Toelatingsnummer 12521 N

TRAMAT 500

 

12521 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 UITBREIDING TOELATING

 

Gelet op de aanvraag d.d. 24 augustus 2007 (20070825 UG) van

 

Bayer CropScience B.V.

Energieweg 1

3641 RT MIJDRECHT

 

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

 

TRAMAT 500

 

gelet opartikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1 Uitbreiding

Het gebruiksgebied van het middel TRAMAT 500 wordt met ingang van datum dezes uitgebreid met de toepassing in de veredeling en teelt van graszaadgewassen met dien verstande dat behandeld gras niet mag worden beweid of gemaaid ten behoeve van voederdoeleinden.

Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit.

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 artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer 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:

N

Milieugevaarlijk

 

Waarschuwingszinnen:

R51/53 -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

Veiligheidsaanbevelingen:

S61 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

 

Specifieke vermeldingen:

DPD01 -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:

 

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

 

         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
.

 

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

 


 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel TRAMAT 500 (12521 N), een middel op basis van de werkzame stof ethofumesaat. Het middel is bij besluit van 27 februari 2004 reeds toegelaten als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten.

Met onderliggende aanvraag wordt toelating als onkruidbestrijdingsmiddel in de zaadteelt van Engels en Italiaans raaigras gevraagd.

Het middel is bij dit besluit toegelaten tot 28 februari 2013.

 

2.2 Informatie met betrekking tot de stof

Ethofumesaat is een bestaande werkzame stof, geplaatst op Annex I van Richtlijn 91/414/EEG per 1 maart 2003 (2002/37/EG d.d. 3 mei 2002).

 

2.3 Karakterisering van het middel

Tramat 500 is een herbicide op basis van ethofumesaat. Middelen op basis van ethofumesaat zijn toegelaten met alleen ethofumesaat als werkzame stof maar ook in diverse combinaties met andere werkzame stoffen zoals 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 njarige grassen en njarige tweezaadlobbige onkruiden.

 

2.4 Voorgeschiedenis

De aanvraag is op 27 augustus 2007 ontvangen; op 30 augustus 2007 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 25 maart 2008 is de aanvraag in behandeling genomen.

 

 

3 RISICOBEOORDELINGEN

 

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2); te weten de werkinstructies RGB (voor toxicologie en milieu) en in de RGB aangeduide (delen van de) toepasselijke versie van de HTB (in dit geval versie 1.0)

 

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 gewasbeschermingsmiddelen 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.

 

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 TRAMAT 500 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, 5 november 2010

 

 

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,



dr. D. K. J. Tommel

voorzitter



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 5 november 2010 tot uitbreiding van de toelating van het middel TRAMAT 500, toelatingnummer 12521 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in:

  1. de teelt van suiker- en voederbieten;
  2. de zaadteelt van Engels en Italiaans raaigras.

 

 

Toepassing door middel van een luchtvaartuig is niet toegestaan.

 

Na gebruik in de graszaadteelt, het gras/hooi niet vervoederen.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

 

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

 

Vochtige grond op het moment van toepassen en enige neerslag nadien bevorderen de werking.

 

Niet gelijktijdig toepassen met insecticiden of fungiciden.

 

Toepassingen

 

Suiker- en voederbieten, ter bestrijding van eenjarige onkruiden.

 

TRAMAT 500 is na opkomst alleen werkzaam in combinatie met fenmedifam. Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige zaadonkruiden.
Deze combinatie komt vooral in aanmerking voor toepassing op zand- en dalgronden en specifiek voor de bestrijding van veelknopigen en kleefkruid op alle grondsoorten.

 

Doseringen:

 

Doseringen zijn afhankelijk van het gewasstadium:

         vanaf het 2-bladstadium van de biet:
Dosering:
0,3 liter middel per hectare + 2 liter fenmedifam per hectare in 200-250 liter water per hectare.
Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,3 liter middel per hectare + 2 liter fenmedifam per hectare

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

 

         vanaf het 4-bladstadium:

Dosering: 1 liter middel per hectare + 5 liter fenmedifam per hectare in 250-300 liter

water per hectare

Restricties

         spuit alleen op een afgehard en gezond bietengewas;

         spuit niet op bieten die zijn verzwakt door insecten, stuifschade, nachtvorst of herbiciden;

         spuit niet bij maximale dagtemperaturen boven 18C en niet bij scherp, zonnig weer; in deze gevallen bij voorkeur s avonds spuiten.

 

Mengvoorschrift

         giet 20-50 liter water in de tank;

         voeg fenmedifam toe en zet het roersysteem in werking;

         voeg water toe tot de helft van de benodigde hoeveelheid;

         voeg TRAMAT 500 toe;

         vul verder aan met water;

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

 

 

Zaadteelt van Engels en Italiaans raaigras, ter bestrijding van duist, windhalm, straatgras, muur en herderstasje.

 

TRAMAT 500 kan worden toegepast vanaf het moment dat het gewas 2 spruiten heeft gevormd. Bij toepassing na de oogst van de dekvrucht dient het gewas te zijn afgehard. Het effect op graanopslag is wisselvallig. Behandeling niet herhalen. Spuit op een gezond gewas.

 

Doseringen:

         3 liter middel per hectare tegen duist en windhalm met minder dan 3 spruiten

         3,5 liter middel per hectare tegen duist en windhalm met 3-5 spruiten

Grote duist en windhalm wordt niet meer bestreden.

 

Bijzonderheden

         In een normale vruchtopvolging zijn er geen beperkingen ten aanzien van volggewassen. Wel dient altijd een kerende grondbewerking te worden uitgevoerd alvorens volggewassen kunnen worden verbouwd.

 

         Bij mislukken van een cultuurgewas waarin TRAMAT 500 werd toegepast kunnen de volgende gewassen na kerend ploegen worden gezaaid of geplant: suiker- en voederbieten, mas, bruine bonen, tuinbonen, raaigrassen, witlof, erwten, spinazie, knolselderij, wortelen, zaai- en plantuien. In deze vervanggewassen dan geen middelen op basis van ethofumesaat toepassen.

 

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

 

         Waterhoeveelheid:

  • 200-300 liter water per hectare bij toepassing in de zaadteelt van Engels en Italiaans raaigras.


