Toelatingsnummer 12521 N

TRAMAT 500  

 

12521 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 VEREENVOUDIGDE UITBREIDING

 

Gelet op de aanvraag d.d. 6 december 2010 (20101040 VUG) van

 

Stichting Trustee Bijzondere Toelatingen

Hogeweg 16

2585 JD  'S-GRAVENHAGE

 

 

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

 

TRAMAT 500

 

gelet op artikel 31, 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 zaadteelt van Westerwolds raaigras, roodzwenkgras, rietzwenkgras, veldbeemdgras, beemdlangbloem, timothee, kropaar, ruwe smele en fakkelgras en de teelt van graszoden. Voor de gronden van dit besluit 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.

 

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

 

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

 

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

 

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

 

1.5 Aflever- en opgebruiktermijn

Het nieuwe WG/GA dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt.

 

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

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. De aanvraag is gedaan door Stichting Trustee Bijzondere Toelatingen.

Het middel is bij besluit van 27 februari 2004 reeds toegelaten als onkruidbestrijdingsmiddel in de teelt van de teelt van suiker- en voederbieten en de zaadteelt van Engels en Italiaans raaigras.

 

Met onderliggende aanvraag wordt toelating als onkruidbestrijdingsmiddel voor de zaadteelt van Westerwolds raaigras, roodzwenkgras, rietzwenkgras, veldbeemdgras, beemdlangbloem, timothee, kropaar, ruwe smele en fakkelgras en de teelt van graszoden gevraagd.

 

Ten aanzien van de volgende aspecten is verzocht de vereenvoudigde uitbreidingsprocedure  te volgen: Fysische en chemische eigenschappen, analysemethoden en werkzaamheid.

 

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). De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011 (stof 29)).

 

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 de stof wordt opgenomen door het blad. De opname door het blad (incl. opnamesnelheid) neemt af naarmate de onkruiden groter zijn. Ethofumesaat werkt op éénjarige grassen en éénjarige tweezaadlobbige onkruiden.

 

2.4 Voorgeschiedenis

De aanvraag is op 8 december 2010 ontvangen; op 20 december 2010 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 21 juli 2011 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

Niet beoordeeld in het kader van deze aanvraag.

 

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

Niet beoordeeld in het kader van deze aanvraag.

 

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, 6 april 2012

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,






                                                                       ir. P.A.E. van Erkelens

                                                                      plv. voorzitter


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I professioneel bij het besluit d.d. 6 april 2012 tot vereenvoudigde uitbreiding van de toelating van het middel TRAMAT 500, toelatingnummer 12521 N

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in:

a.      de teelt van suiker- en voederbieten;

b.      de zaadteelt van Engels en Italiaans raaigras

c.      de zaadteelt van Westerwolds raaigras, roodzwenkgras, rietzwenkgras, veldbeemdgras, beemdlangbloem, timothee, kropaar, ruwe smele en fakkelgras

d.      de teelt van graszoden.

 

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

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

 B.

GEBRUIKSAANWIJZING

 

Het gebruik in de zaadteelt van Westerwolds raaigras, roodzwenkgras, rietzwenkgras, veldbeemdgras, beemdlangbloem, kropaar, timothee, ruwe smele en fakkelgras en het gebruik in de graszodenteelt is toegestaan op basis van een “derdenuitbreiding”. Deze “derdenuitbreiding” is aangevraagd door de Stichting Trustee Bijzondere Toelatingen. Voor deze uitbreiding is geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt.

 

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.

 

Dit middel 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 Tramat 500 per hectare + 2 liter van een middel op basis van fenmedifam (ong. 160 g fenmedifam/L) per hectare in 200-250 liter water per hectare.
Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,3 liter Tramat 500 per hectare + 2 liter van een middel op basis van fenmedifam (ong. 160 g fenmedifam/L) 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 Tramat 500 per hectare + 5 liter van een middel op basis van fenmedifam (ong. 160 g fenmedifam/L) 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 18°C en niet bij scherp, zonnig weer; in deze gevallen bij voorkeur ’s avonds spuiten.

 

Mengvoorschrift

§         giet 20-50 liter water in de tank;

§         voeg een middel op basis van 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.

 

Tramat 500 toepassen in 200-300 liter water per hectare.

 

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.

