Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetox studies were not located for the submission substance (CASRN 70225-05-7). However, data from the chemical category Trimellitates are available and was used as read-across in this hazard assessment. 

 

The submission substance is unlikely to be mutagenic based on read-across data.  In bacterial tests, the analogues substance TOTM was not mutagenic inSalmonellastrains tested in the presence or absence of metabolic activation (Ministry of Health & Welfare, Japan 1996).  Similarly, TOTM was not mutagenic inE coli(Ministry of Health & Welfare, Japan 1996) nor in anin vitromammalian cell mutagenicity test (Chemical Manufacturers Association, 1985). TOTM was not clastogenic in anin vitromammalian chromosome aberration test ((Ministry of Health & Welfare,1996).  All studies were conducted in a manner similar or equivalent to currently established OECD guidelines. Based on these data, this substance is considered to be non-genotoxic and classification is not warranted.

Justification for Read-Across

The Trimellitate Category-as defined in the US Environmental Protection Agency’s (EPA) High Production Volume (HPV) Challenge Program and the Organization for Economic Cooperation and Development’s (OECD) Screening Initial Data Set (SIDS)-, includes four chemicals containing individual trimellitate triesters or mixed trimellitate esters, which are defined as esters of 1,2,4,-benzenetricarboxylic acids that have branched or branched and linear alkyl groups. The members are: 1,2,4-benzenetricarboxylic acid, tris (2-ethylhexyl) ester (CASRN 3319-31-1 [TOTM]); 1.2.4-benzenetricarboxylic acid, triisooctyl ester (CASRN 27251-75-8 [TIOTM]); 1,2,4-benzenetricarboxylic acid, triisononyl ester (CASRN 53894-238 [TINTM]); and 1,2,4-benzenetricarboxylic acid, decyl octyl ester (CASRN 67989-23-5 [DOTM]).  The Trimellitate Category was formed on the principle that substances of similar structure have similar toxicological properties and the premise that a narrow range of ester carbon numbers will produce trends in physicochemical, environmental and toxicological properties.

 

The submission substance (CASRN 70225-05-7) fits the Trimellitate Category definition of an ester of 1,2,4-benzenetricarboxylic acid with branched and linear alkyl groups, with the distinction of having side chains of slightly longer length (C10, and C13). Because of the similarity in structure and physicochemical properties, it is reasonable to rely on theavailable data on the HPV Trimellitate substances to characterize the human health effects of CSRN 70255-05-7 (see read-across justification in section 13 of IUCLID dossier for more information).


Short description of key information:
In vitro gene mutation in bacteria, 1 key study and 1 supporting study, read-across-Negative (equivalent or similar to OECD TG 471)
In vitro, gene mutation mammalian, 1 key study, read-across-Negative (equivalent or similar to OECD TG 476)
In vitro chromosome abberation test, 1 key study, read-across-negative (equivalent or similar to OECD 473)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All in vitro genetic toxicity studies (i.e. gene mutation in bacteria, cytogenicity in mammalian cells, and gene mutation in mammalian cells) and an in vivo dominant lethal test for a structural analog showed negative results. Based on these results the submission substance is unlikely to be mutagenic and does not meet the criteria for classification as a genotoxin or a clastogen under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.