Registration Dossier
Registration Dossier
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EC number: 413-390-6 | CAS number: 149144-85-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The Ames-test with and without metabolic activation did not induce an increase in the number of revertant colonies compared to the negative controls and was considered as non-mutagenic for the test substance Bis(C12 -C13)alkyl-2 -hydroxybutandioate. Also for the read-across substance DTDA the Ames-test was negative. For the read-across substance DEHA the Mouse Lymphoma Test and the Chromosome aberration test in Chinese Hamster Ovary cellls with metabolic activation were negative. The Chromosome aberration test without metabolic activation showed some evidence of mutagenicity.
The test substance Bis(C12-C13)alkyl-2-hydroxybutandioate did not cause damage to this mitotic system in the Micronuclues assay in mice.
The metabolite Malic acid was not mutagenic across a range of genotoxicity tests (International Journal of Toxicology, 1991).
Short description of key information:
For Bis(C12-C13)alkyl-2-hydroxybutanedioate, the in vitro test (Ames test, with and without metabolic activation) was negative.
Also for the read-across substance DTDA the Ames-test was negative. For the read-across substance DEHA the Mouse Lymphoma Test and the Chromosome aberration test in Chinese Hamster Ovary cellls with metabolic activation were negative. The Chromosome aberration test without metabolic activation showed some evidence of mutagenicity.
The test substance Bis(C12-C13)alkyl-2-hydroxybutandioate did not cause damage to this mitotic system in the Micronuclues assay in mice.
Therefore the substance is considered as not genotoxic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification for genetic toxicity is indicated according to the general classification and labeling requirements for dangerous substances and preparations (67/544 EEC) or the classification, labeling and packaging (CLP) regulation (EC 1272/2008).
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