 

Zaadteelt van Westerwolds Westerwolds raaigras, roodzwenkgras, rietzwenkgras, veldbeemdgras, beemdlangbloem, timothee, kropaar, ruwe smele en fakkelgras, ter bestrijding van duist, windhalm en straatgras.

 

Tramat 500 kan voor opkomst van het gewas worden toegepast of na opkomst, 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.

 

Tramat 500 toepassen in 200-300 liter water per hectare.

 


Doseringen:

·         voor opkomst        1 liter per hectare tegen straatgras

                                    2  liter per hectare tegen duist en windhalm

·         na opkomst          3 liter per hectare tegen duist en windhalm met minder dan 3 spruiten                             3,5 liter per hectare tegen duist en windhalm met 3-5 spruiten

 

Grote duist en windhalm worden niet meer bestreden.

 

Bij bekend gevoelige grassoorten zoals roodzwenkgras en fakkelgras dienen lagere doseringen te worden gebruikt:

·         voor opkomst        0,5 liter per hectare tegen straatgras

·         na opkomst          2 liter per hectare tegen straatgras

 

Bij twijfel over de gevoeligheid voor Tramat 500 altijd contact opnemen met de teeltbegeleider.

 

Graszodenteelt, ter bestrijding van duist, windhalm, straatgras, muur en herderstasje

 

Tramat 500 bestrijdt duist, windhalm, straatgras, muur en herderstasje in de graszode.

Tramat kan voor opkomst van het gewas worden toegepast of na opkomst, vanaf het moment dat het gewas 2 spruiten heeft gevormd.

 

Tramat 500 toepassen in 200-300 liter water per hectare.

 

Dosering:

§         voor opkomst       0,5-1 liter per hectare

§         na opkomst          2 liter per hectare

 

De dosering moet worden afgestemd op de gevoeligheid van het gebruikte graszaadmengsel. Bij twijfel over de gevoeligheid voor Tramat 500 contact opnemen met de teeltbegeleider.

 

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, maďs, 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.


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 6 april 2012 tot vereenvoudigde uitbreiding van de toelating van het middel TRAMAT 500, toelatingnummer 12521 N

 

Contents

                                                                                                                                              Page

1.     Identity of the plant protection product 2

2.     Physical and chemical properties. 2

3.     Methods of analysis. 2

4.     Mammalian toxicology. 3

5.     Residues. 8

6.     Environmental fate and behaviour. 9

7.     Ecotoxicology. 22

8.     Efficacy. 37

9.     Conclusion. 37

10.   Classification and labelling. 37

 


1.                  Identity of the plant protection product

 

1.1       Applicant

Stichting Trustee Bijzondere Toelatingen

Hogeweg 16 

2585 JD 'S-GRAVENHAGE

 

 

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

The product is a herbicide.

 

1.5              Overview of uses applied for

The uses applied for are given in Table 1 (Appendix 1).

 

1.6              Background to the application

The application concerns a simplified third party extension request (see Appendix 1). Tramat 500 is already authorised as a herbicide in annual monocotyledonous and dicotyledonous weeds

For the evaluation of Tramat 500, registration number 12521 N is referred to the assessment of 5 November 2010. The assessments for physical and chemical properties, methods of analysis and efficacy are carried out using the simplified procedure.

 

1.7              Packaging details

Packaging details do not change.

 

2.                  Physical and chemical properties

The physical and chemical properties of the plant protection product remain unchanged.

 

3.                  Methods of analysis

The simplified extension of Tramat 500 in the production of grass seeds and grass sods does not involve application on crops for human consumption and animal feed. Therefore, no additional data concerning residue analytical methods for food/feed of plant and animal origin is required.


 

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/6503/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 Appendix 1.

 

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/risk

Exposure to ethofumesate during mixing and loading and application of Tramat 500 is estimated with models. The exposure is estimated for the unprotected operator. In 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 end-points relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

Based on this evaluation, no additional data requirements are identified.

 

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 and sod production). Residues in succeeding crops were investigated in root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach) and cereals (wheat, grain, corn) and are covered by the List of Endpoints of January 2002. No detectable residue levels are expected in rotational crops. Therefore, an assessment of the residual behaviour of ethofumesate is not necessary. The risk for consumers is considered to be negligible.