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 5 november 2010 tot uitbreiding van de toelating van het middel TRAMAT 500, toelatingnummer 12521 N

 

RISKMANAGEMENT

 

 

Contents Page

 

 

1. Identity of the plant protection product 3

 

2. Physical and chemical properties 3

 

3. Methods of analysis 9

 

4. Mammalian toxicology 11

 

5. Residues 17

 

6. Environmental fate and behaviour 17

 

7. Ecotoxicology 28

 

8. Efficacy 44

 

9. Conclusion 46

 

10. Classification and labelling 46

 


1. Identity of the plant protection product

 

1.1 Applicant

Bayer CropScience B.V.

Energieweg 1

3641 RT MIJDRECHT

 

1.2 Identity of the active substance

Common name

Ethofumesate

Name in Dutch

Ethofumesaat

Chemical name

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

CAS no

26225-79-6

EC no

247-525-3

 

The active substance was included in Annex I of Directive 91/414/EEC on March 1st, 2003.

 

1.3 Identity of the plant protection product

Name

Tramat 500

Formulation type

SC

Content active substance

500 g/L

 

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

 

1.4 Function

Tramat 500 SC is a herbicide.

 

1.5 Uses applied for

Extension of use is applied for the use in grass seed production. See the GAP in Appendix I.

 

1.6 Background to the application

The application aims for an extension to the use in grass seed production.

 

1.7 Packaging details

Material:

HDPE

Capacity:

0.25 - 10 L

Type of closure and size of opening:

Type: Injection moulded with induction sealing disc.

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

Other information

UN/ADR compliant.

 

 

2.                 Physical and chemical properties

 

2.1              Active substance: ethofumesate

Data on the identity and the physical and chemical properties is taken from the List of Endpoints (DAR, March 2003). Changes and/or additions are taken up in italics.

 

Identity

Common name (ISO)

Ethofumesate

Chemical name (IUPAC)

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

Chemical name (CA)

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

CIPAC No

233

CAS No

26225-79-6

EEC No

247 525-3

FAO SPECIFICATION

Not available

Minimum purity

960 g/kg

Molecular formula

C13H18O5S

Molecular mass

286.3

Structural formula

 

 

 

Physical-chemical properties

Melting point (state purity)

69.6-70.7 C (99.9 %)

Boiling point (state purity)

ethofumesate decomposes before reaching the boiling point

Temperature of decomposition

(DSC), 285 C

(TGA), 224C

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

 

Henrys law constant (in Pam3mol-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 20.00.5C

pH 7.7: 50 mg/l at 25.00.5C

pH 7.7: 57 mg/l at 30.00.5C

Solubility in organic solvents (in g/l or

mg/l, state temperature)

acetone, dichloromethane, dimethylsulphoxide,

ethyl acetate > 600 g/l at 25C

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

methanol 120-150 g/l at 25C

ethanol 60-75 g/l at 25C

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 (35C): 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 (35C and 36 days): stable to hydrolysis

-pH 9 (25C 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 40N to 60N in Europe

 

4.6 d: whole year - central Europe

2.6 d: for month May

 

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

Quantum yield of direct photo-

transformation in water at λ > 290 nm

9.5 11 x 10-5

Photochemical oxidative degradation in air

2.1 h Atkinson

4.1 h Atkinson

Flammability

Not flammable (method A10 and A12)

Auto-flammability

Not auto-flammable (method A16)

Does not self-ignite at RT (method A13)

Oxidative properties

Not oxidising (statement based on chemical structure)

Explosive properties

Not explosive (method A14)

 

2.2              Plant protection product: Tramat 500

Data on the plant protection product is based on reports of studies with Nortron 50SC. The applicant stated that Nortron 50 SC is another trade name for Tramat 500.

 

The existing range of the in-use concentrations of the plant protection product is 0.12 - 0.4%. For this application for us as grass seed treatment, the range is 0.66% to 1.75%.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP: no

Method: visual

viscous liquid

acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP: no

Method: visual

beige to greyish

Munsell colour 2.5 Y 7/2

acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP: no

Method: olfactory

aromatic

acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP: yes

EEC A.14

not sensitive to shock, not explosive when heated

acceptable

B.2.2.5 (IIIA 2.2)

Oxidizing properties

GLP: no

expert statement

no oxidizing properties

acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

not applicable for a liquid

acceptable

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP: yes

EEC A.15

auto-ignition temperature 475C

acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP: yes

EEC A.9

no flash point up to 100C

acceptable

B.2.2.9 (IIIA 2.4)

Acidity/

alkalinity

 

not applicable (4 pH 10)

acceptable

B.2.2.10 (IIIA 2.4)

pH

GLP: yes

CIPAC MT 75.3

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

Acceptable

 

The pH of the neat product should have been determined. However, as the 1% dilution has a pH very close to 7, it is not expected that the undiluted product has a pH of 4 or lower.

B.2.2.11 (IIIA 2.5)

Surface tension

GLP: yes

EEC A.5

At 40C, undiluted product:

41.7 mN/m

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

OPPTS 830.1700

dynamic viscosity

shear rate

(s-1)

viscosity at 20C

(mPa.s)

viscosity at 40C

(mPa.s)

100

-

92

20

-

261

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

OPPTS 830.1700, calculated from dynamic viscosity and density

kinematic viscosity

shear rate

(s-1)

viscosity at 20C

(mm2.s-1)

viscosity at 40C

(mm2.s-1)

100

-

82

20

-

233

acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP: yes

OECD 109

Density: 1.13 g/cm3 at 20C

acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

not relevant for a liquid

acceptable

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

CIPAC MT 46

In 1 L HDPE bottle:

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

acceptable

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

CIPAC MT 39

Stable for 7 days at 0C.

acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

GLP: no

In 1 L HDPE bottle:

Physically and chemically stable for two years at ambient temperature.

acceptable

B.2.2.16

(IIIA 2.8)

Wettability

 

not relevant for a liquid

acceptable

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP: no

CIPAC MT 47.2

0.1%, CIPAC D water:

29 mL after 1 min.

1%, CIPAC D water:

8 mL after 1 min.

acceptable

 

The new application on grass seed has a higher in-use concentration of 1.75%. Judging the two measurements at 0.1% and 1%, it is not expected that foaming will exceed 60 mL after 1 minute at a concentration of 1.75%.

