Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

The substance, an ester of 1,2,4 -benzenetricarboxylic acid with C8 linear side chains, has been tested both in a bacterial reverse mutation assays (Ames test) which showed the substance not to induce reverse mutation in Salmonella typhimurium or Escherichia coli and an in-vitro chromosome aberration test in cultured human lymphocytes which showed the substance not to induce chromosomal aberrations.

 

(Q)SAR results by Danish (Q)SAR database indicates that the substance is not predicted to exhibit mutagenic activity.

 

A structurally related substance, an ester of 1,2,4 -benzenetricarboxylic acid with mixed C8 and C10 linear side chains, has been examined in the bacterial reverse mutation test, chromosome aberration test and also in an

assay for the induction of 5‑trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells after in vitro treatment. The substance was negative in these tests.

REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriate in-vivo mutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations with the substance and two structurally similar substances were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.


Short description of key information:
Genetic toxicity in-vitro: Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non-classification is justified on the basis of negative findings in a number of in-vitro tests on the substance and a structurally similar substance for gene mutation / mutagenicity.