Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

All three in vitro studies were GLP compliant and of high quality (Klimisch score:1) and were clearly negative. The results are acceptable for the human health risk assessment.


Justification for selection of genetic toxicity endpoint
All three studies were clearly negative so no key study was selected.

Short description of key information:
Gene mutation (Bacterial Reverse Mutation Assay/Ames test): the substance tridecanedioic acid (CAS No. 505-52-2) did not induce mutagenicity using S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 102 in the presence or absence of Aroclor 1254 –induced rat liver S9 metabolic activation (OECD 471, GLP);

Chromosome aberration (in vitro mammalian cell micronucleus test): the substance tridecanedioic acid (CAS No. 505-52-2) does not induce an increase in micronucleus frequencies in Chinese hamster ovary (CHO-K1) cells in the presence or absence of Aroclor 1254 –induced rat liver S9 metabolic activation (OECD 487, GLP);

Gene mutation (in vitro mammalian cell gene mutation): the substance tridecanedioic acid (CAS No. 505-52-2) does not induce gene mutations in mouse lymphoma L5178Y cells in the presence or absence of Aroclor 1254 induced rat liver S9 metabolic activation (OECD 476, GLP).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information in the dossier, the substance tridecanedioic acid (CAS No. 505-52-2)

does not need to be classified for germ cell mutagenicity when the criteria outlined in Annex I of 1272/2008/EC are applied.