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.
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.053 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.53 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.005 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.219 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.022 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.013 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Conclusion on classification
Classification related key information
The listed data are based on test conducted with the 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).
Biodegradation in water (screening tests): readily biodegradable
2-Methylbutanol (CAS No. 137-32-6): 93% (TOC removal) after 28 days (OECD 310)
Ethanol (CAS No. 64-17-3): 97% (CO2 evolution) after 28 days (OECD 301B)
2-Methylpropanol (CAS No. 78-83-1): 70 – 80% (O2 consumption) after 28 days (OECD 301D)
Log Pow:
2-Methylbutanol (CAS No. 137-32-6): -1.26 (QSAR)
Ethanol (CAS No. 64-17-3): -0.30 to -0.35 (experimental literature data); 0.14 (QSAR)
3-Methylbutanol (CAS No. 123-51-3): -1.26 (QSAR)
2-Methylpropanol (CAS No. 78-83-1): -0.77 (QSAR)
Acute toxicity
- to fish:
2-Methylbutanol (CAS No. 137-32-6): LC50 (96 h) > 120 mg/L (nominal), Danio rerio (OECD 203)
Ethanol (CAS No. 64-17-3): LC50 (96 h) = 15.3 g/L (mean measured), Pimephales promelas (US EPA E03-05)
3-Methylbutanol (CAS No. 123-51-3) LC50 (96 h) = 305.13 mg/L (nominal) (QSAR)
2-Methypropanol (CAS No. 78-83-1) LC50 (96 h) = 693.96 mg/L (nominal) (QSAR)
- to invertebrates:
2-Methylbutanol (CAS No. 137-32-6): EC50 (48 h) > 173 mg/L (mean measured), Daphnia magna (OECD 202)
Ethanol (CAS No. 64-17-3): EC50 (48 h) = 5012 mg/L (nominal), Ceriodaphnia dubia (ASTM E729-80)
3-Methylbutanol (CAS No. 123-51-3) EC50 (48 h) = 154.20 mg/L (nominal) (QSAR)
2-Methypropanol (CAS No. 78-83-1) EC50 (48 h) = 326.14 mg/L (nominal) (QSAR)
- to algae:
2-Methylbutanol (CAS No. 137-32-6): ErC50 (72 h) > 353 mg/L (mean measured), Pseudokirchneriella subcapitata (OECD 201)
Ethanol (CAS No. 64-17-3): ErC50 (5 d) = 275 mg/L (nominal), Chlorella vulgaris (equivalent OECD 201)
3-Methylbutanol (CAS No. 123-51-3) EC50 (72 h) = 53.05 mg/L (nominal) (QSAR)
2-Methypropanol (CAS No. 78-83-1) EC50 (72 h) = 90.65 mg/L (nominal) (QSAR)
Chronic toxicity:
- to fish: Ethanol (CAS No. 64-17-3): ChV (NOEC) = 245 mg/L (nominal), (QSAR)
- to invertebrates: Ethanol (CAS No. 64-17-3): NOEC = 9.6 mg/L (nominal), Daphnia magna and Ceriodaphnia dubia (method according Mount and Norberg, 1984)
- to algae:
2-Methylbutanol (CAS No. 137-32-6): NOErC (72 h) = 29 mg/L (mean measured), Pseudokirchneriella subcapitata (OECD 201)
Ethanol (CAS No. 64-17-3): ErC10 (5 d) = 11.5 mg/L (nominal), Chlorella vulgaris (equivalent OECD 201)
Classification justification according to CLP
Based on the data above, Fusel oil is considered to be readily biodegradable and have low bioaccumulation potential. The acute aquatic toxicity L(E)C50 is > 1 mg/L for fish, invertebrates and algae. Valid chronic toxicity data are available for the constituent ethanol, with NOEC > 1 mg/L. Therefore, Fusel oil does not need to be classified according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).
Classification justification according to DSD
Based on the data above, Fusel oil is considered to have no potential for accumulation (log Pow < 3) and is rapidly degradable. The acute aquatic toxicity L(E)C50 is > 10 mg/L for all trophic levels. Therefore Fusel oil does not need to be classified according to the Directive 67/548/EEC.
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