B.2.2.18

(IIIA 2.8)

Suspensibility

GLP: no

CIPAC MT 161

 

 

At 30C in CIPAC D water:

98% at 0.4%, 98% at 2.0%

 

 

 

 

acceptable

 

 

GLP:no

CIPAC MT184

0.12% (0.3g in 250ml) in CIPAC D water: 99%

acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

GLP: no

CIPAC MT 160

95% in CIPAC D water

acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

 

not relevant for a liquid

acceptable

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

not relevant for a liquid

acceptable

B.2.2.22

(IIIA 2.8)

Wet sieve test

GLP: no

CIPAC MT 167

no residue on 75 m sieve

acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

 

not relevant for a liquid

acceptable

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

not relevant for a liquid

acceptable

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

not relevant for a liquid

acceptable

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

not relevant for a liquid

acceptable

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

not relevant for a liquid

acceptable

B.2.2.28

(IIIA 2.8)

Flowability

 

not relevant for a liquid

acceptable

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

GLP: no

CIPAC MT 148

residue 2.60%, rinsed residue 0.17%

acceptable

B.2.2.30

(IIIA 2.8)

Dustability

 

not relevant for a liquid

acceptable

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

not relevant for a liquid

acceptable

2.9.1

Physical compatibility with other products

GLP: no

in-house method

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

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

 

2.9.2

Chemical compatibility with other products

 

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

Acceptable;

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

 

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


 

Conclusion

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

 

2.3 Data requirements

None.

 

 

3.                 Methods of analysis

 

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

 

3.1. Analytical methods in technical material and plant protection product

Technical as (principle of method)

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

Impurities in technical as (principle of method)

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

Preparation (principle of method)

HPLC-UV with internal standard

 

Conclusion

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

 

3.2 Residue analytical methods

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

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

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

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

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

Soil (principle of method and LOQ)

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

Water (principle of method and LOQ)

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

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

Air (principle of method and LOQ)

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

Body fluids and tissues (principle of method and LOQ)

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

 

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

 

Definition of the residue and proposed MRLs for ethofumesate

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

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

Grass seed: not used for human consumption.

not applicable

Food/feed of animal origin

No residues are expected (grass is not used as animal feed).

not required

 

Required LOQ

Soil

Ethofumesate

0.05 mg/kg

Drinking water

Ethofumesate

0.1 g/L (Dutch drinking water guideline)

Surface water

Ethofumesate

0.1 g/L

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.

 

Residue analytical methods are available but not required for the proposed use on sugar and fodder beet, nor for the additional use in grass seed, since this use is not anticipated to produce residues in plant and animal products for human consumption.

 

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

 

Conclusion

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

 

3.3 Data requirements

None.


 

3.4 Physical-chemical classification and labelling

 

Proposal for the classification of ethofumesate (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

 

Regarding the physical and chemical properties of the formulation, the method of application and the further information on the plant protection product, 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?

N.a.

Tactile warning of danger obligatory?

N.a.

 

Explanation:

Hazard symbol:

 

Risk phrases:

 

Safety phrases:

 

Other:

 

 

Supported shelf-life: 2 years in HDPE.

 

The proposed labelling above is equal to the previous decision regarding the labelling of the plant protection product Tramat 500 (re-registration, dated February 23rd, 2007).

 

 

4.                 Mammalian toxicology

 

List of Endpoints

Ethofumesate is an existing substance and included in Annex I of Directive 91/414/EEC.The final List of Endpoints for ethofumesate is copied from the review report (SANCO/6507/VI/99-final, 15 May 2002). NL remarks are presented in italics.

 

Absorption, distribution, excretion and metabolism in mammals

Rate and extent of absorption:

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

Distribution:

Widely distributed.

Potential for accumulation:

No evidence of accumulation

Rate and extent of excretion:

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

Toxicologically significant compounds:

Parent compound and metabolites

Metabolism in animals:

Extensively metabolised. Hydrolysis, oxidation and ring opening.

 

 

Acute toxicity

Rat LD50 oral:

> 5 000 mg/kg bw

Rat LD50 dermal:

> 2 000 mg/kg bw

Rat LC50 inhalation:

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

Skin irritation:

Non-irritant.

Eye irritation:

Non-irritant.

Skin sensitization (test method used and result):

Non-sensitising (M&K, Buehler).

1 In the 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:

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

Lowest relevant inhalation NOAEL / NOEL:

Data not required.

 

 

Genotoxicity

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

 

 

Long term toxicity and carcinogenicity

Target / critical effect:

Liver

Lowest relevant NOAEL:

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

Carcinogenicity:

No carcinogenic potential

 

Reproductive toxicity

Target / critical effect - Reproduction:

Decreased pup weight at parental toxic dose levels

Lowest relevant reproductive NOAEL / NOEL:

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

Target / critical effect - Developmental toxicity:

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

Lowest relevant developmental NOAEL / NOEL:

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

2 Also parental NOAEL

3 Also maternal NOAEL

 

Delayed neurotoxicity

Data not required. No indication from other studies.

 

 

Other toxicological studies

Data not required.

 

 

Medical data

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

 

Summary

 

 

Value

Study

Safety factor

ADI:

0.07 mg/kg bw/d

2-y rat (Suresh‑95)

100

AOEL systemic:

2.5 mg/kg bw/d

90-d dog (Brownlie-94)

100

ARfD (acute reference dose):

Not required

 

 

 

 

Dermal absorption

No data. Default value of 10% is used for calculations4.

4 See 4.2 for comment on dermal absorption

 

 

Local effects

Ethofumesate does not produce local effects, neither after a single nor repeated exposure.

 

Data requirements active substance

None.

 

4.1 Toxicity of the formulated product (IIIA 7.1)

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

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

 

4.1.1 Data requirements formulated product

None.

 

4.2 Dermal absorption (IIIA 7.3)

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


 

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

None of the other formulants raise concerns that have not been addressed in the submitted studies.

 

4.4 Exposure/risk assessments

Overview of the intended uses

An application has been submitted for the extension of the authorisation of the plant protection product Tramat 500, a herbicide based on the active substance ethofumesate.

