Registration Dossier
Registration Dossier
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EC number: 200-456-2 | CAS number: 60-12-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Phenyl ethyl alcohol was not mutagenic in a reverse mutation assay performed with Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA both in the absence or presence of phenobarbitone/beta-naphthoflavone induced rat S-9 fraction (Harlan Laboratories Ltd, 2012a).
Testing was conducted using both plate incorporation and pre-incubation methods at five dose levels (up to 5000 ug/plate). It was also negative when tested with Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at 3 umol/plate (equivalent to 366 ug/plate) in the absence or presence of aroclor 1254 or methylcholanthrene induced rat S9 fraction (Florin et al., 1980).
An in vitro study for the detection of structural chromosomal aberrations in cultured mammalian cells was conducted on the test item Phenyl ethyl alcohol (Harlan Laboratories, 2012). Cultures of human lymphocytes were treated with the test item in duplicate and were evaluated for chromosome aberrations at three dose levels, together with vehicle and positive controls. The result of the test showed that the test item did not induce any statistically significant increases in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments. The test item Phenyl ethyl alcohol is not therefore considered to be clastogenic to human lymphocytes in vitro.
No increase in mutation at the TK +/- locus was recorded following incubation of Phenyl ethyl alcohol with L5178Y mouse lymphoma cells in the presence or absence of phenobarbitone/beta-naphathaflavone induced rat S9 fraction (Harlan Laboratories Ltd, 2012c). The study was conducted using dose levels up to 1220 ug/ml with two independent repeat experiments and differing exposure times (4 hr and/or 24 hr).
Short description of key information:
Phenylethyl alcohol is not mutagenic toward bacterial or mammalian systems, or clastogenic toward mammalian cell lines, when tested in the absence and/or presence of rat S-9 fraction in vitro.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available studies, there is no evidence of genetic toxicity and therefore Phenyl ethyl alcohol does not require classification according to Regulation (EC) No. 1272/2008.
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