 

Based on the current assessment, the following has to be stated in the WG (legal instructions for use):

 

Veiligheidstermijn

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

 

5.4              Data requirements

No data requirements were identified.

 

6.         Environmental fate and behaviour

The applicant holds a letter of acces from the notifier of ethofumesate Bayer CropScience and has access to Annex II dossier of ethofumesate. For Betanal Expert 20110844 WGAGG, a plant protection product of Bayer CropScience, Bayer CropScience provided a statement with a refinement of the DT50 values for active substance ethofumesate. These are used for the current application. The comments of the Bayer CropScience and Ctgb are included in the list of endpoints in italics and recalculations were made and included.

 

List of Endpoints Fate/behaviour  (Review report, SANCO/6503/VI/99-final, 15 may 2002)

 

Route of degradation

 

Aerobic:

 

Mineralization after 100 days:

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

Non-extractable residues after 100 days:

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

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

All less than 6%

 

 

Supplemental studies

 

Anaerobic:

Not relevant because of very slow transformation

 

 

Soil photolysis:

DT50  two studies :

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

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

 

 

Remarks:

None

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 °C, aerobic):

40 - 75% WHC:

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

DT90lab (20 °C, aerobic):

40 - 75% WHC:

range 210 – 701 d; median 331 d; n=10

DT50lab (10 °C, aerobic):

No study.

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

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

DT50lab (20 °C, anaerobic):

Very slow transformation: 90-100% unaltered

after 60 d; n=2

 


 

Field studies (country or region)

 

DT50f from soil dissipation studies:

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

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

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

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

n=13

After standardization of the studies: median: 29 days

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.

 

By letter of 10 October 2011 Bayer CropScience provided a new kinetic evaluation of the Soil Dissipation of Ethofumesate under Field Conditions.

 

The field dissipation trials with ethofumesate have been re-evaluated and normalized to standard conditions using the new Q10=2.58 by Schmitt (2008). The respective results are given in the next Table 1. Twelve normalized DT50 values were derived ranging from 15 d to 101.5 d with a geometric mean of 36.2 d and a median of 29 d.

 

Comments Ctgb

For this re-assessment for ethofumesate, the applicant submitted a Focus degradation kinetics evaluation study, in which the available field DT50 values were evaluated and standardised for groundwater modelling. These normalised DT50 values ranged from 15 to 102 days. The median value is 29 days. According to the current guidance this DegT50 value can be used for refined assessment.

 


Adsorption/desorption

 

Kf / Koc:

 

Kd

 

pH dependence:

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

 

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

 

Not pH dependent.

 

Mobility

 

Laboratory studies:

 

Column leaching:

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

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

Aged residue leaching:

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

 

 

Field studies:

 

Lysimeter/Field leaching studies:

Two studies according to BBA guideline:

 

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

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

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

 

 

Remarks:

None.

 

Statement of the Bayer CropScience

In the EU List of end-points ((SANCO/6503/VI/99-fmal date 15 May 2002) Ethofumesate) there is an error. The mean Koc has been incorrectly stated. 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 monograph (the values for the sediment (Vonk et al. 1988) have been excluded from the calculation of the mean). 1/n values were not reported in the List of End-points but were included in the study summaries in the monograph. From this data it can be calculated that the mean Koc is 157 L/kg and the mean 1/n is 0.89, these values should be used as the basis for input data for PEC calculations.

 

Comments Ctgb

The Ctgb agrees that the Koc endpoint given in the LoEP is not correct. This should be 157 L/kg (Kom 90.8 L/kg). Using the mean Koc as proposed by the applicant for modelling is incorrect. The median Koc should be used instead because 11 data points are available (this is in accordance with the EU and NL guidance in HTB1.0). The median Koc is 132 L/kg (Kom of 77 L/kg) and is correctly given in the LoEP. The proposed value of 1/n by the applicant is agreed by the Ctgb and can be used for modelling purposes.

 

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

Major metabolites:

None identified.

 

 

Biological degradation

 

Readily biodegradable:

Not readily biodegradable; n=3

Water/sediment study:

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

DT50 water:

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

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

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

DT90 water:

Study 1:   -

Study 2: 121 and 212 days, n=2

Study 3: -

DT50 whole system:

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

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

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

DT90 whole system:

Study 1: -

Study 2: 507 and 550 days, n=2

Study 3: -

Distribution in water / sediment systems
(active substance)

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

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

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

Distribution in water / sediment systems
(metabolites)

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

Accumulation in water and/or sediment:

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

Rate of mineralisation

 

Non-extractable residues

6-9%

 

27%

Degradation in the saturated zone

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

 

 

Remarks:

None.

