Comments and additions are given in italic. Some studies and statements submitted for re-registration (the decision of the Board d.d. 23rd of February 2007) are used. Also a new study with the formulated product was submitted by the applicant (see endpoints formulation).

 

List of Endpoints Ecotoxicology

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 parameter 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.

 

Additional information provided by Agrichem (summarized and evaluated by the Ctgb, 04/2008))

Based on residue data from grass crops, included in the DAR of ethofumesate (non-protected data). Based on these residu trials, eleven studies were considered suitable for residue decline calculation and initial residual values on crop. All studies were preformed  in N-EU, with a single application of 2.0 kg a.s./ha.

 

 

trial

Residue (t = 0)

[mg a.s./kg plant]

DT50

[days]

RUD

[(mg a.s.*ha)/

(kg a.s.plant*kg a.s.)

1

159

6.52

79.6

2

257

4.31

129

3

43.6

3.57

21.8

4

205

1.93

103

5

107

10.82

53.7

6

107

2.75

83.3

7

240

3.49

120

8

121

2.16

60.5

9

168

3.51

84.3

10

223

2.05

112

11

224

3.44

112

Mean

174

4.05

87.7

Geomean

 

3.53

 

 

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

Reproduction

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 parameter 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). An additional study was submitted by the applicant. This was summarized and evaluated by the Ctgb (02/2008). This study is indicated with *.

 

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 terrestrial 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

Reproduction

17.9

+7

 

Agrichem ethofumesaat (2)

Poecilus cupreus

Lab.test

5.0

1.0

Mortality

Consumption

0

16

 

Extended lab test*

 

 

 

 

 

Agrichem ethofumesaat (2)

Typhlodromus pyri

Ext.Lab.test

5.0-20

1.0-4.0

Mortality

Reproduction

 

6.5

2.41

>4.0

 

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 parameter 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).

 

*Summarized and evaluated by the Ctgb (02/2008)

 

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.

 

7.1       Effects on birds

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

 

The threshold value for acute and short-term exposure for birds is set at 0.1 times the LD50 and LC50 value, and the threshold value for chronic exposure is set at 0.2 times the NOEC value. This means that TERs (Toxicity-Exposure Ratio’s) for acute and short-term exposure should be ł 10 and TER for chronic exposure should be ł 5.

Table E.1 presents an overview of toxicity data.

 

Table E.1 Overview of toxicity data for birds for substance ethofumesate

 

Endpoint

Value

Acute toxicity to birds:

LD50

>2000 mg a.s./kg bw

Dietary toxicity to birds:

LC50

>5200ppm ~ >1820 mg a.s./kg bw/d!

Reproductive toxicity to birds:

NOEL

406 mg a.s./kg bw/d

1 Endpoints should be expressed in daily dose. Since no data on food intake rate and body weight of the tested birds in the dietary and reproductive studies are available, the endpoints are recalculated to daily dose based on the default values as recommended in the EFSA PPR-opinion on azinphos-methyl (factor 0.35 and 0.15 for the LC50 and NOEC value resp.).

 

7.1.1    Natural food and drinking water

 

Sprayed products

Procedures for risk assessment for birds comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000).

For the current application, uses can be categorized as grassland. Depending on the crop category, different indicator species are chosen. Table E.2 shows which indicator species are relevant for which uses.

 

Table E.2. Indicator species per use

No.

Use

Crop

Indicator species

1

ryegrass

grassland

large herbivorous and insectivorous

 

Table E.3.a-c shows the estimated daily uptake values (ETE, Estimated Theoretical Exposure) of ethofumesate for acute, short-term and long-term exposure, using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a time-weighted-average factor (fTWA, only for long term) and the application rate. For uses with frequency of > 1, a MAF (Multiple Application Factor) may be applicable. The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* fTWA, only for long term].

 

Table E.3a Acute ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop (uses no.)

Indicator species

FIR / bw

RUD (90%)

MAF

Application rate (kg as/ha)

Acute ETE

(mg/kg bw/d)

Grassland

Large herbivorous bird

0.44

142

-

2.0

125

 

Insectivorous bird (small insects)