 

Tramat 500 is a SC formulation and contains 500 g/L ethofumesate.

 

The intended uses are listed under 1.5.

 

4.4.1 Operator exposure/risk

According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:

Tier 1: Risk assessment using the EU-AOEL without the use of PPE

Tier 2: Risk assessment using the NL-AOEL without the use of PPE

Tier 3: Refinement of the risk assessment using new dermal absorption data

Tier 4: Prescription of PPE

 

Tier 1

Calculation of the EU-AOEL / Tolerable Limit Value (TLV)

For ethofumesate no TLV has been set. The AOEL will be used for the risk assessment.

The formulation is applied once with a maximum dose of 3.5 L formulation / ha. Therefore, a semi-chronic exposure duration is applicable for the operator (including contract workers).

 

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).

 

Exposure to ethofumesate during mixing and loading and application of Tramat 500 is estimated with models. The exposure is estimated for the unprotected operator. In 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.

In the Table below the estimated internal exposure is compared with the systemic EU-AOEL. The exposure is only estimated with the highest dose.


 

Table T.1 Internal operator exposure to ethofumesate and risk assessment for the use of Tramat 500

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on grass seed

Mixing/

Loading

Respiratory

0.09

175

<0.01

Dermal

350

175

2.0

Application

Respiratory

0.14

175

<0.01

Dermal

52.5

175

0.3

 

Total

402.7

175

2.3

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.

 

Since the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL.

 

Tier 2

Calculation of the NL-AOEL

The risk index calculated with the EU-AOEL is >1. Therefore, the Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL based on allometric extrapolation (known as the NL-AOEL). This method takes into account the caloric demand of the species studied and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied.

 

The calculation of the systemic AOEL for semi-chronic exposure is based on the overall NOAEL of 350 mg/kg bw/day in the short term studies with the rat (including the multigeneratition studies). Calculations from other studies result in higher AOELs.

Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

 

Used factors are:

       extrapolation rat human on basis of caloric demand 4

       other interspecies differences: 3

       intraspecies differences: (professional use) 3

       biological availability via oral route: 100%*

       weight of professional operator/worker: 70 kg

* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption.

 

AOELsystemic: 350 x 70 / (4 x 3 x 3) =681 mg/day


 

Table T.2 Internal operator exposure to ethofumesate and risk assessment for the use of Tramat 500

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on grass seed

Mixing/

Loading

Respiratory

0.09

681

<0.01

Dermal

350

681

0.5

Application

Respiratory

0.14

681

<0.01

Dermal

52.5

681

0.08

 

Total

402.7

681

0.6

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.

 

Since the NL-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.

 

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

Re-entry activities in these crops are normally performed by tractor mounted devices and therefore, no worker exposure is expected.

 

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 Tramat 500 in grass seed.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to ethofumesate during application of Tramat 500 in grass seed.

 

Worker exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in grass seed due to exposure to ethofumesate after application of Tramat 500.

 

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

Tramat 500 contains only one active substance and it is not described that it should be used in combination with other formulations.

 

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 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

-

-

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:

-

Other:

-

 

 

5.                 Residues

 

The application for the extension of authorisation of the plant protection product Tramat 500 does not concern crops used for food or feed (a feeding restriction is applicable for grass from grass seed production). Therefore, an assessment of the residual behaviour of ethofumesate is not necessary. The risk for consumers is considered to be negligible.

 

 

6.                 Environmental fate and behaviour

 

For the current application of Tramat 500, risk assessment is performed in accordance with Chapter 2 of the RGB.

 

Ethofumesate is an existing substance, listed on Annex I of Guideline 91/414/EEC since 1st March 2003 (2002/37/EC d.d. 4th May 2002). For the risk assessment the final List of Endpoints d.d. 26th February 2002 is used. The current risk assessment is based on the decision on the re-registration of Tramat 500 (C-178.3.5) d.d. 14th Februari 2007.

 

Ethofumesate

Fate and behaviour in the environment

Fate and behaviour in soil

Route of degradation

 

Aerobic:

 

Mineralization after 100 days:

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

Non-extractable residues after 100 days:

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

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

All less than 6%

 

 

Supplemental studies

 

Anaerobic:

Not relevant because of very slow transformation

 

 

Soil photolysis:

DT50 two studies :

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

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

 

 

Remarks:

None

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 C, aerobic):

40 - 75% WHC:

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

DT90lab (20 C, aerobic):

40 - 75% WHC:

range 210 701 d; median 331 d; n=10

DT50lab (10 C, aerobic):

No study.

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

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

DT50lab (20 C, anaerobic):

Very slow transformation: 90-100% unaltered

after 60 d; n=2

 

Field studies (country or region)

 

DT50f from soil dissipation studies:

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

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

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

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

n=13

DT90f from soil dissipation studies:

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

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

Soil accumulation studies:

No relevant data.

Calculated based on a field DT50 = 119 days

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

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

Soil residue studies:

Data not required.

 

 

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

 

None.

 


Adsorption/desorption

 

Kf / Koc:

 

Kd

 

pH dependence:

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

 

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

 

Not pH dependent.

 

In the official List of Endpoints for ethofumesate there is an error. The mean Koc has been incorrectly calculated. The mean value should read 157 L/kg and not 147 L/kg.

 

The relevant part of Table 7.2.6 from volume 3 of the DAR is reproduced below:

 

Extract from Ethofumesate DAR

Table 7.2.6. Summary of results from studies concerning mobility of ethofumesate in soil. Lysimeter studies and monitoring data not included.

 

Reference

Soil

Test conc.

(mg as/l)

Koc

 

 

ADSORPTION/DESORPTION STUDIES

Bruhl, 1984

sandy loam

0.041 - 4.7

97

 

 

Allen, 1988

sand

sandy loam

silt loam

clay

0.016 - 10.5

208

124

166

126

 

 

Cameron et al, 1991

sand

sandy loam

sandy loam

0.04 - 5

205

132

116

 

 

Klein et al, 1990

podsol

parabraunerde

light sand

5.0

245

99

204

 

 

Vonk et al, 1988

sediment 1

sediment 2

0.005 - 0.04

449

267

 

 

 

1/n values were not reported in the DAR but are available from the individual reports (see Table below for full details).