 

Fate and behaviour in air

Volatility

 

Vapour pressure:

6.5 x 10-4 Pa (25 °C)

Henry's law constant:

6.8 x 10-4 Pa×m3×mol -1 (25 °C)

 

 

Photolytic degradation

 

Direct photolysis in air:

Data not required.

Photochemical oxidative degradation in air

DT50:

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

4.1 h, calc. According to Atkinson

Volatilisation:

From plant surfaces:

22% lost from plant surface during 24 hours

From soil:

15% lost from soil surface during the first 24 hours

 

 

Remarks:

No remarks.

 

Appendix A: Metabolite names, codes and other relevant information of the pesticide Tramat 500 with active substance ethofumesate.

The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of ethofumesate. The parent compound structure of ethofumesate

is shown first in this list and followed by degradation or related compounds.

 

Compound name

Code number(s)

IUPAC name

Structural formula

Structure

Molecular Weight

[g/mol]

Observed in study (% of occurrence/ formation)

Ethofumesate

-

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

C13H18O5S

 

286.3

parent

 

 

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].

 

Preceding the harmonisation of the persistence assessment in The Netherlands with regulation 1107/2009/EG, the EU approach for persistence assessment is followed.

 

For the current application this means the following:

 

Active substance 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 active substance 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: geometric mean non-normalised DT50 is 55.2 days, range 29 – 133 days, median DT50is 47 days. From the results it is shown that the average field DT50 is < 90 days.

 

There are no major metabolites.

 

Based on the above, the standards of persistence as laid down in the RGB are met.

 

PECsoil

The concentration of active substance 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.

 

As the logPow of the substance is < 3 (2.7), a PEC21days is not needed for the assessment of secondary poisoning of birds and mammals through the consumption of earthworms.

 

The following input data are used for the calculation:

 

PEC soil:

 

Active substance ethofumesate:

Maximum field DT50 for degradation in soil: 133 days

Molecular mass: 286.3 g/mol

 

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

 

Table M.1 PECsoil calculations for active substance ethofumesate (5 cm)

Use

Substance

Rate

 

[kg a.s./ha]

Freq. /interval

[days]

Fraction on soil *

PIECsoil

(5 cm)

[mg a.s./kg]

Grass seed production

ethofumesate

1.0

1 / n.a.

1.0

1.333

Grass seed production

ethofumesate

1.75

1 / n.a.

0.6

1.400

Sod production

ethofumesate

0.5

1 / n.a.

1.0

0.667

Sod production

ethofumesate

1.0

1 / n.a.

0.6

0.800

* fraction on soil is determined as 1 – interception value; interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. An interception of 0.4 is appropriate for grass at BBCH 10-19. For pre-emergence an interception of 0 is applied

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.

 

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 4.4.4 and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate of 2 kg/ha, the crop (grass) and an interception value appropriate to the crop stage of 0.6. Date of yearly spring application is May 25th (default) and for autumn application is November 1st.

 

The following input data are used for the calculation:

PEARL:

 

Active substance ethofumesate:

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

Median standardised field DT50 for degradation in soil: 29 days*

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

Arithmetic mean 1/n: 0.89

 

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

Solubility in water: 50 mg/L (25°C)

Molecular mass: 286.3 g/mol

 

Plant uptake factor: 0.5 (systemic active substance)

Q10: 2.2

 

Other parameters: standard settings of PEARL 4.4.4

* For this re-assessment for ethofumesate, Bayer CropScience submitted a Focus degradation kinetics evaluation study, in which the available field DT50 values were evaluated and standardised for groundwater modelling. These normalised DT50 values ranged from 15 to 102 days. The median value is 29 days. This DT50 value can be used for refined assessment.

 

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

 

Table M.2a Leaching of active substance ethofumesate as predicted by PEARL 4.4.4 (bold predicted leaching concentration > 0.1 µg/L underlined predicted leaching concentration > 0.01 µg/L and < 0.1 µg/L)

Use

Substance

Rate substance [kg/ha]

Frequency/ Interval [days]

Fraction

Intercepted *

PEC

groundwater [mg/L]

 

 

 

 

 

spring

autumn

Grass seed production

ethofumesate

1.0

1 / n.a.

