Registration Dossier
Registration Dossier
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EC number: 232-395-2 | CAS number: 8013-75-0 A combination of amyl alcohols, primarily isoamyl alcohol and 2-methyl-1-butanol. Other alcohols, acids, esters and aldehydes may also be present.
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. Thus, in accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed.
Key value for chemical safety assessment
Additional information
No studies are available on the long-term toxicity of Fusel oil to fish. For one of the main constituents Ethanol (CAS No. 64-17-5) single dose limit tests from studies using Ethanol as vehicle are available, which are regarded as not reliable.
According to the “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance”, long-term testing on invertebrates and fish is required if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. In the case on Fusel oil, short-term studies showed low toxicity to fish, invertebrates and algae (EC/LC50 > 100 mg/L). Moreover, the long-term studies with Ethanol are available for aquatic invertebrates, with a NOEC > 1 mg/L. In addition, a validated QSAR for Ethanol is given, resulting in a prediction that fish are the least sensitive species for chronic toxicity.
Based on the available information and for concerns of animal welfare, chronic testing on fish is not justified.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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