Toelatingsnummer 13135 N

Force  

 

13135 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 TOELATING

 

Gelet op de aanvraag d.d. 27 oktober 2006 (20060680 TG) van

 

Syngenta Crop Protection B.V.

Jacob Obrechtlaan 3 a

4611 AP  BERGEN OP ZOOM

 

 

 

tot verkrijging van een toelating op basis van de werkzame stof tefluthrin,

 

Force

 

gelet op artikel 121, eerste lid, jo. artikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

Dit besluit is per 10 december 2008 van kracht.

 

1.1  Toelating

1.      Het middel Force is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 13135 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.      De toelating geldt tot 1 januari 2019.

 

1.2  Samenstelling, vorm en verpakking

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

 

1.3  Gebruik

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

 


1.4 Classificatie en etikettering

 

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

 

1.    De aanduidingen, welke ingevolge artikel 36 van de Wet milieugevaarlijke stoffen en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: Suspensie concentraat voor zaadbehandeling

 

werkzame stof:

gehalte:

tefluthrin

200 g/l

 

 

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof(fen):  

-

 

gevaarsymbool:

aanduiding:

Xi

Irriterend

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

Kan overgevoeligheid veroorzaken bij contact met de huid.

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

Dampen kunnen slaperigheid en duizeligheid veroorzaken.

 

 

Veiligheidsaanbevelingen:

 

Niet roken tijdens gebruik.

Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor het gezicht.

Draag geschikte handschoenen bij hanteren van behandeld zaaizaad.

Deze stof en de verpakking als gevaarlijk afval afvoeren. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt:

1)      Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven.

2)      Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd.

3)      Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)

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

 


Specifieke vermeldingen:

 

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

 

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

 

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

 

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

 

 - 

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot verkrijging van een toelating van het middel Force (13135 N), een middel op basis van de werkzame stof tefluthrin. Het middel wordt aangevraagd als insectenbestrijdingsmiddel voor de suiker- en voederbietenteelt door middel van een zaadbehandeling.

 

2.2 Informatie met betrekking tot de stof

De werkzame stof tefluthrin betreft een voor Nederland nieuwe stof. Er zijn in Nederland nog geen andere middelen op basis van deze werkzame stof toegelaten.

Tefluthrin is een stof op lijst 3b van de EU. De stof is nog niet geplaatst op Bijlage I van Richtlijn 91/414/EEG. Er is wel een DAR beschikbaar. RMS is Duitsland.

 

2.3 Karakterisering van het middel

Tefluthrin, de werkzame stof van Force, is een niet-systemisch pyrethroid bodeminsecticide. De werking van pyrethroiden berust op het verstoren van de Na-kanalen in zenuwcelmembramen, waardoor de zenuwtransportfunctie verstoord wordt.

De pyrethroiden binden aan spanningsgevoelige natrium kanalen en veranderen de transport kinetiek van de zenuwcelmembramen. De prikkeldoorgifte wordt ontregeld,wat leidt tot ongecontroleerd stimulering van weefsel (spier, zenuw etc,) wat uiteindelijk leidt tot de dood van het insect.

Force is een breedwerkend insecticide dat belangrijke bodemplagen goed bestrijdt.

Na toepassing als zaadbehandeling, dringt de damp door in de bodem en penetreert de bodeminsecten, wat leidt tot de beëindiging van de voedselopname, en de dood van het insect. Door de sterke afwerende werking, biedt de werkzame stof extra bescherming aan de kiemplanten bij het begin van de groei.

 

2.4 Voorgeschiedenis

De aanvraag is op 31 oktober 2006 ontvangen; op 27 oktober 2006 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 16 april 2007 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is de Handleiding toelating bestrijdingsmiddelen (HTB) versie 0.2.

 

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 Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Force op basis van de werkzame stof tefluthrin voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, 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, 17 december 2008

 

 

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. 17 december 2008 tot toelating van het middel Force, toelatingnummer 13135 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als middel voor behandeling van zaden van suikerbieten en voederbieten ter voorkoming van schade door insecten.

 

Uitzaai van behandeld zaad is alleen toegelaten met behulp van precisiezaai van gepilleerd zaad, waarbij het behandelde zaad direct met grond bedekt wordt.

 

Om de vogels en zoogdieren te beschermen moet het product volledig in de bodem worden ondergewerkt; zorg ervoor dat het product ook aan het voorend is ondergewerkt, en moet u gemorst product verwijderen.

 

Resten van behandeld zaad nooit verspreiden of vervoederen aan dieren.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

 

B.

GEBRUIKSAANWIJZING

 

Toepassingen

 

Suiker- en voederbieten, ter voorkoming van plantuitval door aantasting door bietenkevertjes (Atomaria linearis)

Dosering:

60 ml middel per 100.000 zaden

 

Het middel uitsluitend toepassen bij het pilleren van zaden van suikerbieten en voederbieten.

 

 

 


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 17 december 2008 tot toelating van het middel Force, toelatingnummer 13135 N

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        2

 

2.   Physical and chemical properties                  3

 

3.   Methods of analysis                                         8

 

4.   Mammalian toxicology                                      11

 

5.   Residues                                                            17

 

6.   Environmental fate and behaviour                22

 

7.   Ecotoxicology                                                    34

 

8.   Efficacy                                                               47

 

9.   Conclusion                                                        50

 

10. Classification and labelling                             50

 


1.         Identity of the plant protection product

 

1.1       Applicant

Syngenta Crop Protection B.V.

Jacob Obrechtlaan 3a

4600 AM  Bergen op Zoom

Nederland

 

1.2       Identity of the active substance

Common name

tefluthrin

Name in Dutch

tefluthrin

Chemical name

[IUPAC]

2,3,5,6-tetrafluoro-4-methylbenzyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
or
2,3,5,6-tetrafluoro-4-methylbenzyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

CAS no

79538-32-2

EEG no

Not allocated

 

The active substance is not included in Annex I of directive 91/414/EEC. A draft assessment report (DAR) of tefluthrin is available (RMS: Germany). NL has commented on the DAR; a reporting table is not yet available.

 

1.3       Identity of the plant protection product

Name

Force

Formulation type

CS *

Content active substance

200 g/L pure tefluthrin

* The codes CS and FS are both used for this application. For the risk assessment these codes are not considered vital information and are considered interchangeable.

 

The formulation is identical to that under assessment for the inclusion of the active substance in Annex 1 of directive 91/414/EEC.

 

1.4       Function

Insecticide for seed treatment.

 

1.5       Uses applied for

Force is claimed as an insecticide for the control of the pygmy mangold beetle (Atomaria linearis) in sugar beets and fodder beets by means of a seed treatment.

The proposed dose rate is 60 ml product per unit of 100,000 seeds.

Uses

Dose a.s.

(g a.s./ha)

Number of applications

Interval between applications

Application time (growth stage and season)

Pygmy mangold beetle:

sugar- and fodder beet

 

 

15.6

 

1 (seed treatment)

 

not applicable

 

Seed

(Feb-May)

 

 

 

 

 

* 12 ml a.s. per 100.000 seeds, max. 130.000 seeds per ha.

 

1.6       Background to the application

It concerns an application for an authorization of an insecticide used for seed treatment.

 

As a consequence of the European assessment of the active substance in the light of the decision whether it can be placed upon Annex I of Directive 91/414/EEC or not, a concept for a monograph has been conceived. The Ctgb has evaluated this concept-monograph and has given comments upon its contents. With full consideration of these comments, the Ctgb has made the contents of the concept-monograph her own and applies them in the handling of the present application. In the List of Endpoints underneath, the Dutch comments are typed in italics.

 

1.7       Packaging details

1.7.1    Packaging description

Material:

HDPE

Capacity:

1, 5 or 20 L

Type of closure and size of opening:

45 or 63mm opening with screw cap closure and heat seal or compression wad and tamper evident ring.

Other information

UN/ADR compliant.

 

PET is also proposed as packaging in document M-III. However, only HDPE is mentioned on the application form. Suitability of packaging has only been displayed for HDPE, not for PET.

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.      Physical and chemical properties

 

2.1              Active substance: tefluthrin

Data on the identity and the physical and chemical properties is taken from the List of Endpoints (volume 1, DAR, August 2006). Changes and/or additions are taken up in italics.

 

Identity

Active substance (ISO Common Name)

tefluthrin

Chemical name (IUPAC)

2,3,5,6-tetrafluoro-4-methylbenzyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
or
2,3,5,6-tetrafluoro-4-methylbenzyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

Chemical name (CA)

(2,3,5,6-tetrafluoro-4-methylphenyl)methyl (1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyclopropanecarboxylate

CIPAC No

451

CAS No

79538-32-2

EEC No (EINECS or ELINCS)

not available

FAO Specification (including year of                                publication)

not available

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

900 g/kg, open point *

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

no relevant impurities

Molecular formula

C17H14ClF7O2

Molecular mass

418.7 g/mol

Structural formula

 

 

* according to the RMS the specification should be amended. Although NL agrees on the data requirement, a new specification will not influence the risk assessment for the national authorisation of Force. The issue will be resolved in the EU.