 

Summary of Adsorption data of ethofumesate

Soil Texture

% Organic
Carbon

pH

1/n

Koc

Reference

Sandy loam

1.16

6.0

0.84

97

Bruhl, 1984

Sand

0.35

6.8

0.87

208

Allen, 1988

Sandy loam

1.9

7.4

0.93

124

Silty clay loam

3.2

6.65

0.89

166

Clay

4.9

6.6

0.82

126

Sand

1.12

4.6

0.88

205

Cameron et al., 1991

Acidic sandy loam

1.45

5.7

0.89

132

Alkaline sandy loam

1.66

7.3

0.87

116

Podsol

1.5

6.1

0.96

245

Mller, 1990*

Parabraunerde

1.1

7.6

0.91

99

Light sand

1.5

6.7

0.94

204

Arithmetic mean:

 

0.89

157

 

* Incorrectly referenced in DAR Table above, but refers to the same data

 

The mean values for Koc and 1/n should be used as the input data for the modelling of ethofumesate.

 

Leaching to Shallow groundwater

Ethofumesate PEARL Input Data

 

Mean Kom is incorrect the correct figure is 91 L/kg (157 / 1.72) [even considering the incorrect mean Koc = 147 the value is not 78 but 85]

 

Mean 1/n 0.89 should be used instead of the default.

 

Mobility

 

Laboratory studies:

 

Column leaching:

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

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

Aged residue leaching:

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

 

 

Field studies:

 

Lysimeter/Field leaching studies:

Two studies according to BBA guideline:

 

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

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

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

 

 

Remarks:

None.

 

Fate and behaviour in water

Abiotic degradation

 

Hydrolytic degradation:

pH 5.0, 7.0, 9.2: Negligible

Major metabolites:

None.

Photolytic degradation:

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

Major metabolites:

None identified.

 

 

Biological degradation

 

Readily biodegradable:

Not readily biodegradable; n=3

Water/sediment study:

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

DT50 water:

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

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

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

DT90 water:

Study 1: -

Study 2: 121 and 212 days, n=2

Study 3: -

DT50 whole system:

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

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

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

DT90 whole system:

Study 1: -

Study 2: 507 and 550 days, n=2

Study 3: -

Distribution in water / sediment systems
(active substance)

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

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

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

Distribution in water / sediment systems
(metabolites)

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

Accumulation in water and/or sediment:

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

Rate of mineralisation

 

Non-extractable residues

6-9%

 

27%

Degradation in the saturated zone

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

 

 

Remarks:

None.

 

Fate and behaviour in air

Volatility

 

Vapour pressure:

6.5 x 10-4 Pa (25 C)

Henry's law constant:

6.8 x 10-4 Pam3mol -1 (25 C)

 

 

Photolytic degradation

 

Direct photolysis in air:

Data not required.

Photochemical oxidative degradation in air

DT50:

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

4.1 h, calc. According to Atkinson

Volatilisation:

From plant surfaces:

22% lost from plant surface during 24 hours

From soil:

15% lost from soil surface during the first 24 hours

 

 

 

 

Remarks:

No remarks.

 

6.1 Fate and behaviour in soil

6.1.1 Persistence in soil

Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion persistence. 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[1] method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM[2]-report 601782001/2007[3].

 

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.

 

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.

 

The following input data are used for the calculation:

 

PEC soil:

 

Active substance:

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 (and 20 cm))

Use

Substance

Correction factor

Rate

[kg a.s./ha]

Freq.

Fraction on soil

PIECsoil

5 cm

[mg a.s./kg]

PECsoil

21 days,

[mg a.s./kg]

Grass seed

Ethofumesate

-

1.75

1

0.8

1.867

1.813

 

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

 

6.1.2        Leaching to shallow groundwater

Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater.

The leaching potential of the active substance is calculated in the first tier using Pearl 2.2.2. and the FOCUS Kremsmnster scenario. Input variables are the actual worst-case application rate 1.75 kg/ha, the crop grass seed and an interception value appropriate to the crop of 0,2; default fraction on soil since only the BBCH code for the development stage of the weeds is given and therefore the development stage of the crop is unknown. First date of yearly application is 15/10/1901. For metabolites all available data concerning substance properties are regarded. No metabolites occurred above > 10 % of AR, > 5 % of AR at two consecutive sample points or had an increasing tendency. The following input data are used for the calculation:

 

PEARL:

 

Ethofumesate:

Geometric mean DT50 for degradation in soil (20C): 41.8 days (range 5.9 - 193 days)*

Median Kom (pH-independent): 91 L/kg (range 57-144 L/kg) .

 1/n: 0.89 (arithmetic mean)

 

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

Solubility in water: 0.05 g/L (25 C)

Molecular weight: 286.3 g/mol

 

Other parameters: standard settings of PEARL 2.2.2

 

* See the groundwater assessment in C-178.3.5.

 

The following concentrations are predicted for the a.s. ethofumesate following the realistic worst case GAP, see Table M.2 .

 

Table M.2 Leaching of a.s. ethofumesate as predicted by PEARL 2.2.2 using normalised field DT50 values

No./ Use

Substance

Rate substance [kg/ha]

Frequency

Interval [days]

Fraction

intercepted

PEC

groundwater [mg/L]

 

 

 

 

 

 

spring

autumn

Grass seed

Ethofumesate

1.75

1

-

0.2

 

0.047

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

 

From Table M.2 it reads that the expected leaching based on the PEARL-model calculations for the a.s. ethofumesate is larger than 0.01 g/L but smaller than 0.1 g/L. The applications meet the standards for leaching. However, as the predicted concentration for ethofumesate is larger than 0.01 g/L, a restriction on the use in groundwater protection areas should be placed on the label.

Therefore, further study into the leaching behaviour is necessary.

 

Lysimeter/field leaching studies

Lysimeterstudies

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

This standardisation has been performed. For this standardisation the percolate concentration has been put on 0.0049 g/L, just below the detection limit, to be able to calculate the cumulative leaching from the lysimeter. Because there are no DT50 and Kom values for the lysimeter soil available, worst-case values have been used (lowest DT50 value and the highest Kom-value). The simulation fault (SE) is calculated by Slysi/Mlysi, the simulated leaching divided by the measured leaching. For the lysimeters simulation faults are calculated of 11 and 9.1 (mean 10.05). According to Van der Linden et al, 2004 the correction factor is calculated to be 2.226 the corrected maximum calculated concentration in the groundwater is 0.0022 g/L. This value is lower than 0.01 g/L and therefore it can be concluded that the standards for leaching to groundwater are met.

