Registration Dossier
Registration Dossier
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EC number: 310-080-1 | CAS number: 102242-49-9 The complex residue resulting from the vacuum distillation of C6-24 fatty alcohols which is derived from hydrogenation of C6-24 fatty acids methyl esters. It consists predominantly of satd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Three different in vitro genetic toxicity test were available. All three were considered reliable and consequently were used as key studies.
1. The mutagenic potential of the test substance was investigated in a study according to OECD 471 (Ames) using the five strains TA 1535, 1537, 1538, 98 and 100 with and without metabolic activation. Five test substance concentration from 8 to 5000 µg/plate and adequate positive controls were applied in agar. No enhanced mutation rate in the S9 treated or untreated cells was observed in the Ames test. Therefore, the test substance was considered not to be mutagenic.
2. The test substance was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster. The study was performed in two independent experiments with and without metabolic activation. Treatment duration was 4 or 24 hours. Precipitation was observed in for concentrations equal or higher than 35.0 µg/mL. Cytotoxic effects occurred only in concentrations showing very strong test item induced precipitation. In both experiments, all mutant frequencies remained well within the historical range of solvent controls. The induction factor did not exceed the threshold of three times the corresponding solvent control.
All controls were valid.
In this test according to OECD Guideline 476 under GLP, the test substance did not induce gene mutations at the HPRT locus in V79 cells (with and without metabolic activation). Therefore, it is considered to be non-mutagenic in this HPRT assay.
3.
The test substance was assessed for its potential to induce micronuclei in human lymphocytes in vitro in the absence and presence of metabolic activation by S9 mix acc. to OECD guideline 487 under GLP. Two independent experiments were performed, both with and without S9, with exposure periods of 4 or 20 hours. The chromosomes were prepared 40 hours after start of treatment with the test item. In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were scored for cytogenetic damage on coded slides.The highest treatment concentration in this study was chosen with regard to the solubility properties of the test item. While no cytotoxicity was observed, precipitation occured at 13.6 µg/mL or higher. In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying micronuclei was observed. All controls were valid.
In conclusion, it can be stated that under the experimental conditions reported, the test substance did not induce micronuclei in human lymphocytes in vitro,when tested up to precipitating concentrations.
Short description of key information:
genetic toxicity in vitro (Ames test): negative
genetic toxicity in vitro (HPRT): negative
genetic toxicity in vitro (micronucleus test): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on results of the key studies the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008) and also does not need to be classified according to DPD (67/548/EEC).
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