Fenamiphos

Endpoint summary

Description of key information

For the risk assessment according to Regulation (EC) No 1907/2006 (REACH), a NOEC of 0.313 mg a.i./kg soil dw is used.

Additional information

The substance is registered for the tonnage band of 10-100 tonnes/year. Therefore, only data requirements according to Annex VII to VIII of Regulation (EC) No 1907/2006 (REACH) apply. Hence, data on terrestrial toxicity are not required. However, experimental data on bee, non-target arthropods other than bees, non-target soil meso- and macrofauna, terrestrial plants as well as soil microorganisms were submitted with the original Fenamiphos plant protection product dossier (IIA, Point 8.3.2 and 8.5 Annex III point 10.5.1) and evaluated in the Draft Assessment Report (DAR) (Vol. 3, Annex B, Point 9.5 and 9.9, November 2003). Results from the studies were included in the EFSA conclusion (EFSA Scientific Report (2006) 62, 1-81). The available key information is summarised below and considered for the Risk Assessment according to REACH.

 

Effects on bees

This point was covered in the original plant protection product dossier (IIA, Point 8.3.2 and 8.5 Annex III point 10.5.1) and evaluated in the Draft Assessment Report (DAR) (Vol. 3, Annex B, Point 9.5 and 9.9, November 2003). Results from the studies were included in the EFSA conclusion (EFSA Scientific Report (2006) 62, 1-81).

Available key information is summarized in Table 1.

 

Table 1: Ecotoxicological endpoints for bees

Organism	Study type and duration	Test substance	Origin	Ecotoxicological endpoint/conclusion*
Honey bee	Acute toxicity, 48 h	a.s.	IIA 8.3.1.1/01	LD50 contact: [µg a.s./bee]: LD50 oral: [µg a.s./bee]:	0.28 0.45
Bumblebee	Acute toxicity, 48 h	a.s.	IIA 8.3.1.1/02	LD50 contact: [µg a.s./bee]:	1.59
Bumblebee	Tunnel tests in greenhouses. 28 days exposure.	240 CS 4.8 & 10 kg a.s./ha	IIIA 10.4.5/01	No effects on mortality, pollination, consumption of sugar solution and growth of bumblebee colonies.

*   From the EFSA Scientific Report list of endpoints or Draft Assessment Report (2003).  Volume 3, Annex B9.4.

 

Effects on non-target arthropods other than bees

This point was covered in the original Fenamiphos plant protection product dossier (IIA, Point 8.3.2 and 8.5 Annex III point 10.5.1) and evaluated in the Draft Assessment Report (DAR) (Vol. 3, Annex B, Point 9.5 and 9.9, November 2003). Results from the studies were included in the EFSA conclusion (EFSA Scientific Report (2006) 62, 1-81).

The risk of exposure to non-target arthropods is negligible as the product will only be applied by drip irrigation in greenhouses and residue levels in crops are expected to be very low due to the rapid metabolism of the active substance.

The toxicity profile of the test substance and its major metabolites to non-target arthropods other than bees is summarised in Tables CA 8.3.2-1 and CA 8.3.2-2. Studies were conducted on Aphidius rhopalosiphi, Typhlodromus pyri, Chrysoperla carnea and Poecilus cupreus. A further study on the soil dwelling Poecilus cupreus after application of Nemacur 240 CS by drip irrigation was also carried out (Gray 2005b, Annex III, Point 10.5.1)). Toxicity studies on soil-dwelling Folsomia candida and Hypoaspis aculifer species are available..

