Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation data 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 sensitisation potential of the read-across substance TOTM was assessed in a manner similar or equivalent to currently established OECD guidelines. Sensitising properties were not observed in the treated group above that observed in the naïve control group following challenge. Based on these data, the submission substance is not considered to be a skin sensitizer.

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).


Migrated from Short description of key information:
skin sensitisation, read-across data, 1 key study and 1 supporting study-negative for guinea pigs (similar to OECD guideline 406)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No specific respiratory sensitisation tests have been conducted in animals. There is no evidence of respiratory sensitisation from existing animal study data.


Migrated from Short description of key information:
There are no specific studies available.

Justification for classification or non-classification

Based on assessment of two read-across skin sensitisation studies, the submission substance is not expected to be a sensitiser and therefore classification is not warranted 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.