 

Physical-chemical properties

Melting point (state purity)

44.6 °C (99.1 %)

Boiling point (state purity)

156 °C at 1 mm Hg (99.1 %)

Temperature of decomposition

295 °C (99.1%)

Appearance (state purity)

white solid (99.1 %)

off-white solid with no characteristic odour (94.9%)

Relative density (state purity)

d = 1.48 g/cm3 (94.1 %)

Surface tension

Not required; water solubility < 1 mg/L

Vapour pressure (in Pa, state temperature)

8.4 x 10-3 Pa at 20 °C

2.1 x 10-2 Pa at 30 °C

5.1 x 10-2 Pa at 40 °C

Henry’s law constant (in Pa·m3·mol-1)

2 x 102 Pa m3 mol-1 at 20 °C

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

0.016 mg/L at 20 °C (99.1 %)

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

Solubility at 21 °C:

acetone                                  > 500 g/L
dichloromethane                    > 500 g/L
toluene                                   > 500 g/L
ethyl acetate                           > 500 g/L
hexane                                   > 500 g/L
methanol                                262 g/L           

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

6.4 at 20 °C (99.1 %), pH not stated

Hydrolytic stability (DT50) (state pH and temperature)

pH 5:   stable at 25 °C up to 30 d

pH 7:   stable at 25 °C up to 30 d

pH 9:   28 % hydrolysed after 30 d (25 °C)

Dissociation constant

considered not relevant

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

e = 25400 L.mol-1.cm-1(l = 211.7 nm)

e = 1190 L.mol-1.cm-1(l = 268.3 nm)

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

11.2 d (equivalent Florida summer sunlight)

at 25 °C and pH 7

Quantum yield of direct photo-

transformation in water at λ > 290 nm

not applicable, for e < 10 L/(mol cm) at 290 nm

Photochemical oxidative degradation in air

kOH = 17,0 x 10-12 cm3 molecules-1 s-1

[OH] = 1.5 x 106 molecules cm-3

DT50 = 7.5 h

Flammability

not considered highly flammable

Auto-flammability

440 oC (92.6%)

Oxidative properties

Not oxidising (theoretical assessment)

Explosive properties

not considered an explosive in the sense of EEC Method A.14

 

2.2              Plant protection product: Force

The product Force is not diluted before use. A minimum and maximum spray concentration do not need to be calculated.

 

Some studies are based on the formulation YF11853 (200 g/L tefluthrin FS). This formulation is identical to Force.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP

Visual

Slightly viscous liquid

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP

Visual

Opaque beige

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP

Olfactory

Weak, aromatic, solvent-like

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

Theoretical assessment

Not explosive based on the individual components of the formulation Force.

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

Theoretical assessment

Not oxidising based on the individual components of the formulation Force.

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable to CS formulations

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP

EC A15

> 400 oC

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP

EC A9

Force does not flash before it reaches it’s boiling point

(~101 oC)

Acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

GLP

CIPAC MT31.2.1

After storage at 25 oC for 2 years: 0.439%w/w (NaOH)

Acceptable; before storage the pH was 9.53; after storage (2 years at 25 oC) 10.07.

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC MT75

Neat: 9.53

1% in distilled water: 9.00

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP

EC A5

1% in water: 65 mN/m

Acceptable; classification with Xn/R65 is not required based on the high viscosity of Force.

B.2.2.12 (IIIA 2.5)

Viscosity

GLP

6.94x103 mPa.s (20 oC)

4.44x103 mPa.s (40 oC)

Acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP

EC A3

D420 = 1.06

Acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable to CS formulations

 

B.2.2.15 (IIIA 2.7)

Storage stability

GLP

CIPAC MT46

 

 

 

 

 

 

GLP

CIPAC MT39

Stable for 8 weeks at 40 oC in HDPE

 

Properties determined before and after storage: appearance, packaging stability, a.i. content, pH, wet sieve residue, viscosity, weight loss.

 

Stable for 7 days at 0 oC

 

Properties determined before and after storage: appearance.

Acceptable; the product is stable at low temperatures and at accelerated storage conditions in HDPE.

B.2.2.16 (IIIA 2.7)

Shelf life

GLP

Stable for 2 years at 25 oC in HDPE.

 

Properties determined before and after storage: appearance, packaging stability, a.i. content, pH, weight change, pourability, wet sieve residue, viscosity, pH (1% and neat).

 

After storage the alkalinity was determined because the pH of a 1% dispersion surpassed the threshold of pH 10.

 

Adherence and distribution over seeds was not determined after storage, but this is not considered necessary because the product does not show any significant change in any of the physical or chemical properties determined after storage.

Acceptable; Force has a shelf life of 2 years in HDPE.

B.2.2.17

(IIIA 2.8)

Wettability

 

Not applicable to CS formulations

 

B.2.2.18 (IIIA 2.8)

Persistent foaming

 

 

Not required; the product is not diluted before use.

B.2.2.19

(IIIA 2.8)

Suspensibility

 

 

Not required; the product is not diluted before use.

B.2.2.20

(IIIA 2.8)

Spontaneity of dispersion

 

 

Not required; the product is not diluted before use.

B.2.2.21

(IIIA 2.8)

Dilution stability

 

Not applicable to CS formulations

 

B.2.2.22

(IIIA 2.8)

Dry sieve test

 

Not applicable to CS formulations

 

B.2.2.23

(IIIA 2.8)

Wet sieve test

GLP

CIPAC MT59.3

0.0236% on a 75 μm sieve

Acceptable

B.2.2.24

(IIIA 2.8)

Particle size distribution

 

Not applicable to CS formulations

 

B.2.2.25

(IIIA 2.8)

Content of dust/fines

 

Not applicable to CS formulations

 

B.2.2.26

(IIIA 2.8)

Attrition and friability

 

Not applicable to CS formulations

 

B.2.2.27 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable to CS formulations

 

B.2.2.28

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable to CS formulations

 

B.2.2.29

(IIIA 2.8)

Flowability

 

Not applicable to CS formulations

 

B.2.2.30

(IIIA 2.8)

Pourability (rinsibility)

GLP

CIPAC MT148

Residue: 6.44%

Rinsed residue 0.361%

Acceptable

 

Although the formulation has a high pour residue, this is considered acceptable for this product. The product. There are instructions available for safe disposal of waste.

B.2.2.31

(IIIA 2.8)

Dustability

 

Not applicable to CS formulations

 

B.2.2.32

(IIIA 2.8)

Adherence and distribution to seeds

GLP

CIPAC MT175

Seed to seed uniformity had a relative standard deviation of 16.9%.

Acceptable

 

 

GLP

Tests for Retention of Powders (Jeffs, K.A. (1974))

2 ml of formulation was added per 100 g seed in a laboratory scale seed treatment machine, dried and sieved

 

Retention (determined by GC-FID assay) of the test material on cereal has been determined as 95.6%

Acceptable

2.9.1

Physical compatibility with other products

 

Not applicable; no mixing proposed

 

2.9.2

Chemical compatibility with other products

 

Not applicable; no mixing proposed

 

 

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

 

Conclusion

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

 

The shelf life of the plant protection product Force is 2 years in HDPE packaging.

 

2.3       Data requirements

None.

 

 

3.      Methods of analysis

Description and data on the analytical methods is taken from the List of Endpoints (Volume 1, DAR, August 2006). 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)

GC/FID

Impurities in technical as (principle of method)

GC/FID

Preparation (principle of method)

GC/FID

 

Method SF-28/1 (HPLC-UV) for determination of tefluthrin in Force.

 

Conclusion

The analytical methods regarding the technical active ingredient and the formulation have been assessed in the DAR and are considered to be acceptable. In addition, the applicant has provided a second fully validated method for determination of the active substance in the formulation, which will replace the GC-FID method.

 

3.2       Residue analytical methods

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

GC-MS            0.01 mg/kg (maize grain, maize straw, sugar beet roots, sugar beet leaves with tops, oranges, oil seed rape)

Confirmatory method: 3 mass fragments

ILV: yes

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

Not required; no MRL proposed

Soil (principle of method and LOQ)

GC-MS            0.01 mg/kg
GC-ECD         0.05 mg/kg

Confirmatory method: GC-MS with 3 mass fragments

Water (principle of method and LOQ)

GC-MS            0.0002 µg/L (tap and surface water)

Confirmatory method: 3 mass fragments

Air (principle of method and LOQ)

GC-MS            0.15 µg/m3

Confirmatory method: 3 mass fragments

Body fluids and tissues (principle of method and LOQ)

GC-MS            0.002 mg/kg (tissue)
GC-ECD         0.005 mg/kg (tissue)

Confirmatory method: GC-MS with 3 mass fragments

 

GC-MS           0.05 mg/L (human and dog blood plasma)

Confirmatory method: 3 mass fragments

 

Based on the proposed use of the plant protection product analytical methods for determination of residues in food/feed of plant origin require specific validation for sugar beets (crop specific matrix).

 

The EU evaluation of the active substance includes residue analytical methodology for plant material and therefore the EU evaluation is adopted. Sugar beets are thoroughly processed and therefore no relevant residues are expected.

