Registration Dossier

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Toxicity testing of the substance in birds is waived, in accordance with Regulation (EC) No.1907/2006, Annex X, Column 2.  

Key value for chemical safety assessment

Additional information

In accordance with Regulation (EC) No.1907/2006, Annex X, Section 9.6.1, Column 2, studies on the effects of a substance upon birds should be conducted only if other data, including mammalian toxicity data, are inadequate for the evaluation secondary poisoning risks to predators following chronic exposure to a substance via the fish and earthworm food chains (Section R.7.10.14,Guidance on information requirements and chemical safety assessment,Chapter R.7C, Endpoint-specific guidance, May 2008). An acceptable database of repeat dose oral toxicity data is available for mammals (i.e., 28-d oral study in rodents with reproductive toxicity screening). In addition, evaluation of upper trophic level exposures (secondary poisoning) is not of concern. "Secondary poisoning" refers to the toxic effects in the higher members of a food chain that result from ingestion of organisms from lower trophic levels that contain accumulated substances (and/or related metabolites). To be evaluated for secondary poisoning, the chemical must have a log Kow≥ 3ora BCF ≥ 100;andno mitigating property such as biodegradability or hydrolysis (half-life less than 12 hours). The log Kowfor the substance is4.39. However, the substance has been shown to undergo rapid hydrolysis at environmentally relevant pH and temperature conditions (i.e., at pH 4, DT50= 61 minutes at 15 °C and DT50= 37 minutes at 25 °C; at pH 7, DT50 = 44 minutes at 15 °C and DT50 = 22 minutes at 25 °C; at pH 9, DT50 = 4.9 minutes at 15 °C and DT50 = 2.3 minutes at 25 °C). Each of these hydrolysis half-life values is substantially below the threshold half-life of 12 hours, below which “it can be assumed that the rate of hydrolysis is greater than that for uptake by exposed organisms” (Chapter R.7.c, “Endpoint-specific guidance”, Guidance on information requirements and chemical safety assessment, ECHA, May 2008, Section R.7.10.3.4, p. 24). Therefore, the substance may be waived with respect to the evaluation of secondary poisoning and the derivation of a PNECoral for wildlife exposures, including the food chain exposures of birds (Section R.10.8.1, Chapter R.10, Characterisation of dose[concentration]-response for environment, of Guidance on information requirements and chemical safety assessment, ECHA, May 2008).