Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Experimental result on test item Condensation products of cyclopentanone and pentaldehyde, fractionation pitch (In Vitro):
Key study: Ames Test:
The reverse mutation was carried out according to OECD Guideline 471 (GLP study). The test substance is not mutagenic in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and, TA 100 and E. Coli WP2uvrA with and without metabolic activation. No cytotoxicity was observed in the absence and presence of S9 -mix up to the dose level of 5000 µg/plate.
Key study: Chromosome aberrations:
The chromosome aberration in cultured peripheral human lymphocytes was carried out according to OEDC Guideline 473 (GLP study). No chromosomal aberrations were induced in human lymphocytes tested with and without metabolic activation. No toxicity was observed up to and including the highest precipitating tested dose in the absence and presence of S9 -mix at 3, 24 and 48 hours exposure and 24 and 48 hours fixation time.
Key study: Mammalian cell gene mutation:
The mutagenic activity of test substance was carried out according to the OECD Guideline 476 (GLP study) showing no effects on the thymidine kinase locus in L5178Y mouse lymphoma cells. No toxicity was observed up to and including the highest test substance concentration of 100 µg/mL in the presence of S9 -mix and 50 and 60 µg/mL in the absence of S9 -mix.
Justification for selection of genetic toxicity endpoint
Three studies are available. All of them GLP compliant and of high quality (Klimisch 1).
All three in vitro studies were negative.
Short description of key information:
Key study: OECD Guideline 471 (Bacterial Reverse Mutation), 473 (Chromosome Aberration) and 476 (Mammalian Cell Gene Mutation). GLP studies. The test substance appeared to be not mutagenic in the Ames test and in a chromosome aberration study and it was negative in a Mouse Lymphoma assay with and without metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on all information available, Condensation products of cyclopentanone and pentaldehyde, fractionation pitch does not have to be classified for genotoxicity.
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