 

Definition of the residue and proposed MRL’s for tefluthrin

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

Tefluthrin

0.02 mg/kg (sugar beet)

Food/feed of animal origin

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

 

Required LOQ

Soil

Tefluthrin

0.05 mg/kg (default)

Drinking water

Tefluthrin

0.1 µg/L (Dutch drinking water guideline)

Surface water

Tefluthrin

0.1 µg/L

Air

Tefluthrin

0.45 µg/m3 (derived from the AOEL (0.0015 mg/kg bw/day) according to SANCO/825/00)

Body fluids and tissues

Tefluthrin

0.05 mg/l (blood)

0.1 mg/kg (tissues; meat or liver)

 

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

 

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

 

Conclusion

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

 

3.3       Data requirements

None.

 

3.4       Physical-chemical classification and labelling

 

Proposal for the classification of tefluthrin (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 Force 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 for professional use only:

 

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

21

When using do not smoke.

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

The shelf life of the plant protection product Force is 2 years in HDPE packaging.

 


 

4.      Mammalian toxicology

 

List of Endpoints

The toxicological profile presented below is based on the Draft Assessment Report (DAR) prepared by the RMS Germany. The Dutch comments on the DAR and some additional information, where relevant, are also presented (in italic). Since the active substance is still in the process of evaluation/discussion, the toxicological profile below should be regarded as provisional. The process of evaluation just started; Member States commented on the DAR in July 2007 and tefluthrin has not yet been discussed in an Evaluation Meeting.

 

Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)

Rate and extent of absorption

Approximately 30 %, based on urinary excretion

Distribution

Widely distributed, Highest residue levels in liver

Potential for accumulation

No potential of accumulation.

Rate and extent of excretion

Approximately 90 % within 48 h, approximately two third in faeces and one third in urine

Metabolism in animals

Extensively metabolised, oxidation of aliphatic groups in the acid and alcohol moieties, ester cleavage

Toxicologically significant compounds

(animals, plants and environment)

Parent compound; major metabolites in plants were found in mammals also, their toxicity has been evaluated in toxicity studies

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

21.8 mg/kg bw (m), 34.6 mg/kg bw (f)

Rat LD50 dermal

177 mg/kg bw (f), 316 mg/kg bw (m)

Rat LC50 inhalation

0.037 mg/L (f), 0.049 mg/L (m), (4h, nose only)

Skin irritation

Slightly irritating, no classification

Eye irritation

Slightly irritating, no classification

Skin sensitisation (test method used and result)

Non sensitising (M&K Test)

 

Short-term toxicity (Annex IIA, Point 5.3)   

Target/critical effect

bw gain decreased in rats and dogs, nervous system (tremor, ataxia) and thyroid (increased organ weight) in dogs

Lowest relevant oral NOAEL / NOEL

Dog, 13 weeks: 0.5 mg/kg bw/day

Dog, 52 weeks: 0.5 mg/kg bw/day

Rat, 13 weeks: 150 ppm (13.6 mg/kg bw/day)

Lowest relevant dermal NOAEL / NOEL

Rat, 21 day: 1.0 mg/kg bw/day (skin effects) 1; 50 mg/kg bw/day (systemic toxicity)

Lowest relevant inhalation NOAEL / NOEL

No data

1NL comments on DAR: It is not explained why the signs of paraesthesia are not considered substance-related effects. They are disregarded even for the NOEL, although it also occurs in humans. Even if it is reversible within a day, it should be considered adverse. NL proposes a NOAEL: 0.1 mg/kg bw/d.

 

Genotoxicity (Annex IIA, point 5.3)

No evidence of genotoxicity 2

2  The genotoxic potential of tefluthrin was investigated in five in vitro studies (two Ames tests, mammalian gene mutation test, mammalian cytogenetic test in human lymphocytes, mammalian cell DNA repair test in primary rat hepatocytes) and in two in vivo studies (micronucleus test in mouse bone marrow, cytogenetic test of bone marrow of rats). All tests were negative.

 

Long-term toxicity (Annex IIA, point 5.5)    

Target/critical effect

bw gain, food consumption, symptoms of nervous system, liver (clinical chemistry, organ weight, histology)

Lowest relevant NOAEL/NOEL

Rat, 2 yr: 25 ppm (1.5 mg/kg bw/day)

Mouse, 2 yr: 25 ppm (3.2 mg/kg bw/day)

Carcinogenicity

No evidence of carcinogenicity in rats and mice.

 

Reproductive toxicity (Annex IIA, point 5.6)          

Reproductive target /critical effect

Reduced total litter weight and pup weight gain, neuro-logical symptoms (abnormal gait, shaking)

Lowest relevant reproductive NOAEL / NOEL

50 ppm (4.7 mg/kg bw/day) (parental)

50 ppm (4.7 mg/kg bw/day) (fertility)

15 ppm (1.4 mg/kg bw/day) (offspring) 3

3 In the reproduction study neurotoxic effects (abnormal gait, shaking) were observed at the high dose with increased severity in the subsequent generations. In F2A en F2B the effects were also observed at the mid dose, without parental effects. However these effects are observed mainly after PND 22, when the pups are eating the diet.

NL comments on DAR: As the NOAELdevelopmental is lower than the NOAELparental, why is no classification proposed by the RMS?

 

Developmental toxicity

Developmental target/critical effect

Slight reduction of ossification in rats, increased incidence of 25 pre-sacral vertebrae in rats and of 27 pre-sacral vertebrae in rabbits, no evi­dence of teratogenicity

Relevant maternal NOAEL

1 mg/kg bw/day

Relevant developmental NOAEL

Rat: 3 mg/kg bw/day

Rabbit: < 3 mg/kg bw/day

 

Neurotoxicity/ delayed neurotoxicity (Annex IIA, point 5.7)

Acute delayed neurotoxicity, Domestic Hen

Single dose at 3605 mg/kg bw: no clinical signs, mild histological findings (minimal axonal degeneration of spinal cord without damage to the sciatic or tibial nerves)

Acute neurotoxicity, Rat

Decreased landing foot splay, increased breathing rate, increased for-limb grip strength; NOEL: 2.5 mg/kg bw/day

Subchronic neurotoxicity, Rat

90 day: increased landing foot splay, NOEL: 150 ppm (11.6 mg/kg bw/day)

 

Other toxicological studies (Annex IIA, point 5.8)

 

No studies, not necessary 4

4 NL comments on DAR: Since tefluthrin is a pyrethroid, the necessity of a developmental neurotox study should be considered.

 

Medical data (Annex IIA, point 5.9)

 

Reports of paraesthesia (facial, forearms, eyes)

 

Summary (Annex IIA, point 5.10)

 

Value

Study

Safety factor/OA

ADI

0.005 mg/kg bw

Dog, 1 yr

100

AOEL systemic

0.0015 mg/kg bw/day

Dog, 90 d and 1 yr

100/30%

ARfD (acute reference dose)

0.005 mg/kg bw 5

Dog, 90 d

100

OA = oral absorption

5 NL comments on DAR; the most appropriate effect after an acute dose should be taken, hence the RMS should explain why they prefer the 13-w dog study (effects seen after 4 days of dosing) and not the acute neurotox study (effects -at 5 mg/kg- after single dose).

 

Dermal absorption (Annex IIIA, point 7.3)

                                         

CS (microencapsulated) formulation, representative of formulation YF11853, which contains a nominal 200 g tefluthrin/1: 0.12 % absorption

 

Data requirements active substance

The data requirements identified in the EU-assessment are also applicable to the Dutch assessment.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Force does not need to be classified on the basis of its acute oral (LD50 rat >2000 mg/kg bw), and dermal toxicity (LD50 rat >2000 mg/kg bw).

 

The acute inhalation toxicity study was performed with a 300 g/L CS formulation (LC50 rat >2.85 mg/L highest attainable) On the basis of the differences in active ingredient concentration the applicant predicted for Force 20 CS (A-13219F) a median lethal concentration (LC50) in excess of 3 – 4 mg/L air and proposed classification/labelling with R 20 (harmful by inhalation). Considering the high inhalation toxicity of the active ingredient tefluthrin (LC50 = 0.043 mg/L air; 4h) the proposed classification/labelling is recommended.

 

The formulation Force does not need to be classified for dermal and eye irritation.

 

The formulation Force is positive in a Buehler test for skin sensitisation and needs to be classified as R43 ‘May cause sensitisation by skin contact’.

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

See List of Endpoints. The in vitro and in vivo dermal absorption studies were performed with the formulation Force 20 CS.

 

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

Other formulants: no reason for toxicological concern.

 

4.4       Exposure/risk assessments

Overview of the intended uses

Force is a flowable concentrate for seed treatment (FS) formulation and contains 200 g/L tefluthrin.

 

The formulation Force is used as a seed treatment; seeds are treated in a closed system and the seeds are planted mechanically.

The formulation is applied once on the seeds at a maximum dose rate of 60 mL formulation / 100.000 seeds. As the treatment of seed units is a continuous process which is performed by a specialized company, a chronic exposure duration is applicable for the operator. As the seeds are treated in a closed system and planting of the seeds is done mechanically, only the internal operator exposure during mixing and loading of the formulation was estimated.

