Registration Dossier
Registration Dossier
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EC number: 203-835-0 | CAS number: 111-11-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
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 long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
No data evaluating the chronic toxicity of methyl octanoate (CAS No. 111-11-5) to fish species are available. According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. Based on the results of the acute L(E)C50 values available for methyl octanoate with species from three different trophic levels (fish, aquatic invertebrates and algae), fish is the species showing the least sensitivity (no toxicological effects observed up to the limit of water solubility). According to the Guidance on information requirements, Chapter R.7b (ECHA, 2008) if it can be proven through experimental data that fish is at least a factor of 10 less sensitive than aquatic invertebrates and algae, no further testing requirements are necessary for this endpoint. The acute test conducted on fish species showed no toxicological effects up to the limit of water solubility whereas the EC50 values for aquatic invertebrates and algae are 5.6 and 4.7 mg/L (respectively, QSAR calculations). A chronic test on aquatic invertebrates according to OECD 211 resulted in a NOEC of 1.8 mg/L (measured). Since based on the acute values, aquatic invertebrates are expected to show higher sensitivity compared to fish species (also observed in the rest of the substances of the SCAE Me category), additional long-term toxicity testing on fish is not deemed necessary.
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