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EC number: 202-940-9 | CAS number: 101-41-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
3 genetic toxicity studies were performed according to OECD guidelines 471, 473 and 476 to determine the genetic toxicity potential of the test item. No genetic toxicity was observed in all three studies.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One Ames test with the test item is available. Two further read-across studies were used to address the in-vitro chromosome aberration and the in-vitro gene mutation (HPRT). This read across approach was applied using data of Ethyl Phenylacetate (CAS 101 -97 -3) as this substance was considered to show similar toxicological properties as compared to the test item. For further justification please refer to IUCLID section 13.
Ames test
The mutagenic effects of the test item were determined in a reverse mutation assay according to the principles of OECD Guideline No. 471 and EEC Directive 2000/32/EEC Method B. 13/14. Test strains were the Salmonelle typhimurium strains TA 97a, TA 98, TA 100, TA 102 and TA 1535 with (+) and without (-) the metabolic activation system S9 (from male Wistar rats) each. Positive and negative controls were included in each study. Duration of each study was 48 h. The test item was dissolved in DMSO and applied once at test initiation with the concentrations 0.05 - 0.16 - 0.5 - 1.6 - 5 mg/plate. The test substance showed no mutagenic effects with and without metabolic activation. Cytotoxic effects were observed only for TA97a in the highest concentration of 5 mg/plate.
Chromosome aberration test
The read across substance Ethylphenylacetate (CAS 101-97-3), dissolved in DMSO, was assessed for its potential to induce structural chromosomal aberrations in human lymphocytes in vitro in three independent experiments. In Experiment I in the absence and presence of S9 mix, in Experiment IIB in the absence of S9 mix and in Experiment IIA in the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In Experiment IIA in the absence of S9 mix no cytotoxicity was observed up to the highest evaluated concentration. Toxic effects, indicated by reduced mitotic indices were observed at higher concentrations. No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures. In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce structural chromosomal aberrations in human lymphocytes in vitro. Therefore, is considered to be non-clastogenic in this chromosome aberration test.
HPRT test
The read across study was performed to investigate the potential of Ethylphenylacetate (CAS 101-97-3) to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The treatment period was 4 hours with and without metabolic activation. The maximum test item concentration of the pre-experiment (1642 μg/mL) was equal to a molar concentration of about 10 mM. The concentration range of the main experiment was limited by phase separation of the test item and cytotoxicity. No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiment. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test item is considered to be non-mutagenic in this HPRT assay.
Conclusion: 3 genetic toxicity studies were performed according to OECD guidelines 471, 473 and 476 to determine the genetic toxicity potential of the test item. No genetic toxicity was observed in all three studies.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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