Table 2:  Ecotoxicological endpoints on non-target arthropods other than bees

Organisms	Duration / Exposure	Test Subst. / Mode of application	Appl. Rate (g a.s./ha)	Origin	Endpoint(s)*
Parasitoids
Aphidius rhopalosiphi	Spray deposits on glass plates; 48 h exposure	240 CS / spray appl.	0.023 – 0.928	IIA 8.3.2/01	Mort., LR50 [g a.s./ha]	0.175
Aphidius rhopalosiphi	Spray deposits on Tomato plants 48 h exposure	240 CS / spray appl.	1 - 33.6	IIA 8.3.2/02	Mort., LR50 [g a.s./ha] Fec., NOEC [g a.s./ha]	14.1 14.2
Predatory mites
Typhlodromus pyri	Spray deposits on glass plates; Mort. 7 d Fec. (eggs / female) at 14 d	240 CS / spray appl.	0.25 - 4	IIA 8.3.2/03	Mort., LR50 [g a.s./ha] Fec., NOEC [g a.s./ha]	1.7 ≥ 1
Typhlodromus pyri	Spray deposits on glass plates; Mort. 7 d Fec. (eggs / female) at 14 d	240 CS / spray appl.	1 - 33.6	IIA 8.3.2/04	Mort., LR50 [g a.s./ha] Fec., NOEC [g a.s./ha]	13.8 14.2
Foliage dwelling predators
Chrysoperla carnea	Spray deposits on tomato leaves; 7 d	240 CS / spray appl.	5.4 - 108	IIA 8.3.2 05	Mort., LR50 [g a.s./ha] Rep., NOEC [g a.s./ha]	33.3 > 1.6
Ground dwelling predators
Poecilus cupreus	Treated LUFA 2.1 soil; Mort. rate; number of cons. pupae per beetle; Test duration: 22 d	240 CS / spray appl.	52 - 516	IIA 8.3.2/07	Mort., LR50 [g a.s./ha] Feed rate., NOEC  [g a.s./ha]	219   163
Poecilus cupreus	Sandy loam treated soil Mort. and predation 21 d exposure	240 CS / drip irrigation treatment	10	IIIA 10.5.2/01 below	No effects on survival, behaviour and predation rate.
Folsomia candida (collembola)	Repro. 28 d	240 CS / incorporation	0.313, 0.625, 1.25, 2.50, 5 and 10 mg a.s./kg soil	II A 8.6./03	LC50 (mort.): [mg a.s./kg d.wt.soil] NOEC (mort.): [mg a.s./kg d.wt.soil] NOEC(repro.): [mg a.s./kg d.wt.soil]	4.07   1.25   0.313
Hypoaspis aculeifer (soil mite)	Mort. 14 d	240 CS / incorporation	0.0013, 0.013, 0.133, 1.33 mg a.s./kg soil	III A 10.6.2/06	LC50 (mort.): [mg a.s./ha] d.wt.soil NOEC (mort.) [mg a.s./kg d.wt.soil] the highest concentration tested.	> 1.33   > 1.33
Folsomia candida (collembola)	Repro.56 d	240 CS / drip irrigation treatment	10kg a.s./ha 117 DAT soil residue FEN:0.12 mg/kg + FOX 0.17mg/kg + FON 0.02 mg/kg	III A 10.5.2/02 below	adult mort. [%] in treated greenhouse soil untreated greenhouse soil OECD soil	100   100   0

*   From the EFSA Scientific Report list of endpoints or Draft Assessment Report (2003). Volume 3, Annex B9.5 and 9.7.

 

 

Effects on Non-Target Soil Meso- and Macrofauna

This point was covered in the original plant protection product dossier (IIA, Point 8.3.2 and 8.5 Annex III point 10.5.1) and evaluated in the Draft Assessment Report (DAR) (Vol. 3, Annex B, Point 9.5 and 9.9, November 2003). Results from the studies were included in the EFSA conclusion (EFSA Scientific Report (2006) 62, 1-81).

Table 3 summarises the ecotoxicological endpoints for effects of the test substance on earthworms.