 

The applicant provided the following information:

The maximum pelleting capacity of a large facility is estimated to be 5000 units/day (1 unit is equivalent to 100,000 seeds = approx. 3.5 kg). The amount of active ingredient handled will be 60 kg/day.

 

Treatment and pelleting of sugar beet seed takes place in closed systems (fluid bed coaters or rotary drum coaters or granulators) and is a fully automated process. After the application of the chemical containing slurry a final coloured filmcoat is applied to the seeds. This highly resistant surface prevents abrasion during transport, storage and loading/sowing. It also avoids dust formation during the final drying step, during emptying the treaters, and during packaging of treated seed.

 

Dosage of the chemicals is based on the amount of seed to be treated; there is no manual calibration such as measuring a slurry volume pumped per time unit.

 

Loading of liquid products is done in different ways and largely depends on the container size and design: small containers of 20 litres may be emptied manually or by a means of suction probe into a mixing tank, loading from 200 litre drums is usually done via probe, pipe and pump, and 1000 litre containers are usually directly connected to the treater.

 

Pelleted sugar beet seed is normally packed into boxes of 1 unit each, i.e. 3.5 kg seed/box. Packing is fully automatic, with operator activities basically being limited to supplying the machine with stocks of packing material and to transporting pallets of packed seed to the storage room.

 

Cleaning of equipment is partly automatic. Where manual cleaning is involved this is normally done by wiping or with pressurised water.

 

Calculation of the AOEL

Since a chronic exposure for operators cannot be excluded, a systemic AOEL for chronic exposure will be derived, and will be based on the NOAEL of 0.5 mg/kg bw/d in the 1-year study in dog. Application of a safety factor of 100 and an oral absoption of 30% results in a chronic AOEL of 0.0015 mg/kg bw/day (= 0.105 mg/day for a 70-kg operator).

 

4.4.1    Operator exposure/risk

As the seeds are treated in a closed system and planting of the seeds is done mechanically, only the internal operator exposure during mixing and loading of the formulation was estimated. As indicated by the applicant, manual loading will only be performed with the 20L container. Therefore it will be assumed as a worst-case situation that 1 container of 20L is used per day. If larger volumes of seed need to be treated, larger containers (200L, 1000L) will be used, for which exposure is assumed to be much lower that for manual pouring.

 

Exposure to tefluthrin during mixing and loading of Force is estimated with models. The exposure is estimated for the unprotected operator. In Table 1 the estimated internal exposure is compared with the systemic AOEL.

 


Table T.1 Internal operator exposure to tefluthrin and risk assessment for the use of Force

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Manual loading

Mixing/

Loading

Respiratory

0.02

0.105

0.19

Dermal

0.096

0.105

0.91

 

Total

0.116

0.105

1.10

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

·       biological availability via the dermal route:   0.12% (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.

 

There are no appropriate models to estimate operator exposure during cleaning activities recommended by the applicant. Cleaning is partially done automatically; when cleaning manually the use of PPE (gloves, coverall, and face protection) will prevent a significant exposure, hence no risk is anticipated in that case.

 

4.4.2    Bystander exposure/risk

Bystanders should not be present during seed treatment with Force or during the loading/sowing of treated seed.

 

4.4.3    Worker exposure/risk

As the only use of Force is treating seeds prior to sowing, no re-entry scenario is envisaged.

 

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 meets the standards.

 

Operator exposure

For the unprotected operator, adverse health effects after dermal and respiratory exposure to tefluthrin as a result of the application of Force in the seed treatment of sugar and fodder beet cannot be excluded. Correct use of personal protective equipment can reduce the dermal exposure by a factor of 10. This results in a sufficient reduction of the exposure to tefluthrin for the application of Force in seed treatment of sugar and fodder beet. Even though the above risk assessment indicates only a rather small risk for the unprotected operator, the used model is not specifically tailored for seed treatment and the applicant indicates that protective equipment should be used during seed treatment process and when handling treated seeds. Moreover, to minimise the potential for paraesthesia (an effect of the active substance), the skin including the face should be protected, hence gloves, protective clothing and a face protection should be worn when handling the concentrate and dilution, e.g. during manual cleaning.

 

Bystander exposure

Bystanders should not be present during seed treatment with Force or during the loading/sowing of treated seed.

 

Worker exposure

As the only use of Force is treating seeds prior to sowing, no re-entry scenario is envisaged. Sowing is done automatically, however, when filling the sowing machine there could be a potential exposure, although the seed are coated. The applicant indicates that: “Seed treated with Force 20 CS should never be handled without gloves.” The DAR indicates that gloves should be worn “to eliminate any risk of facial skin sensation from hand to face contact”.

 

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

Force 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:

T+

Indication of danger: Very toxic

 

Risk phrases

R24

Toxic in contact with skin.

 

R26/28

Very toxic by inhalation and if swallowed.

 

Proposal for the classification and labelling of the formulation concerning health

 

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

 

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

-

Symbol:

Xi

Indication of danger:

Irritating

R phrases

R43

May cause sensitisation by skin contact

 

R67

Vapours may cause drowsiness and dizziness

S phrases

S36/37/39b

Wear suitable protective clothing, gloves and face protection.

 

S37e-NL

Wear suitable gloves when handling treated seeds

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:

Xn us not obligatory in combination with the assigned R-phrases.

Risk phrases:

R20 is not considered necessary, since based on the application method and vapour pressure, of the active substances respiratory exposure will be negligible.

R67 is assigned based on the amount of one of the coformulants

Safety phrases:

S2, S13, S20 are not obligatory for formulations intended for professional use only.

S21 is not considered necessary, since based on the application method and water solubility, vapour pressure, log Pow and Henry’s law constant for the relevant (co-) formulants, respiratory exposure will be negligible.

The Ctgb only assigns S35 to preparations with hazard-symbol T+, T, or C with respect to the toxicological aspect of the preparation in question.

S36/37/39b and S37e-NL are assigned instead of S36/37, based on the risk assessment for the operator and worker exposure.

S46 is not compulsory in combination with the assigned risk-phrases.

Other:

-

 

 

5.      Residues

Tefluthrin is an existing active substance, not included in Annex I of directive 91/414/EEC. The evaluation is based on the Draft Assessment Report, the first version of the List of Endpoints completed with the Dutch comments on the Draft Assessment Report.

 

List of Endpoints

 

Residues

 

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

root and tuber vegetables (sugar beet), cereals (maize)

Rotational crops

wheat, soybean, lettuce, sugar beet

Metabolism in rotational crops similar to metabolism in primary crops?

widely similar, however, some differences are highlighted:

-          one additional metabolite in soybean foliage (compound XII)

-          compound IV occurred in higher amounts in succeeding wheat and soybeans (up to 64.5 %) than in primary crops sugar beet and maize

Processed commodities

not applicable

Residue pattern in processed commodities similar to residue pattern in raw commodities?

not applicable

Plant residue definition for monitoring     *

tefluthrin

Plant residue definition for risk assessment                                                                *

tefluthrin

Conversion factor (monitoring to risk assessment)

not applicable

* In maize leave, sugar beet foliage as well as in soybean foliage and wheat straw resulting from crop rotation, metabolites VI and IV and XI and 1a might occur in detectable amounts at harvest. Since these molecules contain key moieties of the original tefluthrin molecule, their toxicology might be of concern for consumers or livestock. According to the Netherlands, the residue definition should also contain these metabolites.

 

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

Animals covered

lactating goat

Time needed to reach a plateau concentration in milk and eggs

Milk: 3 days (metabolism study with goats), 5 days (feeding study with dairy cows)

 

eggs: not applicable

Animal residue definition for monitoring

not required

Animal residue definition for risk assessment

not required

Conversion factor (monitoring to risk assessment)

not applicable

Metabolism in rat and ruminant similar (yes/no)

yes

Fat soluble residue: (yes/no)

no

 

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

crops: wheat, soybean, lettuce and sugar beet

rotation intervals: 1, 4 and 12 months

Residues in edible parts of succeeding crops (wheat grain, lettuce, soybean, sugar beet) are not likely to exceed 0.01 mg/kg when grown after tefluthrin-treated sugar beet. Residues in feeding commodities derived from succeeding crops (wheat straw, soybean foliage, sugar beet foliage) are not likely to exceed 0.1 mg/kg when grown after tefluthrin-treated sugar beet.

 

 

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

 

Tefluthrin: stable for up to 24 months at -18°C in maize (fodder, forage and kernels), sugar beet roots, soybeans and broccoli

Compounds Ia and VI: stable in maize and sugar beet for 11–22 months at -18 °C, high variation of results

 

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

 

Ruminant

Poultry

Pig

Intakes by livestock ł 0.1 mg/kg diet/day (yes/no)

no

no

no

Residues in animal matrices (data from low dose group feeding study with dairy cows: 0.3 mg/kg diet tefluthrin + 0.2 mg/kg diet R173204)

Milk:        tefluthrin max. 0.003 mg/kg, PP890                and R173204 < 0.01 mg/kg each

Muscle: tefluthrin < 0.002 mg/kg, PP890 and                R173204 < 0.01 mg/kg each

Fat:         tefluthrin 0.003-0.01 mg/kg, PP890                and R173204 < 0.01 mg/kg each

Liver:      tefluthrin < 0.002 mg/kg, PP890 and                R173204 < 0.01 mg/kg each

Kidney:   tefluthrin < 0.002 mg/kg, PP890 and                R173204 < 0.01 mg/kg each

The low dose from the study is still sixfold overdosed compared with the maximum calculated dietary burden.

