Registration Dossier
Registration Dossier
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EC number: 241-793-5 | CAS number: 17832-28-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
-in vitro bacteria gene mutation: negative
-in vitro mammalian gene mutation: negative
-in vitro chromosomal aberration: negative
Additional information
The Salmonella microsome assay (BASF 1991) was conducted according to the OECD Guideline 471 (acceptable restrictions: not tested in S. typhimurium TA102 or E. coli WP2uvrA, no GLP, no data about historical vehicle controls [but within literature values]).
The test substance was tested in the standard plate test and the pre-incubation test with and without metabolic activation (MA) in S. typhimurium TA98, TA100, TA1535 and TA1537 at dose levels of 20 -5000 µg/plate. No increase in the number of revertants was detected in any strain with and without MA. No bacteriotoxic effect was observed, however, the test substance was tested up to the recommended limit dose of 5 mg/plate (OECD TG471). Vehicle controls and positive controls were valid. The test substance was not mutagenic under the experimental conditions chosen.
4 -(vinyloxy)butan-1 -ol was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro (OECD 476; BASF, 2010) . Two independent experiments were carried out, both with and without the addition of liver S9 mix from induced rats. The highest dose tested was 1200 µg/ml (10 mM). The negative controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, ethyl methanesulfonate and methylcholanthrene, led to the expected increase in the frequencies of forward mutations. The test substance did not cause any biologically relevant increase in the mutant frequencies both with and without metabolic activation.
4 -(vinyloxy)butan-1 -ol was assessed for its potential to induce structural chromosomal aberrations (clastogenic activity) and/or changes in the number of chromosomes (aneugenic activity) in V79 cells in vitro both in the absence and the presence of a metabolizing system (OECD 473; BASF SE, 2010). The test substance did not exhibit any cytotoxicity up to the highest required concentration of 1 200 μg/mL (approx. 10 mM). The negative controls gave frequencies of aberrations within the range expected for the V79 cell line. Both of the positive control substances, ethyl methanesulfonate and cyclophosphamide, led to the expected increase in the number of cells containing structural chromosomal aberrations. The test substance did not cause any biologically relevant increase in the number of structurally aberrant metaphases at both sampling times neither with nor without S9 mix in three experiments performed independently of each other. No relevant increase in the frequency of cells containing numerical chromosome aberrations was demonstrated either. Thus, 4 -(vinyloxy)butan-1 -ol is considered not to have a chromosome-damaging (clastogenic) effect under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.
Justification for classification or non-classification
Classification for genetic toxicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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