0.0

4.177

5.045

Grass seed production **

ethofumesate

1.0

1 / n.a.

0.0

0.006

0.012

Grass seed production

ethofumesate

1.75

1 / n.a.

0.4

4.471

5.385

Grass seed production **

ethofumesate

1.75

1 / n.a.

0.4

0.007

0.014

Sod production

ethofumesate

0.5

1 / n.a.

0.0

1.603

1.959

Sod production **

ethofumesate

0.5

1 / n.a.

0.0

0.001

0.003

Sod production

ethofumesate

1.0

1 / n.a.

0.4

2.060

2.535

Sod production **

ethofumesate

1.0

1 / n.a.

0.4

0.002

0.004

* interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. An interception of 0.4 is appropriate for grass at BBCH 10-19. For pre-emergence an interception of 0.0 is applied.

** For this re-assessment for ethofumesate, Bayer CropScience submitted a Focus degradation kinetics evaluation study, in which the available field DT50 values were evaluated and standardised for groundwater modelling. These normalised DT50 values ranged from 15 to 102 days. The median value is 29 days. This DT50 value can be used for refined assessment.

 

Results of Pearl 4.4.4 using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2a it reads that the expected leaching based on the PEARL-model calculations for the active substance ethofumesate the predicted concentration based on laboratory data is larger than 0.1 µg/L. For the field, the predicted concentration for some applications are below 0.01 µg/L and for two autumn applications the predicted concentration is larger than 0.01 µg/L but smaller than 0.1 µg/L. The proposed applications meet the standards for leaching. However, as the predicted concentration for active substance ethofumesate is larger than 0.01 µg/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

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

 

This standardisation has been performed. For this standardisation the percolate concentration has been put on 0.0049 µg/L, just below the detection limit, to be able to calculate the cumulative leaching from the lysimeter. Because there are no DT50 and Kom values for the lysimetersoil available, worst-case values have been used (lowest DT50 value and the highest Kom-value). The simulation error (SE) is calculated by Slysi/Mlysi, the simulated leaching divided by the measured leaching. For the lysimeters simulation errors 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 9.1 and the corrected maximum calculated concentration in the groundwater is 0.443 µg/L.

Since standardisation of the lysimeter was based on laboratory data, the results cannot be used for correcting the model output based on field data. If the applicant wants to use these lysimeter studies, a new standarsdisation is required.

 

For active substance ethofumesate, expected leaching is larger than 0.1 and 0.01 µg/L. Therefore, further study into the leaching behaviour was done. In the second tier leaching assessment, leaching in potential area of use is evaluated using the spatial distribution model GeoPEARL 3.3.3.

 

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 4.4.4 is employed with the refined field degradation data. Additional input is the crop and the number of plots (minimum 250). For results see Table M.2b.

 

The same input data as used in the first tier with Pearl 4.4.4 is employed. Additional input is the crop and the number of plots (minimum 250). For results see Table M.2b.

 

Table M.2b Leaching of active substance ethofumesate as predicted by GeoPEARL 3.3.3

Use

Substance

Rate a.s. [kg/ha]

Frequency/ Interval [days]

Fraction

Intercepted *

PEC

groundwater [mg/L]

 

 

 

 

 

Autumn

Grass seed production

ethofumesate

1.0

1 / n.a.

0.0

0.006

Grass seed production

ethofumesate

1.75

1 / n.a.

0.4

0.007

* interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. An interception of 0.4 is appropriate for grass at BBCH 10-19. For pre-emergence an interception of 0.0 is applied.

 

GeoPEARL calculations show that the predicted leachate concentrations for ethofumesate are smaller than 0.1 and also smaller than 0.01 µg/L indicating no restriction sentence is required. Hence, the active substance meets the standards laid down in the RGB for the proposed applications.

 

Monitoring data

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90th percentile.

 

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

 

Conclusions

The active substance ethofumesate complies with the standards for persistence in soil laid down in the RGB.

 

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

 

6.2       Fate and behaviour in water

6.2.1    Rate and route of degradation in surface water

Article 2.10c of the Plant Protection Products and Biocides Regulations (RGB) prescribes the use of Dutch specific drift percentages.

