Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 253-138-0 | CAS number: 36631-30-8
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
