Registration Dossier
Registration Dossier
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EC number: 629-776-4 | CAS number: 308065-15-8
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil microorganisms
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the toxicity to soil microorganisms.
Key value for chemical safety assessment
Additional information
No experimental data evaluating the toxicity of Fatty acids, C12-14 (even numbered), methyl esters (CAS No. 308065-15-8) to soil microorganisms are available.
The test substance is characterized by a log Pow > 5 and log Koc > 3, indicating high potential for adsorption to soil particles. Tests with soil-dwelling organisms that feed on soil particles are therefore most relevant for the evaluation of soil toxicity ofFatty acids, C12-14 (even numbered), methyl esters. Soil invertebrates toxicity data from a suitable read-across substance (methyl laurate (CAS No. 111-82-0) in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5) are available. In this test performed according to OECD 222, no effects on survival, reproduction or growth of Eisenia fetida were reported, leading to a NOEC ≥ 1000 mg/kg dw (Winkelmann (2013)).
According to Chapter R7.b of the Guidance on information requirements and chemical safety assessment (ECHA, 2008), a test on soil microbial activity will be additionally necessary for a valid PNEC derivation only if inhibition of sewage sludge microbial activity has occurred. The test performed with methyl laurate (a suitable read-across substance) on aquatic microorganisms showed no inhibitory effects on activated sludge microorganisms activity (NOEC (3 h) ≥ 1000 mg/L (nominal) (Fiebig, 2013). Therefore, under the current exposure conditions, Fatty acids, C12-14 (even numbered), methyl esters does not pose a risk to soil organisms and further testing is not deemed necessary according to Regulation (EC) No. 1907/2006, Annex XI, section 3.
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