 

The exposure concentrations of the active substance ethofumesate in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percen­tage depends on the use.

 

Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation:

 

TOXSWA:

Active substance ethofumesate:

Geometric mean DT50 for degradation in water at 20°C: 114.6 days (only SFO fits taken into account)

DT50 for degradation in sediment at 20°C: 1000 days (default).

 

Median Kom for suspended organic matter: 77 L/kg

Median Kom for sediment: 77 L/kg

Arithmetic mean 1/n: 0.89

 

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

Solubility in water: 0.05 g/L (25°C)

Molecular mass: 286.3 g/mol

Q10: 2.2

 

Other parameters: standard settings TOXSWA

 

When no separate degradation half-lives (DegT50 values) are available for the water and sediment compartment (accepted level P-II values), the system degradation half-life (DegT50-system, level P-I) is used as input for the degrading compartment and a default value of 1000 days is to be used for the compartment in which no degradation is assumed. This is in line with the recommendations in the FOCUS Guidance Document on Degradation Kinetics. Only spring scenarios are calculated as these provide worst case exposure concentrations. See Table M.3a for results.

 

Table M.3a Overview of surface water concentrations for active substance ethofumesate in the edge-of-field ditch following spring application

Use

Substance

Rate a.s.

[kg/ha]

Freq./ Interval [days]

Drift

 

[%]

PIEC

 

[mg/L] *

PEC21

 

[mg/L] *

PEC28

 

[mg/L] *

Grass seed production

ethofumesate

1.0

1 / n.a.

1

4.760

4.232

4.076

Grass seed production

ethofumesate

1.75

1 / n.a.

1

8.330

7.418

7.145

Sod production

ethofumesate

0.5

1 / n.a.

1

2.380

2.112

2.033

Sod production

ethofumesate

1.0

1 / n.a.

1

4.760

4.232

4.076

* calculated according to TOXSWA

 

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

 

Monitoring data

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90th percentile.

 

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. Recently, the new version 2.0 was released. This new version of the Pesticide Atlas does not contain the land use correlation analysis needed to draw relevant conclusions for the authorisation procedure. Instead a link to the land use analysis performed in version 1.0 is made, in which the analysis is made on the basis of data aggregation based on grid cells of either 5 x 5 km or 1 x 1 km.

 

Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation threshold and the MPC (ad-hoc or according to INS) threshold. For examination against the drinking water criterion, another database (VEWIN) is used, since the drinking water criterion is only examined at drinking water abstraction points. For the assessment of the proposed applications regarding the drinking water criterion, see next section.


Active substance ethofumesate

The active substance ethofumesate was observed in the surface water (most recent data from 2010). In Table M.4 the number of observations in the surface water are presented.

In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 32.0 µg/L (4/9/2009, C-200.3.8, consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.1*NOEC Daphnia) and to the indicative Maximum Permissible Concentration (MPC) of 6.4 µg/L as presented in the Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer, http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php).

 

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, however, no consequences can be drawn for the proposed application.

 

Table M.4 Monitoring data in Dutch surface water (from www.pesticidesatlas.nl, version 2.0)

Total no of locations

(2010)

n > authorisation threshold

n > indicative/ad hoc MPC threshold

n > MPC-INS threshold *

417**

0

0

n.a.

* n.a.: no MPC-INS available

** the number of observations at each location varies between 1 and 30, total number of measurements is 2114 in 2010.

 

As there are no exceedings of thresholds, the monitoring data have no consequences for the proposed use of the product.

 

Drinking water criterion

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90th percentile.

 

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’. The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635[4].

 

Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).

-          For new substances, a preregistration calculation is performed.

-          For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board).

o        If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows this VEWIN assessment.

o        If for an existing substance based on monitoring data a potential problem is identified by VEWIN, Ctgb assesses whether the 90th percentile of the monitoring data meet the drinking water criterion at each individual drinking water abstraction point.

 

Active substance ethofumesate

Active substance 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. The existing active substance ethofumesate is included in the list of substances of concern due to its presence in surface water at drinking water abstraction points as established by VEWIN/Ctgb. Therefore, an adequate risk assessment is needed based on the highest tier data. There are monitoring data concerning the presence of ethofumesate at drinking water abstraction points. See Table M.5.