 

Monitoring data

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

 

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

 

GeoPEARL

The leaching potential of substances to the shallow groundwater in the potential area of use 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 grass seed and the number of plots (minimum 250). Calculated concentrations are corrected based on the lysimeter study. For results see Table M.3.

 

Table M.3 Leaching of a.s. ethofumesate as predicted by GeoPEARL 1.1.1. including correction based on lysimeter studies

Use

Substance

Rate a.s. [g/ha]

Frequency

Fraction

intercepted

PEC

groundwater [mg/L]

Adjusted PEC

groundwater

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

 

 

 

 

 

spring

autumn

spring

autumn

Grass seed

ethofumesate

1750

1

0.6

 

0.002185

 

0.000892

 

GeoPEARL calculations show that the predicted leachate concentrations for ethofumesate are smaller than 0.01 g/L. Hence, the active substance meets the standards laid down in the RGB for the proposed applications.

 

 

Monitoring data

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

 

Conclusions

The proposed application of the product complies with the requirements laid down in the RGB concerning persistence in soil and leaching to groundwater.

 

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.

 

Since the application is a post-emergence herbicidal treatment, it is assumed that aircraft application is not relevant.

 

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 (all on the basis of mean values):

 

TOXSWA:

 

Ethofumesate

DT50 for degradation in water at 20C: 182 days

DT50 for degradation in sediment at 20C: 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 C)

Solubility in water: 0.05 g/L (25 C)

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.

 

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 substances ethofumesate, phenmedipham and metabolite MHPC following spring application

No/ Use

Substance

Rate a.s.

[kg/ha]

Freq./

interval

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

Grass seed

Ethofumesate

1.75

n.a.

1

8.329

1.177

0.884

 

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

 

 

Monitoring data

The pesticide atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values.

Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the pesticide atlas, these monitoring data are processed into a graphic format accessible on-line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. This is for each substance represented in an aggregated way by (among others) a set of maps with grid cells of either 5 x 5 km or 1 x 1 km.

Ethofumesate

The active substance ethofumesate was observed in the surface water (most recent data from 2005-2006). In Table M.5 the number of observations in the surface water are presented.

In the pesticide atlas, surface water concentrations are compared to the authorisation threshold value 32 g/L (dated 01-04-05, C-156.3.10) consisting of first or higher tier acute or chronic ecotoxicological threshold value used for risk assessment (in this case 0.1*NOEC Daphnia) and to the Maximum Permissible Concentration (MPC) as established in the Fourth National Policy Document on Water Management (value 6.4 g/L, May 2007).

Currently, this MPC value is not harmonised, which means that not all available ecotoxicological data for this substance are included in the threshold value. In the near future and in the framework of the Water Framework Directive, new quality criteria will be developed which will include both MPC data as well as authorisation data.

The currently available MPC value is reported here for information purposes. Pending this policy development (finalisation for all substances expected in 2009-2010), however, no consequences can be drawn for the proposed application(s).

 

Table M.5 Monitoring data ethofumesate in Dutch surface water (from www.pesticidesatlas.nl)

Total no of observations

(2005-2006)

n > authorisation threshold

 

n > MPC threshold

4th Document water management

n > MPC-INS threshold *

2685

0

0

n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with 4th Document MPC value; > : exceeding expected to be higher than with 4th Document MPC value

 

No exceeding of the threshold values occurred.

 

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 Courts 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.

 

Ethofumesate

Ethofumesate has been on the Dutch market for > 3 years (authorised since 25-06-1999). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, 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 as laid down in the RGB 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 C). The Henry constant is 6.8 x 10-4 Pam3mol -1, at 25C. 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.

 

In the GAP/instructions for use the following has to be stated:

-

 

6.6 Overall conclusions fate and behaviour

It can be concluded that:

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

 

 

7.                 Ecotoxicology

 

For the current application of Tramat 500, risk assessment is done in accordance with Chapter 2 of the RGB.

 

List of Endpoints Ecotoxicology

 

Ethofumesate

Ethofumesate is an existing substance, placed on Annex I. The final List of Endpoints from the DAR 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 g/bee

Acute contact toxicity

>50 g/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%

Remarks

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

For national registration the following data are submitted:

 

Typhlodromus pyri (standard lab)

 

Aphidius rhopalopsiphi (standard lab)

 

 

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

LR50 > 1 kg a.s/ha

 

mortality: -8.3% at 0.5 kg as/ha

mortality: -8.0% at 1.0 kg as/ha

reproduction: +68.3% at 0.5 kg as/ha

reproduction: 18.7% at 1.0 kg as/ha

LR50 > 1 kg a.s./ha

 

(Test substance: AE B04991300 SC45A202, a.i. ethofumesate 44.7% w/w. Water miscible suspension concentrate, 500 g/L; Tramat 500, RIVM report 10067a01, 02/2006)

 

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)

 

NOEC 9.975 mg a.s./kg soil

(Test substance: AE B04991300 SC45A202, a.i. ethofumesate 44.7% w/w. Water miscible suspension concentrate, 500 g/L; Tramat 500, RIVM report 10067a01, 02/2006)

 

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 (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 residue trials, eleven studies were considered suitable for residue decline calculation and initial residual values on crop. All studies were performed 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/kg]

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

 

 

Additional information (summarised and evaluated by EPP Consultancy (report 100502, 05/2010)).

