Registration Dossier

Administrative data

Description of key information

Skin irritation, read-across data,  1 key study and 1 supporting study-non irritating for rabbits (similar to OECD TG 404)
Eye irritation, read-across data, 1 key study and 1 supporting study-non irritating for rabbits (similar to OECD TG 405)

Key value for chemical safety assessment

Additional information

No irritation data were found 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. 

 

Skin:The dermal irritation potential of the submission substance has been evaluated based on read-across data under occluded conditions. The results indicate negligible dermal irritation.

 

Eye:The ocular irritation potential of the submission substance has been evaluated based on read-across data performed in a manner similar or equivalent to currently established OECD guidelines. The results indicate negligible ocular irritation.

 

Respiratory:The respiratory tract irritation potential of the submission substance is not known, as no data are available for this endpoint.

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).

Justification for classification or non-classification

Based on assessment of the available read-across data for the submission substance, classification is not warranted as an eye or skin irritant 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.

There is no evidence of irritation to the respiratory tract warranting classification.