 

Table M.5 Monitoring data for ethofumesate at drinking water abstraction points from surface water in the period 2006 – 2010

Abstraction point

Number of measurements above detection limit/ Number of measurements

[n/N]

Number of measurements above drinking water limit/ Number of measurements

[n/N]

Overall

90-percentile

 

 

 

[μg/L]

Andijk

0/26

0/26

0.010

Nieuwegein

0/39

0/39

0.010

Amsterdam-Rijn kanaal (Nieuwersluis)

0/26

0/26

0.010

Brakel

2/65

0/65

0.010

Heel

0/5

0/5

0.021

Petrusplaat/Keizersveer

16/65

1/65

0.050

Scheelhoek/Stellendam

6/55

0/45

0.016

Drentsche Aa (De Punt)*

1/~170

1/~170

n.c.

* for Drentsche Aa, only one sample (in 2009, the 2010 data are not yet available for the Drentsche Aa) was reported above the detection limit and also above the drinking water limit. About 170 sample points are indicated in the data set, however no detection limit is provided. It is considered that the 90-percentile is below 0.1 µg/L.

 

The relevant monitoring data (data set VEWIN, 2006 -2010) indicate that the 90-percentile concentrations of each individual abstraction point do not exceed the threshold of 0.1 µg/L. Therefore, the application of Tramat 500 is not expected to exceed 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

Active substance ethofumesate

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

 

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

 

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

See List of End-points.

 

6.5              Data requirements

-

 

The following restriction sentences were proposed by the applicant:

Toepassing door middel van een luchtvaartuig is niet toegestaan.

Aircraft application of plant protection products is prohibited in the Netherlands since November 2011, i.e. the restriction sentence can be removed from the WG.

 

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use:

-


 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

  1. the active substance ethofumesate meets the standards for persistence in soil as laid down in the 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 as laid down in the RGB.

 

 

7          Ecotoxicology

 

Risk assessment is done in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011).

The Stichting Trustee Bijzondere Toelatingen submitted an application for the simplified extension of use of Tramat 500 in several grasses for seed production and in sod production. This simplified extension in grass seed and sod production is based on the extension of Tramat 500 in ryegrass seed production which was authorised in October 2010 (C-222.3.1). Bayer CropScience supports this application with a Letter of Access.

 

List of Endpoints Ecotoxicology

 

Ethofumesate

Ethofumesate is an existing substance, placed on Annex I. The final List of Endpoints from the Final Review Report (02/2002) is used for the risk assessment. Comments and additions are given in italic.

 

Terrestrial Vertebrates

Acute toxicity to mammals:

LD50 > 5000 mg/kg bw (rat)

Acute toxicity to birds:

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

Dietary toxicity to birds:

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

NOEC = 2600 mg/kg feed

Reproductive toxicity to birds:

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

Reproductive toxicity to mammals:

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

 

Aquatic Organisms

Acute toxicity fish:

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

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

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

Long term toxicity fish:

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

Bioaccumulation fish:

144 (based on total radioactivity)

Acute toxicity invertebrate:

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

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

Chronic toxicity invertebrate:

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

Acute toxicity algae:

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

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

Chronic toxicity sediment dwelling organism:

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

Acute toxicity aquatic plants:

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

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

 

 

Remarks

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

 

Honeybees

Acute oral toxicity

>50 µg/bee

Acute contact toxicity

>50 µg/bee

 

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.

*Not included in Final version of LoE, but added by Ctgb from a previous version.

 

Other arthropod species

NB The format of this Table is different from that in the final LoE but considered more useful and therefore included by Ctgb. Endpoints are all the same.

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).

 

Earthworms

Acute toxicity

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)

 

Soil micro-organisms

Nitrogen mineralization

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

Carbon mineralization

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

 

Effects on non-target flora and fauna

These data are presented in the DAR and early versions of the LoE and were added to the final LoE by Ctgb because they are useful for the risk assessment.

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

 

Residue data

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

 

 

Non-target plants

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

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 Ratio’s) for acute and short-term exposure should be ł 10 and TER for chronic exposure should be ł 5.

Table E.1 presents an overview of toxicity data.

