Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial reverse mutation assay (Ames test) showed that read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, does not induce reverse mutations in Salmonella typhimurium or Escherichia coli.

 

Potential mutagenic activity has been examined by assaying for the induction of 5‑trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells after in vitro treatment. The read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, did not induce mutations in mouse lymphoma L5178Y cells.

Read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, was assayed for the ability to cause chromosomal damage in cultured human lymphocytes, followingin-vitrotreatment in the absence and presence of S9 metabolic activation. The substance did not induce chromosomal aberrations in human lymphocytes after in-vitro treatment.

 

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 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.


Justification for selection of genetic toxicity endpoint
There are 3 in vitro studies available for read-across substance,. The results of all 3 studies were negative therefore 1 study has not been selected.

Short description of key information:
There are 3 in vitro studies available for read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate. The results of all 3 studies were negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds. 

By read-across, the above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for genetic toxicity is therefore required.