 

Non-target plants

Test substance

Test type

Exposure time

Species

Endpoint

 

Value

Ethofumesate; water miscible suspension concentrate (Nortron SC)*

Vegetative vigour

21 days

Allium cepa

 

L. esculentum

 

Raphanus sativus

 

Zea mays

 

Avena sativa

 

Triticum aestivum

 

Lactuca sativa

 

Glycine max

 

Cucumis sativus

 

Daucus carota

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d ER5

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d ER5

21-d ER50

21-d ER5

21-d ER50

21-d NOER

21-d ER50

5 L form./ha

>10 L form./ha

0.32 L form./ha

1.16 L form./ha

0.06 L form./ha

>10 L form./ha

≥10 L form./ha

>10 L form./ha

0.63 L form./ha

>10 L form./ha

0.32 L form./ha

1.24 L form./ha

1.25 L form./ha

>10 L form./ha

0.04 L form./ha

1.93 L form./ha

0.04 L form./ha

7.66 L form./ha

≥10 L form./ha

>10 L form./ha

 

Ethofumesate; water miscible suspension concentrate (Nortron SC)*

Seedling emergence

21 days

Daucus carota

 

Zea mays

 

Cucumis sativus

 

Lactuca sativa

 

Avena sativa

 

Allium cepa

 

Raphanus sativus

 

Glycine max

 

L. esculentum

 

Triticum aestivum

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

21-d NOER

21-d ER50

≥5 L form./ha

>5 L form./ha

≥6 L form./ha

>6 L form./ha

0.63 L form./ha

1.11 L form./ha

0.16 L form./ha

0.70 L form./ha

0.38 L form./ha

1.38 L form./ha

1.25 L form./ha

>10 L form./ha

0.32 L form./ha

>5 L form./ha

0.38 L form./ha

>10 L form./ha

0.63 L form./ha

1.05 L form./ha

0.16 L form./ha

>0.63 L form./ha

Ethofumesate

SC 500 **

Seedling emergence

14 days

F. esculentum

 

Brassica napus

 

Pisum sativum

 

Glycine max

 

Helianthus annuus

 

Brassica rapa

 

Zea mays

 

Allium cepa

 

Lolium perenne

 

Triticum aestivum

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

14-d NOER

14-d ER50

<0.156 L form./ha

0.347 L form./ha

<0.313 L form./ha

2.17 form./ha

0.313 L form./ha

2.41 L form./ha

0.625 L form./ha

3.25 L form./ha

≥1.25 L form./ha

>1.25 L form./ha

<0.313 L form./ha

1.79 L form./ha

0.313 L form./ha

0.842 L form./ha

0.625 L form./ha

1.85 L form./ha

0.078 L form./ha

0.433 L form./ha

<0.078 L form./ha

0.101 L form./ha

* SC formulation containing 438 g ethofumesate/kg

** SC formulation containing 503.5 g ethofumesate/L

 

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 birds is based on the trigger from the RGB. The threshold value for acute and short-term exposure 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 Ratios) for acute and short-term exposure should be 10 and TER for chronic exposure should be 5.

Table E.1 presents an overview of toxicity data.

 

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

 

Endpoint

Value

Ethofumesate

 

Acute toxicity to birds:

LD50

>2000 mg a.s./kg bw

Dietary toxicity to birds:

LC50

>5200 ppm, ~ 1820 mg a.s./kg bw/d1

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

 

seed production

grassland (early)

large herbivorous and insectivorous

 

Table E.3a-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)

Crop

Indicator species

FIR / bw

RUD (90%)

MAF

Application rate (kg as/ha)

Acute ETE

(mg/kg bw/d)

Grass seed production

Large herbivorous bird

0.44

142

-

1.75

109

 

Insectivorous bird (small insects)

1.04

52

-

1.75

94.6

 

Table E.3b Short-term ETE in terms of daily dose (mg/kg bw)

Crop

Indicator species

FIR / bw

RUD (mean)

MAF

Application rate (kg as/ha)

Short-term ETE

(mg/kg bw/d)

Grass seed production

Large herbivorous bird

0.44

76

-

1.75

58.5

 

insectivorous

1.04

29

-

1.75

52.8

 

Table E.3c Long-term ETE in terms of daily dose (mg/kg bw)

Crop

Crop stage

FIR / bw

RUD (mean)

MAF

fTWA

Application rate (kg as/ha)

Long-term ETE

(mg/kg bw/d)

Grass seed production

Large herbivorous bird

0.44

76

-

0.53

1.75

31.0

 

insectivorous

1.04

29

-

-

1.75

52.8

 

Based on the ETE-values in Table E.3a-c the TER-values for the acute, short-term and long-term risk are presented in table E.4.

 

Table E.4 Toxicity Exposure Ratios for exposure of birds to ethofumesate in food

Time scale

Substance

Toxicity (LD50/ LC50/ NOEL)

ETE value (mg a.s./kg bw/d)

TER value

Trigger value

Crop grass seed production, large herbivorous bird

Acute

ethofumesate

> 2000

109

> 183

10

Short-term

ethofumesate

> 1820

 

58.5

> 31.1

10

Long-term

ethofumesate

406

 

31.0

13.1

5

Crop grass seed production, insectivorous bird

Acute

ethofumesate

> 2000

94.6

> 21.1

10

Short-term

ethofumesate

> 1820

 

52.8

> 34.5

10

Long-term

ethofumesate

406

 

52.8

7.69

5

 

Taking the results in Table E.4 into account, it appears that the proposed use meets the standards laid down in the RGB.

 

drinking water

The risk from exposure through drinking surface water is calculated for a small bird with body weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIECwater is 8.33 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000 * 0.010) / (0.00833 * 0.0027) = >10000

Since TER > 10, the risk is acceptable.

 

7.1.2 Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms. Since the log Kow of ethofumesate < 3 (2.7) the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Conclusions birds

The product complies with the RGB.

 

7.2 Effects on aquatic organisms

7.2.1 Aquatic organisms

The risk for aquatic organisms for the various uses of the active substance ethofumesate is assessed by comparing toxicity values with surface water exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure ratios (TERs).

Toxicity data for aquatic organisms are presented in Table E.5 for the active substance ethofumesate. Because the application for authorisation concerns a herbicide, also the effects on macrophytes (aquatic plants) are evaluated .


 

Table E.5 Overview toxicity endpoints for the active substance and metabolite(s)

Substance

Organism

Lowest

Toxicity value

 

 

L(E)C50 [mg/L]

NOEC

[mg/L]

[mg/L]

ethofumesate

Acute

 

 

 

 

Algae

3.9

 

3900

 

Daphnids

14

 

14000

 

Fish

11

 

11000

 

Macrophytes

> 50

 

>50000

 

Chronic

 

 

 

 

Daphnids

 

0.32

320

 

Fish

 

0.8

800

 

These toxicity values are compared to the surface water concentrations calculated in section 6.2. Trigger values for acute exposure are 100 for daphnids and fish (0.01 times the lowest L(E)C50-value) and 10 for algae and macrophytes (0.1 times the lowest EC50-value). Trigger values for chronic exposure are 10 for daphnids and fish (0.1 times the lowest NOEC-values).