 

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

Crop/processed crop

Number of trials

Transfer factor

% Transference*

 

not required

 

 

* Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies

 

Comments on/additions to List of Endpoints

 

5.1       Summary of residue data

 

5.1.1    Metabolism in plants

Metabolism was investigated in root and tuber vegetables (sugar beet) and in cereals (maize) after soil treatment with 14C-labelled phenyl or cyclopropane tefluthrin. Residues are low in sugar beet root (all metabolites). However, in maize leaves, sugar beet foliage as well as in soybean foliage and wheat straw resulting from crop rotation, metabolites VI and IV and XI and 1a might occur in detectable amounts at harvest. Since these molecules contain key moieties of the original tefluthrin molecule, their toxicology might be of concern for consumers or livestock.

 

5.1.2    Metabolism in livestock

Metabolism was investigated in lactating goat. However, since no residues above the LOQ of 0.01* mg/kg are expected in beet root or beet foliage, no residue definition was derived in the draft assessment report.

 


5.1.3    Residue definition (plant and animal)

plants

Tefluthrin parent is only found in detectable amounts directly after application. Metabolites VI and IV and XI and 1a might occur in detectable amounts at harvest in maize and beet foliage, but not in sugar beet roots. Since these molecules contain the key moieties of the original tefluthrin molecule, their toxicology might be of concern. The Netherlands commented on the draft assessment report that these metabolites might be better marker molecules than tefluthrin.

However, for the current authorisation request, only the residue behaviour in sugar beet root is of importance for MRL setting. Therefore, the proposed residue definition for monitoring as well as risk assessment, parent tefluthrin, fulfils for sugar beet root, which is in accordance with the Dutch Regeling Residuen.

 

animals

Since no residues of tefluthrin parent are expected above the LOQ of 0.01* mg/kg in beet root or beet foliage, no residue definition was derived in the draft assessment report. NL commented on this that that metabolites VI and IV and XI and 1a might occur in detectable amounts at harvest in beet foliage or rotational crops, and these metabolites should be included in the dietary intake calculation for ruminants.

 

5.1.4    Stability of residues

Tefluthrin residues were found to be stable at -18oC for up to 11 month in maize kernel (dry matrix), maize fodder and forage and broccoli (watery matrix), in soybean (fatty matrix) and in sugar beet root (special matrix).

 

5.1.5        Residue data

Sugar beet

Nineteen residue trials were performed in Northern Europe within 25% deviation from GAP-NL. Residue levels found were:

roots:   < 0.01 (18); 0.02 mg/kg. STMR = 0.01, HR = 0.02 mg/kg

foliage: < 0.01 (17) mg/kg.

 

In 6 trials performed in Northern Europe, also residues of compounds Ia and VI were measured and were found to be:

root: 6x< 0.01 mg/kg;

foliage: 6x<0.01 mg/kg.

 

5.1.6        Residues in succeeding crops

Uptake and metabolism was investigated in a confined rotational crop study with lettuce, sugar beet, soybean and wheat.  Residues in edible parts of succeeding crops (wheat grain, lettuce, soybean, sugar beet) are not likely to exceed 0.01 mg/kg TRR when grown after tefluthrin-treated sugar beet. Residues in feeding commodities derived from succeeding crops (wheat straw, soybean foliage, sugar beet foliage) are not likely to exceed 0.1 mg/kg TRR when grown after tefluthrin-treated sugar beet (See list of Endpoints). The intake of residues by livestock is not expected to exceed 0.1 mg/kg dry feed.

 

5.1.7    Residues from livestock feeding studies

Since no residues of tefluthrin parent are expected above the LOQ of 0.01* mg/kg in beet root or beet foliage, no residue definition was derived in the draft assessment report. NL commented on this in a way that also metabolites VI and IV and XI and 1a occur in detectable amounts at harvest in beet foliage or rotational crops and should be included in the dietary intake calculation for ruminants.

However, since all individual metabolite levels are low and total residues in livestock feed derived from crops, which have been planted or sown 4 and 12 months after tefluthrin treatment, will most likely be below 0.1 mg/kg. This issue will be solved during the European evaluation of tefluthrin, which is also based on seed treatment of sugar beets.

 

5.1.8    Processing factors

Since no residues above the LOQ of 0.01* mg/kg are expected in beet root, no residue processing studies were required.

 

5.1.9    Calculation of the ADI and the ARfD

The ADI is based on the NOAEL of 0.5 mg/kg bw/d from the 1y oral dog study based on ataxia and tremors at 2 mg/kg bw/d. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.005 mg/kg bw/day (see also the comments on the List of Endpoints in the section 4. Human Toxicology of this assessment).

 

The ARfD is based on the NOAEL of 0.5 mg/kg bw/d from the 13w oral dog study based on body tremors on day 4 at 1.5 mg/kg bw/d. Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD of 0.005 mg/kg bw/day (see also the comments on the List of Endpoints in the section 4. Human Toxicology of this assessment).

 

It is stressed that this ADI and ARfD do not cover possible neurotoxicology effects for young children since a proper developmental neurotoxicological study still was not provided, required for all synthetic pyrethroids after discovery of possible neurotoxicological effects for some pyrethroids (e.g. deltamethrin).

 

5.2       Maximum Residue Levels

MRLs have been set so far nationally: 0.05* mg/kg (all crops). The product complies with the directive (Regeling Residuen).

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

Based on the proposed residue tolerances, a calculation of the National Theoretical Maximum Daily Intake (NTMDI) was carried out using the National Dutch diet and the HR of 0.02 mg/kg. Calculation of the NTMDI shows that <1% and 1.7% of the ADI is used for the general population and for children, respectively.

 

It is stressed that the ADI is based on a toxicological data package without an acceptable developmental neurotoxicology study. For the current authorisation request only seed treatment of sugar beet is of interest. STMRs of 0.01 mg/kg for sugar beet result in  <1 % of the ADI for the general population and for children, respectively. For (sugar) beet, intake of residues is expected to be essentially near zero. Therefore, in view of the very low intake of residues after seed treatment of sugar beet, for the current authorisation request no risk is expected for young children during the development of their neurological system.

 

Risk assessment for acute exposure through diet

A calculation of the National Estimated Short Term Intake (NESTI) was carried out using the National Dutch diet (‘large portion sizes’; 97.5 percentile from dietary data), the UK ‘unit weights’ and previously mentioned temporary EU-MRL for potato and an STMR of 0.01 mg/kg for sugar beet. The NESTI uses 0.6% and 1.9% of the ARfD for the general population and for children, respectively.

 

It is stressed that the ARfD is based on a toxicological data package without an acceptable developmental neurotoxicology study. For the current authorisation request only the seed treatment of sugar beet is of interest. For (sugar) beet, intake of residues is expected to be essentially near zero. Therefore, in view of the very low intake of residues after seed treatment of sugar beet, for the current authorisation request no risk is expected for young children during the development of their neurological system.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to tefluthrin is currently expected. The product complies with the Uniform Principles.

 

5.4              Data requirements

None.

 

 

6.                  Environmental fate and behaviour

 

The DAR (RMS Germany) will be used as basis for the assessment, together with the Dutch comments on the DAR (added in italic to the List of Endpoints). No additional (formulation) data have been provided, since the proposed use and the formulation matches the intended use in the DAR.

A former authorisation of Force in The Netherlands was withdrawn in 1999. Since now a DAR is available, the data and the risk assessments belonging to this earlier authorisation are not taken into account in the current assessment.

 

List of Endpoints Fate/behaviour  (August 2006)


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

Mineralisation after 100 days

 

 20.7 –65.3 % after 90-94 d [U-14C]-Phenyl-tefluthrin labelled

52.2 % after 94 d [U-14C]-Cyclopropyl-tefluthrin labelled

Non-extractable residues after 100 days

 

5.2 –22.4 % after 118 d, [U-14C]-Phenyl-tefluthrin labelled

17.1  % after 94 d, [U-14C]-Cyclopropyl -tefluthrin labelled

Metabolites requiring further consideration
- name and/or code, % of applied (range and maximum)

Compound Ia (R119890) was formed in amounts > 5 % (max. 7.1 % after 31 d) at two consecutive time points in 1 of 8 aerobic studies.

 

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

Anaerobic degradation

Mineralisation after 100 days

 

0-31.9 % after 90-94 days [U-14C]-Phenyl-tefluthrin labelled

Non-extractable residues after 100 days

2.1-14.9 % after 90-94 d, [U-14C-aniline] labelled

Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)

Compound Ia (R119890) 0 - 24.7 %

Compound III (R153946) 0 - 18.3 %

 

Soil photolysis

Mineralisation after 30 d

non-extractable residues after 30 d

Soil photolysis is not relevant to the planned usage of tefluthrin as a pelleted seed dressing where normal agricultural practice in Northern Europe would be to drill seed into the field to a depth of below 2 cm and cover with soil

Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)

none

 

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

Laboratory studies

Parent

Aerobic conditions

Soil type (site)

X[1]

pH

t. oC / % MWHC

DT50 /DT90 (d) (report)

DT50 (d)

20 °C pF2/10kPa

St.