 

Table 3: Ecotoxicological endpoints for effects on earthworms

Organisms	Study type / Duration	Test Substance (Appl.-rate)	Endpoint*
Eisenia fetida	Acute, 14-d	a.s.	LC50: 888 mg as/kg d.wt.soil (10% OM) equivalent to 444 mg as/kg d.wt.soil for a soil with 5 % OM content.
Eisenia fetida	Acute, 14-d	240 CS	LC50: > 238mg as/kg d.wt.soil (10% OM) equivalent to > 119 mg as/kg d.wt.soil for a soil with 5 % OM content.
Eisenia fetida	Reproduction 56-d	400 EC 6, 10 & 40 kg as/ha	No adult mortality NOEC adult body weight < 6 kg a.s./ha NOEC reproduction < 6 kg a.s./ha
Eisenia fetida	Reproduction 56-d	240 CS (10 kg a.s./ha, aged residues)^2 a.s. (0.12 mg/kg) + sulfoxide (0.17 mg/kg) + sulfone (0.02 mg/kg) at same concentrations as measured in soil used in the above test^3	No adult mortality High loss of body weight and no reproduction in both treated and control soil sampled from a greenhouse Using standard OECD earthworm soil. No adult mortality. No influence on reproduction (number of juveniles). NOEC 0.31 mg/kg d.wt.soil TTR.
Earthworm Fauna	1-y	400 EC (10 and 40 kg as/ha)	Full recovery (number and biomass of earthworms) within a year at 10 kg a.s./ha not a 40 kg a.s./ha.

*   From the EFSA Scientific Report list of endpoints or Draft Assessment Report (2003). Volume 3, Annex B9.6.

²      Soil samples taken from greenhouse study with bumble bees after tomato harvest.

³      Concentrations of test substances corresponding to measured values in soil samples taken from greenhouse study with bumble bees after tomato harvest (Lechelt-Kunze 2002, Annex III, Point 10.6.1.2/02).

 

Effects on soil microorganisms

This point was covered in the original plant protection product dossier (IIA, Point 8.3.2 and 8.5 Annex III point 10.5.1) and evaluated in the Draft Assessment Report (DAR) (Vol. 3, Annex B, Point 9.5 and 9.9, November 2003). Results from the studies were included in the EFSA conclusion (EFSA Scientific Report (2006) 62, 1-81).

Table 4: Ecotoxicological endpoints for effects of the test substance and its major soil metabolites on nitrogen transformation

Test substance	Endpoint
fenamiphos	>25% after 56 days at 13.3 and 133 mg/kg
fenamiphos-sulfoxide	<25% after 56 days at 70 mg/kg
fenamiphos-sulfone	<25% after 56 days at 74 mg/kg
fenamiphos-sulfoxide-phenol	<25% after 42 days at 37 mg/kg

 

Effects on terrestrial plants

In a herbicidal screening test a total of 11 mono- and dicotyledonous plant species were tested under controlled greenhouse conditions in natural soil. 21 d after spray treatment of the potted seeds, phytotoxic effects were evaluated.

All tested plants species showed no phytotoxic effects (0 % = no visual damage, normal growth) up to the highest application rate of 15000 g a.i./ha, corresponding to 20 mg a.i./kg soil dw.

 

Conclusion

A broad range of reliable study information on terrestrial toxicity of the test substance is available. The most critical effect value is considered as starting point for the derivation of the PNEC soil. The 28-d NOEC for reproduction to Folsomia candida was 0.313 mg a.i./kg soil dw and was chosen as the most reliable key value for the risk assessment.

 

References:

Balluff, M. (2002). Evaluation of the side-effects on bumble-bees (Bombus terrestris L.) of drip irrigation treatments of Nemacur 240 CS to tomato plants in greenhouse compartments. GAB Biotechnologie GmbH, report no.: 20013003/S1-BFBt.

 

Bielza, P. et al. (2000). Effects of Confidor 20 LS and Nemacur CS on bumblebees pollinating greenhouse tomatoes.

 

Annual meeting, Pesticides and Beneficial Organisms; 2000; Castello de la Plana, Spain. IOBC WPRS BULLETIN; 24, 4; 83-88. report no.: Not applicable (conference paper).

 

FOCUS (1997). Soil persistence models and EU registration. The final report of the work of the Soil Modelling Work group of FOCUS (FOrum for the Co-ordination of pesticide fate models and their Use), 29.2.97.

 

Vinall, S. (2001). A laboratory test to determine the effects of FENAMIPHOS CS 240 on the parasitic wasp, Aphidius rhopalosiphi. Mambo-Tox Ltd., Southampton, U.K. Bayer AG, report no.: BAY-01-2.

