Registration Dossier
Registration Dossier
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EC number: 221-453-2 | CAS number: 3101-60-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The test substance, p-tert-butylphenyl-1-(2,3-epoxy) propyl ether induced significant, dose-related increases of genotoxicity without S9 liver metabolic activation as measured in the bacterial mutation test, Chinese hamster V79 cell SCE test and the CHO cell chromosome aberration assay. However, the test substance was negative in a second baterial mutation assay with and without liver S9 metabolic activation.
As per REACH Annex IX, Section 8.4 Colunm 2 an appropriate in vivo genotoxicity assay is proposed. Based upon positive findings for multiple endpoints of genotoxicity in vitro and Expert Judgement, the "In Vivo alkaline single-cell gel electrophoresis assay for DNA strand breaks (Comet assay)" in the rat is proposed. The in vivo "Comet" test is recommended in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance, Section R.7.7. Mutagenicity and carciongenicity, Table R.7.7 -4 "In vivo test methods, Somatic cells, page 381, and Section .7.7.6.3. "Testing strategy for mutagenicity, page 391 -392.
Furthermore, the "Comet" assay is a well recognized and internationally validated method for accessing DNA strand break/genotoxicity potential in vivo. A protocol for measuring the frequency of bone marrow micronuclei will be included in the study plan to evaluate chromosome damaging potential.
References:
A. Hartmann et. al. (2003) Recommendations for conducting thein vivo alkaline Comet assay. Mutagenesis 18: 45 -51.
B. Burlinson et. al. (2007) Fourth international workgroup on genotoxicity testing: results of the in vivo Comet assay workgroup. Mutation Res. Genetic Tox. Environ. Mutagen. 627: 31 -35.
K. S. Kumaravel et. al. (2009) Comet assay measurments: a perspective. Cell Biol. Toxicol. 25: 53 -64.
L. Forchhammer et. al. (2010) Variation in the measurment of DNA damage by comet assay measured by the ECVAG interlaboratory validation trial. Mutagenesis 25: 113 -123.
Justification for selection of genetic toxicity endpoint
The test substance, p-tert-butylphenyl-1-(2,3-epoxy) propyl ether induced bacterial gene-mutation and chromosome damage in vitro without liver derived metabolic activation.
Short description of key information:
The test substances was evaluated for genotoxicity potential in two independent O.E.C.D. test guideline 471 bacterial mutation assays, an O.E.C.D. test guideline 479 Chinese hamster V79 cell sister-chromatid-exchange (SCE) assay and a Chinese hamster ovary (CHO) cell chromosome aberration assay.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
No in vivo positive genotoxicity reults. Classification and Labelling as Mutagen currently not required.
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