(r2)

Model, Kinetics; Method of calculation

18 acres , sandy loam

 

6.8

20 °C/40 % MWHC

48 / 160

48

-**

SFO

18 acres , sandy loam

 

6.8

20 °C/40 % MWHC

151*** / -*

151

-**

SFO

Frensham, loamy sand

 

5.3

20 °C/40 % MWHC

63 / -*

63

-**

SFO

18 acres , sandy loam

 

6.5

5 °C/40 % MWHC

134 /-*

41

-**

SFO

18 acres , sandy loam

 

6.5

20 °C/40 % MWHC

13 / 43

13

-**

SFO

18 acres , sandy loam

 

6.5

20 °C/40 % MWHC

20 / 67

20

-**

SFO

18 acres , sandy loam

 

6.5

20 °C/40 % MWHC

26 / 86

26

-**

SFO

18 acres , sandy loam

 

6.5

30 °C/40 % MWHC

17 / 58

37

-**

SFO

Geometric mean/median (DT50)

 

 

38.4 / 39

 

 

* The DT90 values are unreliable and are not quoted since time points after 90 % degradation, necessary to obtain reliable estimates, were not available

** r˛ not provided

*** This result for the granule treatment was atypical because of the relatively high rate of the granules applied to a laboratory soil where redistribution would be slow and sites for microbial degradation easily saturated (see B8.1)

 

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

Laboratory studies

Compound Ia

Aerobic conditions

Soil type (site)

X[2]

pH

t. oC / % MWHC

DT50 /DT90 (d) (report)

DT50 (d)

20°C pF2/10kPa

St.

(r2)

Model, Kinetics; Method of calculation

18 acres , sandy loam

 

6.8

20 °C/40 % MWHC

16 / 48*

16

-**

SFO

Geometric mean/median (DT50)

 

 

16

 

 

** r˛ not provided, estimation of DT90 by RMS based on DT50: DT90=DT50*3 = 16 * 3 = 48 d

 

 

Field studies

Parent

Aerobic conditions

Soil type

Location

X1

pH

 

Depth (cm)

DT50 (d)

 

DT90(d)

St.

(r2)

Method of calculation

silty loam

Buchen, Germany 1987

 

6.4

0 – 30

25/ 14

84/ 241

-**

SFO / FOMC

silty loam

Varendorf, Germany 1987

 

5.7

0 – 25

16/ 15

53/ 66

-**

SFO / FOMC

sandy loam

Kapellen, Germany 1987

 

7.8

0 – 30

13/ 9

45/ 86

-**

SFO / FOMC

<sandy loam

Ottersweier, Germany 1987

 

5.3

0 – 30

42/ 35

138/ 219

-**

SFO / FOMC

clay loam

Langenerling, Germany 1987

 

8.3

0 – 30

14/ 9

45/ 74

-**

SFO / FOMC

silty loam

Inzkofen, Germany 1987

 

7.2

0 – 30

9/ 8

31/ 41

-**

SFO / FOMC

sandy silt loam

Vicksburg, Mississippi 1986

 

6.4

0 – 30

26/26

88

-**

SFO / FOMC

sandy silt loam

Champaign, Illinois 1986

 

6.6

0 – 30

165/84

-*

-**

SFO / FOMC

sandy loam

Goldsboro, IL USA

 

5.8

0-15

45

135#

0.825

linear 1st order

sandy clay loam

Champaign, IL USA

 

7.6

0-15

88

264#

0.557

linear 1st order

silty loam

White Heath, IL USA

 

6.0

0-15

106

318#

0.974

linear 1st order

sandy loam

Goldsboro, IL USA

 

5.8

0-15

29

87#

0.869

linear 1st order

sandy clay loam

Champaign, IL USA

 

7.6

0-15

79

237#

0.842

linear 1st order

silty loam

White Heath, IL USA

 

6.0

0-15

100

300#

0.789

linear 1st order

Geometric mean/median (DT50, n=14)

38 / 36

-

 

SFO

Geometric mean/median (DT50, n=8)

18 / 15

-

 

FOMC

* = DT90 value not quoted since time points after 90 % degradation, necessary to obtain reliable estimates, were not available, estimation of DT90 by RMS based on DT50: DT90=DT50*3 = 165 * 3 = 495 d

# = not given in the report estimation of DT90 by RMS based on DT50: DT90=DT50*3

** r˛ not provided, as r˛ is not reported it is not clear whether SFO or FOMC is the preferred kinetic

 

 

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

no

Soil accumulation and plateau concentration ‡

no studies performed, not necessary

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Parent 

Soil Type

OC %

Soil pH

Kd

Koc

Kf

Kfoc

1/n

Sandy clay loam

1.6

6.3

1800

112500

1200*

75000

0.93

Sandy loam

0.7

6.2

762

109000

332*

46000

0.83

Sandy loam

0.9

6.6

895

99500

2052*

228000

1.16

Silt loam

0.4

5.2

1067

267000

14400*

3600000

1.5

Sandy loam

1.7

5.8

1140

68000

1810

108000

1.08

Sandy loam

0.3

4.8

492

170000

1010

348000

1.15

Silty clay loam

2.5

4.8

1320

52700

2250

102000

1.12

Clay loam

5.1

7.2

1230

24200

4380

85700

1.23

arithmetic mean for PELMO calculation                       Kfoc =

574088

1.125

PH dependence, Yes or No

no

*: calculated by RMS based on Kfoc and OC

 

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

Column leaching

 

eluation (mm): 393 mm

Time period (d): 48 h

Tree soils: Speyer 2.1, 2.2 and 2.3

tefluthrin was not detected in leachate

(LOQ < 0.54 µg/L).

Aged residues leaching

Aged for (d): 1 month

Time period (d): 6 weeks

Eluation (mm): 660 mm in 6 weeks

Two soils: Acres, Frenshem

Radioactivity was not detected in leachate

(LOD < 0.00016 µg/L).

residues in soil (LOD < 0.0016 µg/L):

tefluthrin: 72 to 74 %

Compound III 0.3 to 1.8 %

Compound IV: 0.4 to 0.6 %

Compound V: 0.5 to 1 %

Lysimeter/field leaching studies

None relevant to representative EU use pattern

 

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

Hydrolytic degradation of the active substance and metabolites > 10%

pH 5 - pH 7: hydrolytically stable at 20 °C,

pH 9: DT50 > 30 d

(incubation time 30 d)

pH 9: Compound Ia: 34.6 %, Compound II: 21.4 %

Photolytic degradation of active substance and metabolites above 10%

 

pH 7, intensity 260-370 W/m˛ at 25 °C (290 – 400 nm)

as: residue 60-63 % after 31 d (DT50: 11.2 d*)

metabolites > trans-tefluthrin (R156944) 21.2 – 37.2 %

Quantum yield of direct phototransformation in water at S > 290 nm

not relevant

Calculation of photolytic half life (ABIWAS)

not relevant

Readily biodegradable 
(yes/no)

not readily biodegradable

* transferred to natural summer condition 40° N, calculation performed by RMS

 

Degradation in water / sediment

Parent

Distribution: in sediment max of 91 % at day 3; in water max of 29 % at day 0

(aerobic conditions, 20 °C)

Water / sediment system

pH w

pH sed

t. oC

DT50-DT90 whole sys.

St.

(r2)

DT50-DT90

water

St.

(r2)

DT50- DT90

sed

St.

(r2)

Method of calculation

study 1 I

Kromme Rijn

8.2

7.3

20

146/-**

-**

-#

-

203/-**

-**

 

SFO

study 1 II

TNO Zuidpolder

8.8

7.4

20

60/-**

 

-**

-#

-

204/-**

-**

SFO

Study 2

Old Basing

14C-Cyclopropyl Label

7.6

7.6

20

58/190

-**

-#

-

57/189

-**

SFO /FOMC

Study 2

Old Basing

14C-Phenyl label

7.6

7.6

20

51/185

-**

-#

-

59/195

-**

SFO /FOMC

Study 2

Old Basing

14C-Cyclopropyl Label

7.6

7.6

5

-/-

-

-

-

-/-

-

supplementary study, no DT50 values calculated

Study 2 c

Old Basing

14C-Phenyl label

7.6

7.6

5

-/-

-

-

-

-/-

-

supplementary study, no DT50 values calculated

Study 2 b

Old Basing

14C-Cyclopropyl label anaerobic conditions

7.6

7.6

20

-/-

-

-

-

-/-

-

supplementary study, no DT50 values calculated

Study 2 c

Old Basing

14C-Phenyl label

anaerobic conditions

7.6

7.6

20

-/-

-

-

-

-/-

-

supplementary study, no DT50 values calculated

Study 2 b

Old Basing

14C-Cyclopropyl label

anaerobic conditions

7.6

7.6

5

-/-

-

-

-

-/-

-

supplementary study, no DT50 values calculated

Study 2 c

Old Basing

14C-Phenyl label

anaerobic conditions

7.6

7.6

5

-/-

-

-

-

-/-

-

supplementary study, no DT50 values calculated

DT50

Geometric mean/median

 

71/59

 

-#

 

109/131

 

 

Compound I a

max 22 % (water, day 84, study 1 II),

max 7 % (sediment, day 84, study 1 II)

2 sequential measures > 5 % in water and sediment

Water / sediment system

pH w

pH sed

t. oC

DT50-DT90 whole sys.