For acute and chronic risk, the initial concentration is used (PIEC) for TER calculation.

In table E.6 TER values for aquatic organisms are shown.

 

Table E.6a TER values: acute

use

 

Substance

TERst

(trigger 10)

TERst

(trigger 100)

TERst

(trigger 100)

TERst

(trigger 10)

 

 

Algae

Daphnid

Fish

Macrophytes

Grass seed production

ethofumesate

468

1681

1321

6002

 

Table E.6b TER values: chronic

use

 

Substance

TERlt

(trigger 10)

TERlt

(trigger 10)

 

 

Daphnid

Fish

Grass seed production

ethofumesate

38.4

96.0

 

Taking the results in Table E.6a and b into account, the acute TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 100 and the acute TERs for algae and Lemna are above the relevant Annex VI triggers of 10. The chronic TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 10. Thus, it appears that for the active substance ethofumesate the proposed use meets the standards for aquatic organisms as laid down in the RGB.

 

7.2.2 Risk assessment for bioconcentration

ethofumesate

For the active substance ethofumesate a BCF-value of 144 L/kg is available.

 

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

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

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

2)      Secondary poisoning for birds and mammals;

3)      Biomagnification in aquatic food chains

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

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

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

 

Hence, the active substance ethofumesate meets the standards for bioconcentration as laid down in the RGB.

 

7.2.3 Risk assessment for sediment organisms

The NOEC value for Chironomus is 5000 g/L. When this value is examined against the PIEC in water of 8.33 g/L, the TER value is 600 and exceeds the trigger value of 10. Therefore, the active substance ethofumesate meets the standards for sediment organisms as laid down in the RGB.

 

Conclusions aquatic organisms

The proposed application of the product complies with the RGB.

 

7.3 Effects on terrestrial vertebrates other than birds

Mammals 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 mammals is based on the trigger from the RGB. The threshold value for acute exposure is set at 0.1 times the LD50 value, and the threshold value for chronic exposure is set at 0.2 times the NOEC value. This means that TER (Toxicity-Exposure Ratio) for acute exposure should be 10 and TER for chronic exposure should be 5. Dietary toxicity is not taken into account for mammals.

Table E.7 presents an overview of toxicity data.

 

Table E.7 Overview of toxicity data for mammals for substance ethofumesate

 

Endpoint

Value

Ethofumesate

 

 

Acute toxicity to mammals:

LD50

>8000 mg a.s./kg bw

Reproductive toxicity to mammals:

NOEL

300 mg a.s./kg bw/d

 

7.3.1 Natural food and drinking water

Sprayed products

Procedures for risk assessment for mammals 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.8 shows which indicator species are relevant for which uses.

 

Table E.8 Indicator species per use

No.

Use

Crop

Indicator species

 

Grass seed production

grassland

small herbivorous

 

Table E.9a-b show the estimated daily uptake values (ETE, Estimated Theoretical Exposure) of ethofumesate for acute 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.

 

Table E.9a Acute ETE in terms of daily dose (mg/kg bw)

Crop

Indicator species

FIR / bw

RUD (90%)

MAF

Application rate (kg as/ha)

Acute ETE

(mg/kg bw/d)

Grass seed production

Small herbivorous mammal

1.39

142

-

1.75

345

 

 

Table E.9b Long-term ETE in terms of daily dose (mg/kg bw)

Crop

Indicator species

FIR / bw

RUD (mean)

MAF

fTWA

Application rate (kg as/ha)

Long-term ETE

(mg/kg bw/d)

Grass seed production

Small herbivorous mammal

1.39

76

-

0.53

1.75

97.98

 

Based on the ETE-values in Table E.9a-b the TER-values for the acute and long-term risk are presented in table E.10.

 

Table E.10 Toxicity Exposure Ratios for exposure of mammals to ethofumesate in food

Time scale

Substance

Toxicity (LD50/NOEL)

ETE value (mg a.s./kg diet/bw/d)

TER value

Trigger value

Crop Grass seed production, small herbivorous mammal

Acute

ethofumesate

>8000

345

> 23.19

10

Long-term

ethofumesate

300

97.98

3.06

5

 

Taking the results in Table E.10 into account, it appears that a long-term risk to mammals for the proposed uses cannot be excluded. A refined risk assessment is performed

 

Refined risk assessment,

In the DAR residue data from established grasslands is available. From these studies it appears that the mean RUD is 87, and the geometric mean DT50 is 3.53 days. A new long-term ETE calculation and risk assessment is given in Tables E.11 en E.12.

 

Table E.11 Long-term ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop

Indicator species

FIR / bw

RUD (mean)

MAF

fTWA

Application rate (kg as/ha)

Long-term ETE (mg/kg bw/d)

Grassland

Small herbivorous mammal

1.39

87

-

0.24

1.75

50.79

 

Based on the ETE-values in Table E.11 the TER-values for the acute and long-term risk are presented in table E.12.

 

Table E.12 Toxicity Exposure Ratios for exposure of mammals to ethofumesate in food

Time scale

Substance

Toxicity (LD50/NOEL)

ETE value (mg a.s./kg diet/bw/d)

TER value

Trigger value

Crop Ryegrass, small herbivorous mammal

Long-term

ethofumesate

300

50.79

5.91

5

 

Based on this refined risk assessment, an acceptable risk is expected for mammals.

 

Taking the results in Table E12 into account, it appears that the proposed use meets the standards laid down in the RGB.

 

drinking water

The risk from exposure through drinking from surface water is calculated for a small mammal with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIECwater is 8.33 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>8000 * 0.010) / (0.00833 * 0.00157) = >10000

Since TER > 10, the risk is acceptable.

 

7.3.2 Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms.

Since the log Kow of ethofumesate < 3 (2.7), the potential for bioaccumulation is considered low and no further assessment is deemed necessary.