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.
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Fusel oil is based on the criteria set out in the "Guideline on information requirements and chemical safety assessment, Chapter R. 11: PBT Assessment" (ECHA 2012).
Persistence:
For three of the four the main constituents of Fusel oil, 2 -Methylbutanol (CAS No. 137-32-6), Ethanol (CAS No. 64-17-5) and 2-Methylpropanol (CAS No. 78-83-1) studies on "readily biodegradability" according to the OECD-methods were conducted resulting in 70 – 93% biodegradation of the test substances after 28 days. No biodegradation studies are available for 3 -Methylbutanol (CAS No. 123 -51 -3), but this constituent is structurally very similar to 2 -Methylbutanol and is thus expected to be readily biodegradable as well. Thus, the Fusel oil does not meet the screening criterion for persistency and it is not considered to be persistent (P) or very persistent (vP).
Bioaccumulation:
The four main constituents of Fusel oil, 2 -Methylbutanol (CAS No. 137-32-6), Ethanol (CAS No. 64-17-5), 3-Methylbutanol (CAS No. 123-51-3) and 2-Methylpropanol (CAS No. 78-83-1) have a log Kow of -1.26 – 0.14 (QSAR and experimental literature data). Thus, the test substance does not meet the screening criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity:
Testing of two of the four main constituents of Fusel oil, 2 -Methylbutanol (CAS No. 137-32-6) and Ethanol (CAS No. 64-17-5) of on algae according or equivalent to the OECD-Method 201 resulted in a NOErC of 29 mg/L (mean measured, 2-Methylbutanol,Pseudokirchneriella subcapitata) and an EC10 of 11.5 mg/L (nominal, Ethanol, Chlorella vulgaris). Long-term testing of Ethanol (CAS No. 64-17-5) on daphnids (Daphnia magna and Ceriodaphnia dubia) according to Mount and Norberg (1984) led to a NOEC of 9.6 mg/L. Moreover, Fusel oil is not classified for STOT RE (Cat 1 or 2), carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. Thus the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and Fusel oil is not considered to meet the T criterion.
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