St.

(r2)

DT50-DT90

water

r2

DT50- DT90

sed

St.

(r2)

Method of calculation

Geometric mean/median

 

 

 

 

 

 

 

no calculation performed

Compound II

max 3 % (sediment, day 7, study 1 II),

max 3 % (water, day 7, study 1 II)

Water / sediment system

pH w

pH sed

t. oC

DT50-DT90 whole sys.

St.

(r2)

DT50-DT90

water

r2

DT50- DT90

sed

St.

(r2)

Method of calculation

Geometric mean/median

 

 

 

 

 

 

 

not relevant

Compound IV

max 7.0 % (water, day 14, study 2), max. 22.6 % (water at 5°, day 360 study 2)

2 sequential measures > 5 % in water at 20 °C

Water / sediment system

pH w

pH sed

t. oC

DT50-DT90 whole sys.

St.

(r2)

DT50-DT90

water

r2

DT50- DT90

sed

St.

(r2)

Method of calculation

Geometric mean/median

 

 

 

 

 

 

 

no calculation performed

Compound V

max 2.3 % (water, day 7, study 2)

max 6.6 % (sediment, day 30, study 2), max 7.9 % in water at 5 °C

Water / sediment system

pH w

pH sed

t. oC

DT50-DT90 whole sys.

St.

(r2)

DT50-DT90

water

r2

DT50- DT90

sed

St.

(r2)

Method of calculation

Geometric mean/median

 

 

 

 

 

 

 

not relevant as

no sequential measures > 5 %

 (* no numerical solution possible, ** not given,

# calculation of DT50 in water not possible)

 

PEC (ground water) (Annex IIIA, point 9.2.1)

Method of calculation and type of study (e.g. modelling, field leaching, lysimeter ):

Modelling using FOCUS PELMO

For FOCUS gw modelling, values used –

Modelling using FOCUS model(s), with appropriate FOCUS gw scenarios, according to FOCUS guidance.

Model(s) used: FOCUS PELMO 3.3.2:

 

Scenarios (list of names):

Chateaudun, Hamburg, Kremsmünster, Okehampton, Piacenza, Porto,  Sevilla, Thiva

 

Crop: maize

interception: 0 (granules)

Parent

DT50lab: 31.9 d (arr. mean, n=6)

(normalisation to 10kPa or pF2, 20 °C with Q10 of 2.2).

Kfoc: 105000 L/kg (median, n=8), 1/n = 0.86.

Application rate

Application rate: 233 g/ha g/ha.

No. of applications:1

Time of application (month or season): 1 April

 

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

Direct photolysis in air

not relevant (incorporated below 4 cm of soil)

Quantum yield of direct phototransformation

not relevant (incorporated below 4 cm of soil)

Photochemical oxidative degradation in air

AOP-calculations:

AOP version 1.91:

DT50 = 0.94 d (24hr day; 0.5 x 106 OH/cm3)

Volatilisation

not relevant (incorporated below 4 cm of soil)

Max. 15,5% from soil (30 °C, after 60 d, soil degradation study, surface application)

Metabolites

not applicable

 

Residues requiring further assessment

Environmental occurring metabolite requiring further assessment by other disciplines (toxicology and ecotoxicology).

(Metabolites with >10 % of as or >5 % of as in 2 sequential measures)

Soil:                                                                  

active substance

Compound Ia (R119890) was formed in amounts > 5 % at two consecutive time points in 1 of 8 aerobic studies.

 

Surface Water:

active substance

Compound Ia (R119890) was formed in water sediment system with max. amounts of 22 %.

Compound Ia (R119890) was formed in amounts > 5 % at two consecutive time points in sediment.

Compound IV (R54170) was formed in amounts > 5 % at two consecutive time points in water.

 

Groundwater: active substance

Air: not relevant

 

 

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

Soil

not available

Surface water

 

not available

Ground water

 

not available

Air

 

not available

 

Points pertinent to the classification and proposed labelling with regard to fate and behaviour data

R53 - Tefluthrin can be classified as “not readily biodegradable”:

 

Appendix 1 - Compound code(s) used in the List of Endpoints

 

Code/Trivial name

Chemical name

Structural formula

Compound Ia

(1RS)-cis-3-(Z-2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylic acid

Compound II

2,3,5,6-tetrafluoro-4-methylbenzylalcohol

Compound III

2,3,5,6-tetrafluoro-4-methylbenzoic acid

Compound IV

2,3,5,6-tetrafluoroterephthalic acid

 

Non relevant metabolites

In the DAR, all metabolites (compound Ia, II, III and IV) are considered as ecotoxicologically non-relevant and are not further addressed in the EU risk assessment. For the current assessment, they are also not assessed. This is also due to the fact that they either do not occur in quantities > 10 % in relevant tests (aerobic soil metabolism), or that the fate of the metabolites for the particular compartment (i.c. surface water and sediment) does not need to be assessed due to the proposed use (seed treatment). Compound Ia (soil metabolite reaching 5 % at two consecutive timepoints) is assessed for groundwater.

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

Article 2 of the Regulation elaborating the uniform principles for plant protection products (RUUBG) describes the authorisation criterion persistence. The Board for the authorization of pesticides in the Netherlands (Ctgb) has to evaluate persistence in compliance with the INS[3] method. The accompanying supplementary notes to the RUUBG refer to a new ‘decision tree’, which has been laid down in the RIVM[4] report 601506008/2005: ‘Persistence of plant protection products in soil; a proposal for risk assessment. According to the RUUBG, persistence has to be evaluated by the Ctgb on the basis of this decision tree.

However, this decision tree is currently still under development, which means that it cannot be put into practice immediately. The new procedure for the assessment of persistence of plant protection products for authorisation will be implemented in the near future.

 

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

 

If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS method. This method is the same as the method described in the TGD to set a predicted no-effect concentration (PNEC).

 

For the current application this means the following:

 

Tefluthrin

A number of laboratory SFO DT50 values are available for the active substance tefluthrin in the List of Endpoints with a geomean/median value of 38.4/39 days. However, in these mean/median values, also a value from a study conducted at 5 °C corrected to 20 °C was included. Such a large temperature correction is not considered acceptable. Leaving this value out, the geomean value becomes 38.0 days.

 

The mean DT50-value of the a.s. can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO2.

Hence, the standards for persistence are met.

 

In addition, a number of field data are provided showing a mean/median DT50 of 38/36 days (n=14, SFO but also ‘linear first order’ fits) or a mean/median DT50 of 18/15 days (best-fit FOMC, n=8). Part of these field studies is not considered representative for The Netherlands (USA trials). If only the EU (German) studies (n=6) are regarded, the geomean DT50 value would be 17.4 (SFO) or 13.0 (FOMC) days.

 

From the results it is shown that the mean field DT50 of a.s. tefluthrin is < 90 days. Therefore, the standards for persistence are met.

 

For the metabolite compound Ia (formed in one aerobic laboratory degradation study at amounts > 5 % at two consecutive time points, maximum occurrence of 7.1 %) a DT50-value of 16 days (n=1) is available. This is considered a very small database. However, since the metabolite is not detected in field dissipation studies nor leaching tests, is not major in soil (> 10 %) and is considered not relevant for ecotoxicology, this is considered sufficient. No further ecotoxicological assessment is deemed necessary on the basis of the information in the DAR.

 

Based on the above, the standards of persistence are met.

 

PECsoil

The concentration of the a.s. tefluthin in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil in the case of seed treatment is calculated assuming a radial distribution of the a.s. around the seed. 

 

The following input data are used for the calculation:


 

PEC soil:

 

Active substance:

Mean lab DT50 for degradation in soil:  38.4 days

 

Molecular weight: 481.7 g/mol

 

The PIEC (mg/kg) for a seed treatment is calculated as: application rate in kg/ha / (radial influence in m3/ha* soil density in kg/m3) *10E6, which corresponds to 0.0156/(61 m3/ha for beet seed * 1500)*10E6 = 0.17 mg/kg.

 

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

 

Table M.1 PECsoil calculations (5 cm)

Use

Substance

Rate

[kg a.s./ha]

Freq.

Fraction on soil

PIECsoil

5 cm*

[mg a.s./kg]

PECsoil

28 days, wet weight

[mg a.s./kg]

Beets

tefluthrin

0.0156

1

0

0.17

0.11

* based on the radial distribution calculation method.

 

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

 

6.1.2    Leaching to shallow groundwater

The leaching potential of the active substance and metabolite compound Ia is calculated in the first tier using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate (0.0156 kg/ha), the crop (sugar beets) and an interception value 0. Date of yearly application is 25th of May.

 

For metabolites all available data concerning substance properties are regarded. Metabolites are modelled as parent. The application rate is corrected for formation rate and molecular weight relative to the parent substance.

