Registration Dossier
Registration Dossier
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EC number: 203-113-5 | CAS number: 103-45-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Phenylethyl acetate was investigated for the potential to induce reverse mutations in bacterial tester strains in the Ames test. No positive results were obtained in plate incorporation or pre-incubation assays with or without the use of metabolic activation.
The read-across substance benzyl acetate was considered to be mutagenic in the presence of metabolic activation in both the mouse and human lymphoma assays. Benzyl acetate showed a marginal induction of structural aberrations, predominantly chromatid exchanges but only at the highest dose in 24 hour continuous treatment without S9 mix. Because there was no structural aberration induction with any other treatment and the dose range used, it was still considered to be negative.
Benzyl acetate was investigated for its ability to unscheduled DNA synthesis in the hepatocytes of Fischer-344 rats following in vivo treatment. Rats received a single dose of the test substance dissolved or suspended in corn oil administered by oral gavage at dose levels of 5, 200 and 1000 mg/kg bw. The responses were examined at the 2 and 12 hour timepoints. Administration of benzyl acetate did not result in any increase in the numbers of net grains or the proportion of cells in repair.
Justification for selection of genetic toxicity endpoint
Higher tier study reporting a negative response
Short description of key information:
An Ames test is available for phenyl ethyl acetate. Studies of chromosomal aberration in vitro, mammalian cell mutation in vitro and UDS in vivo are available for the read-across substance benzyl acetate
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification is proposed for genetic toxicity. A positive result obtained in vitro with the read-across substance benzyl acetate was not replicated in a study in vivo. Other studies in vitro with phenyl ethyl acetate and benzyl acetate do not indicate a genotoxic hazard.
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