 

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

 

Endpoint

Value

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

Use

Crop

Indicator species

grass seed and sod production

grassland

large herbivorous and insectivorous

 

Table E.3a-c show the TER values for birds. The estimated daily uptake values (ETE, Estimated Theoretical Exposure) for acute, short-term and long-term exposure are calculated 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 > 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]. The ETE is compared to the relevant toxicity figure. TER should be above the trigger for an acceptable risk. In first instance, only the risk of the worst-case use (post-emergence of the crop, highest application rate of 1.75 kg a.s./ha) is calculated.

 

Table E.3a Acute risk for birds

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

Acute ETE

LD50 (mg/kg bw/d)

TER

(mg/kg bw/d)

(trigger 10)

large herbivorous bird

ethofumesate

0.44

142

1.75

1

109

>2000

>18.3

insectivorous bird

 

 

 

 

 

ethofumesate

1.04

52

1.75

n.a.

94.6

>2000

>21.1

 

Table E.3b Short-term risk for birds

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

Short-term ETE

LC50 (mg/kg bw/d)

TER

(mg/kg bw/d)

(trigger 10)

large herbivorous bird

ethofumesate

0.44

76

1.75

1

58.5

>1820

>31.1

insectivorous bird

 

 

 

 

 

ethofumesate

1.04

29

1.75

n.a.

52.8

>1820

>34.5

 

Table E.3c Long-term risk for birds

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

ftwa

Long-term ETE

NOEL (mg/kg bw/d)

TER

 

(mg/kg bw/d)

(trigger 5)

large herbivorous bird

ethofumesate

0.44

76

1.75

1

0.53

31.0

406

13.1

insectivorous bird

 

 

 

 

 

 

ethofumesate

1.04

29

1.75

n.a.

n.a.

52.8

406

7.69

 

Taking the results in Table E.3 into account, it appears that all proposed uses meet 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) = >8.9*105. 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 ratio’s (TERs).

Toxicity data for aquatic organisms are presented in Table E.4 for the active substance ethofumesate. Because the application for authorisation concerns a herbicide, also the effects on macrophytes (aquatic plants) are evaluated .

 

Table E.4 Overview toxicity endpoints for aquatic organisms

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

 

 

 

 

 

Tramat 500

Acute

 

 

 

 

Fish

26

 

26000

 

Daphnids

30

 

30000

 

The toxicity values indicated in bold (these are the lowest values per group) 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.5 TER values for aquatic organisms are shown.

 

Table E.5a TER values: acute

use

 

Substance

TERst

(trigger 10)

TERst

(trigger 100)

TERst

(trigger 100)

TERst

(trigger 10)

 

 

Algae

Daphnid

Fish

Macrophytes

Grass seed and sod production

ethofumesate

468

1681

1321

6002

 

Table E.5b TER values: chronic

use

 

Substance

TERlt

(trigger 10)

TERlt

(trigger 10)

 

 

 

Daphnid

Fish

 

Grass seed and sod production

ethofumesate

76.8

96.0

 

 

 

 

 

 

 

Taking the results in Table E.5a 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 µg/L. When this value is examined against the PIEC in water of 8.33 µg/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 ł 10 and TER for chronic exposure should be ł 5. Dietary toxicity is not taken into account for mammals.

Table E.6 presents an overview of toxicity data.

 

Table E.6 Overview of toxicity data for mammals for substance ethofumesate

 

Endpoint

Value

Ethofumesate

 

 

Acute toxicity to mammals:

LD50

>5000 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.7 shows which indicator species are relevant for which uses.

 

Table E.7 Indicator species per use

Use

Crop

Indicator species

grass seed and sod production

grassland

small herbivorous

 

Table E.8a-b show the estimated daily uptake values (ETE, Estimated Theoretical Exposure) 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. The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* fTWA, only for long term]. The ETE is compared to the relevant toxicity figure. TER should be above the trigger for an acceptable risk. In first instance, only the risk of the worst-case use (post-emergence of the crop, highest application rate of 1.75 kg a.s./ha) is calculated.

 

Table E.8a Acute risk for mammals

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

Acute ETE

LD50 (mg/kg bw/d)

TER

(mg/kg bw/d)

(trigger 10)

small herbivorous mammal

 

 

 

 

 

combination

1.39

142

1.75

-

345

>5000

14

 

Table E.8b Long-term risk for mammals

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

ftwa

Long-term ETE

NOEL (mg/kg bw/d)

TER

 

(mg/kg bw/d)

(trigger 5)