In the DAR it is stated that ‘in one laboratory study (out of 8) in which 660 g active substance/ha of tefluthrin was applied to a single soil, the metabolite Compound Ia was formed in amounts of 5.7 % (day 13) and 7.1 % (day 60) declining below 5 % thereafter. Using ModelManager v1.1 (ModelKinetix, UK), the calculated DT50 value for Compound Ia from this study was 16 days indicating that Compound Ia is of short persistence in aerobic soils. Given the low rates of application of tefluthrin as a seed treatment in sugar beet, the short persistence of this compound and its low level of formation it is highly unlikely to leach into groundwater.’

Ctgb is of the opinion that this approach is defendable. For confirmation, a PEARL 2.2.2 calculation has been performed based on the following worst-case default input values: an application rate of 6.3E-4 kg/ha, a lab DT50 value of 16 days, a worst-case Kom of 0 L/kg, and a vapour pressure and water solubility identical to that of the parent.

 

The following input data are used for the calculation:

 

PEARL:

 

Active substance tefluthrin:

Mean DT50 for degradation in soil (20°C):  38.4 days

Mean Kom (pH-independent): 83420 (based on a mean Koc of 141814 L/kg (leaving out the oulier value of 3600000 L/kg, since there were doubts about this value in the DAR) .

 

Saturated vapour pressure: 8.4E-3 Pa (20 °C)

Solubility in water: 0.016 mg/L (20 °C)

Molecular weight: 418.7 g/mol

 

Metabolite compound Ia:

Mean DT50 for degradation in soil (20°C):  16 days

Mean Kom (pH-independent): unknown (worst-case assumption 0 L/kg)

 

Saturated vapour pressure: see parent

Solubility in water: see parent (NB will be more water-soluble but no data)

Molecular weight: 242.5 g/mol

Correction factor: 0.07 (formation fraction metabolite) * 0.58 (relative molar ratio = M metabolite/M parent)

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for the a.s. tefluthin and the metabolite compound Ia following spring application, see Table M.2.

 

Table M.2 Leaching of a.s. tefluthrin and metabolite compound 1 as predicted by PEARL 2.2.2

Use

Substance

Rate substance

Frequency

Interval

Fraction

intercepted

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring *

[mg/L]

Beets

Tefluthrin

Compound Ia

0.0156

6.3E-4

1

-

0

< 0.001

0.002

*          incorporation at 5 cm since it concerns pelleted seeds

**         application on May 25th as this date is worst-case with respect to leaching potential. 

 

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

 

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

 

For compound Ia, the predicted leaching concentration –based on worst-case assumptions- is 0.002 µg/L, which is below the trigger of the standards and the Dutch specific trigger for groundwater protection areas.

 

Hence, the proposed application meets the standards for leaching.  

 

Lysimeter/field leaching studies

No relevant lysimeters are present in the DAR. They are not required.

 

Monitoring data

There are no data available regarding the presence of the substance tefluthrin (or compound Ia) in groundwater.

 

Conclusions

The proposed application of the product complies with the requirements concerning persistence and leaching in soil.

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water

Since the proposed application of Force is by means of a seed treatment, and the Dutch assessment only takes exposure via drift into account, no assessment for surface water has been performed.

 

Monitoring data

There are no data available regarding the presence of the substance tefluthrin in surface water (source Pesticide Atlas on Internet).

 

Drinking water criterion

As at the currently proposed application no exposure to surface water is expected based on the current methodology (drift module only), no exposure at drinking water abstraction points is expected.

The standards for surface water destined for the production of drinking water are met.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

tefluthrin

The vapour pressure is 8.4 E-3 Pa at 20°C. The Henry constant is 2 E2 Pa m3 mol-1 at 20°C. The half-life in air is 0.94 d (24hr day; 0.5 x 106 OH/cm3) based on AOP calculation.

 

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

 

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

See List of Endpoints.

 

6.5       Data requirements

None.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

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

 

 

7          Ecotoxicology

 

The DAR (RMS Germany) will be used as basis for the assessment, together with the Dutch comments on the DAR (added in italic to the List of Endpoints). No additional (formulation) data have been provided, since the proposed use and the formulation matches the intended use in the DAR. A former authorisation of Force in The Netherlands was withdrawn in 1999. Since now a DAR is available, the data and the risk assessments belonging to this earlier authorisation are not taken into account in the current assessment. It should be noted that currently a non-inclusion is proposed by RMS, partly due to data gaps concerning the environmental assessment.

List of Endpoints Ecotoxicology (August 2006)

 

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

Species

Test substance

Time scale

Endpoint

(mg/kg bw/d)

Endpoint

(mg/kg feed)

Birds

Passer domesticus

Tefluthrin as

Acute

LD50   267

Not relevant

 

Preparation

Acute

No data submitted – justification accepted

 

Metabolites

Acute

Anas platyrhynchus

Tefluthrin as

Short-term

LD50   > 1791)

LC50     2317

Colinus virginianus

Tefluthrin as

Long-term, reproduction

NOEL   ≥ 2.0

NOEC   ≥ 25

Mammals

Rat

Tefluthrin as

Acute

LD50   21.8

Not relevant

Rat

Preparation 20% CS

Acute

LD50   > 344 2)

Not relevant

Rat

Metabolite

Acute

No data submitted - not relevant

Rat

Tefluthrin as

Short-term, 90-day
mortality

NOEL 31.8

NOEC 350

Rat

Tefluthrin as

Long-term, 3-gen. reproduction study
reduced litter size, red. offspring bw

NOEL 4.7

NOEC  50

Rat

Metabolites

Long-term

No data submitted - not relevant

Additional higher tier studies

No data submitted – justification accepted

1) Daily dietary dose was calculated with 793 mg as/kg feed, the highest conc. without food avoidance and mortality. This represents a conservative LD50.

2) In common with other pyrethroid micro-encapsulated products, the CS micro-encapsulated formulation of tefluthrin is significantly less toxic than the active substance alone. Acute exposure will be to the encapsulated formulated product, rather than to the technical active substance, so the endpoint for the similar 20 % CS formulation will be used in the acute risk assessment.

 

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

(Test type)

Endpoint

Toxicity1

(mg/L)

Laboratory tests

Fish

Oncorhynchus mykiss

Tefluthrin

Acute, 96 h (static)

Mortality, EC50

0.00006 mm

Pimephales promelas

Tefluthrin

Chronic, 345 d (flow-through)

NOEC

0.00000397 mm

Oncorhynchus mykiss

Preparation
Tefluthrin 300 g/L CS

Acute 96 h (static)

Mortality, EC50

0.00033 as nom
0.0012 product nom

Oncorhynchus mykiss

Metabolite
Compound Ia
(PP890)

Acute 96 h (static)

Mortality, EC50

> 15.8 mm

Oncorhynchus mykiss

Metabolite Compound III (Tefluthrin 2,3,5,6-tetrafluoro-4-methyl-benzoic acid )4

Acute, 96 h (static)

Mortality, EC50

> 100 nom

Aquatic invertebrate

Daphnia magna

Tefluthrin

Acute 48 h (static)

Mortality, EC50

0.00007 mm

Daphnia magna

Tefluthrin

Acute 48 h (static)

Mortality, EC50

0.000064 mm

Daphnia magna

Preparation
Tefluthrin 300 g/L CS

Acute 48 h (static)

Mortality, EC50

0.0079 mm product
(0.0021 mm as)

Daphnia magna

Tefluthrin

Chronic 21 d (semi-static)

Reproduction, NOEC

0.00000792 mm

Daphnia magna

Metabolite
Compound Ia (PP890)

Acute 48 h (static)

Mortality, EC50

> 182 nom

Daphnia magna

Metabolite
Compound III

Acute 48 h (static)

Mortality, EC50

> 120 nom

Sediment dwelling organisms

Chironomus riparius

Tefluthrin

Chronic 28 d (static)

no data submitted,
not required

-

Algae

Pseudokirchneriella subcapitata

Tefluthrin

Chronic 72 hr (static)

Biomass: EbC50

Growth rate: ErC50

> 1.05 nom

> 1.05 nom

Pseudokirchneriella subcapitata

Preparation
Tefluthrin 200 g/L CS

Chronic 72 hr (static)

Biomass: EbC50

Growth rate: ErC50

82 product nom
(15 as)

100 product nom (18.3 as)

Pseudokirchneriella subcapitata

Metabolite

Chronic 72 hr (static)

no data submitted,
not required

-

Higher plant

Lemna gibba

Tefluthrin

7 d (semi-static)

no data submitted,
not required

-

Lemna gibba

Preparation

7 d (static)

no data submitted,
not required

-

Microcosm or mesocosm tests

Not required, not relevant

1 indicate whether based on nominal (nom = analytically confirmed) or mean measured concentrations (mm). In the case of preparations indicate whether endpoints are presented as units of preparation or as. No indication means concentration corresponds to test substance in column two.

 

Bioconcentration

 

Active substance

Metabolite1

Metabolite2

Metabolite3

logPow

6.4

 

 

 

Bioconcentration factor (BCF)1 whole fish‡

1400

Not relevant

Not relevant