 

Schuld, M.  (2000). FENAMIPHOS CS 240: Toxicity to the aphid parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae) in an extended laboratory test. GAB Biotechnologie GmbH, Niefern-Oeschelbronn, Germany Bayer AG, report no.: 99472/02-NEAP.

 

Stratum, P. van  (2002). A laboratory dose-response study to evaluate the effects of FENAMIPHOS CS 240 on survival and reproduction of the predaceous mite Typhlodromus pyri Scheuten (Acari: Phytoseiidae). MITOX Stichting Bevordering Duurzame Plaagbestrijding, Amsterdam, Netherlands; Bayer AG, report no.: B084TPL.

 

Adelberger, I. (2000). FENAMIPHOS CS 240: Toxicity to the predatory mite, Typhlodromus pyri Scheuten (Acari, Phytoseiidae) using an extended laboratory test. GAB Biotechnologie GmbH, Niefern-Oeschelbronn, Germany Bayer; AG, report no.: 99472/02-NETp.

 

Kemmeter, F. (2000). FENAMIPHOS CS 240: Determination of the LR50 (dose response) with the green lacewing, Chrysoperla carnea steph. (Neuroptera, Chrysopidae) using an extended laboratory test. GAB Biotechnologie GmbH, Niefern-Oeschelbronn, Germany; Bayer AG, report no.: 99472/02-NECC.

 

Neumann, P. (2001). Acute effects of a spray application of FENAMIPHOS CS 240 on carabid beetles (Poecilus cupreus) under extended laboratory test conditions. Bayer AG, report no.: NNP/PC017.

 

Gray, J.  (2005). Nemacur CS 240: Evaluation of the effects on the carabid beetle Poecilus cupreus in an extended laboratory study (drip irrigation). Huntingdon Life Sciences, report no.: IRV102/052088.

 

Heimbach, F.  (1996). Acute toxicity of Nemacur CS 240 to earthworms. Bayer AG, report no.: HBF/RG 228.

 

Heimbach, F.  (1994). Influence of Nemacur EC 400 on the reproduction of earthworms (Eisenia fetida).  Bayer AG, Report no.: HBF/RG 201.

 

Lechelt-Kunze, C.  (2002). Influence of fenamiphos, fenamiphos sulfoxide, and fenamiphos sulfone on the reproduction of earthworms (Eisenia fetida). Bayer AG, report no.: LKC/Rg 34/01.

 

Balluff, M.  (2001). Sampling of soil containing aged residues after drip irrigation treatment of Nemacur 240 CS to tomato plants in greenhouse compartments. GAB Biotechnologie GmbH, Niefern-Oeschelbronn, Germany;  Bayer AG,  report no.: 20013003/S1-FS.

 

Anspach, T.  (2001). Determination of the residues of fenamiphos and its metabolites fenamiphos sulfoxide and fenamiphos sulfone in soil specimens. Dr. Specht & Partner, Chemische Laboratorien GmbH, Hamburg, Germany; Bayer AG, report no.: Az.G01-0115.

 

Heimbach, F.  (1986). Effect of Nemacur 400 EC on the earthworm fauna of a grassland area. Bayer AG, report no.: HBF/RGF 8.

 

Friedrich, S.  (2001). Toxicity of Fenamiphos CS 240 on the reproduction of the collembola Folsomia candida. BioChem GmbH, Gerichshain, Germany; Bayer AG,  report no.: 011048043.

 

Jacobs, G.  (2002). SRA 3886 CS 240: Effects on survival of the predacious mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae) in standard soil. MITOX Stichting Bevordering Duurzame Plaagbestrijding, Amsterdam, The Netherlands; Bayer AG, report no.: B090HAE.

 

Carter, J.N. (2007). Nemacur CS 240 (fenamiphos). Effects on soil non target micro-organisms, nitrogen transformation. Huntingdon Life Sciences, Report no.: IRV0154/073726.

 

Meisner, P.  (2001). Herbicidal screening data for fenamiphos CS 240. Bayer AG, Report no.: MPE NTP 19/01.