Registration Dossier
Registration Dossier
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EC number: 629-780-6 | CAS number: 1234694-02-0
Toxicity to birds
Administrative data
Link to relevant study record(s)
Description of key information
Toxicity to predators via secondary poisoning is not expected for Fatty acids, C12-16 and C18 unsatd., methyl esters (CAS No. 1234694-02-0).
Key value for chemical safety assessment
Additional information
No avian toxicity data are available for Fatty acids, C12-16 and C18 unsatd., methyl esters (CAS No. 1234694-02-0). According to Regulation (EC) No. 1907/2006, Annex X, Column 2, 9.6.1, any need for testing for this endpoint should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. Fatty acids, C12-16 and C18 unsatd., methyl esters is a readily biodegradable substance with a low potential for bioaccumulation in biota and therefore, according to the Guidance on information requirements and chemical safety assessment, Chapter R.7C, secondary poisoning is unlikely to occur (ECHA, 2008). The results of the repeated dose oral tests performed on mammals (structurally related analogue substance, according to Regulation (EC) No. 1907/2006, Annex XI, 1.5, see section 7.5) showed no toxic effects after an exposure of 28 days (NOAEL of 1000 mg/kg bw/day (JECDB, 2000)). The test substance is not classified for repeated dose toxicity or reproductive toxicity and therefore it is not considered to cause toxic effects if accumulated via the food chain.
Based on the above information and considering animal welfare, avian toxicity testing is not deemed necessary for Fatty acids, C12-16 and C18 unsatd., methyl esters (CAS No. 1234694-02-0) and the PNEC oral is derived with mammalian toxicity data.
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