Registration Dossier

Administrative data

Description of key information

Acute Toxicity Oral, read-across data, 1 key study and 2 supporting studies- LD50 >2000 mg/kg for rat (OECD TG 401, GLP)
Acute Toxicity Inhalation, read-across data, 1 key study- LC50 >2600 mg/m3 for rats (similar to OECD TG 403, GLP)
Acute Toxicity Dermal, read-across data, 1 key study and 1 supporting study-LD50 >1950 mg/kg in rabbits (similar to OECD TG 402, GLP)

Key value for chemical safety assessment

Additional information

No acute toxicity 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. 

 

Three studies were available on the acute oral toxicity of the Trimellitate Category members. In the key study, treatment by single-dose gavage with TOTM resulted in an LD50 >2000mg/kg. No deaths were reported in the study and no macroscopic abnormalities attributable to treatment were seen upon pathological examination.

 

For acute inhalation toxicity, one read-across study from TOTM was identified. No deaths were reported following a 4h exposure, resulting in an LC50 >2600mg/m3. 

 

For acute dermal toxicity, two studies were available for the read-across substance TOTM. In the key study, exposure for 24h to the abraded skin of rabbits resulted in no deaths and no notable pathology. The LD50 was reported to be >1970 mg/kg.

 

Based on these data the acute toxicity of the submission substances is expected to be low by all routes of exposure. 

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 70225-05-7 (see read-across justification in section 13 of IUCLID dossier for more information).

Justification for classification or non-classification

The submission substance has a low order of acute toxicity based on read-across data where the LD50 via ingestion is > 2000mg/kg; the LD50 via dermal exposure is >1950 mg/kg; and the LC50 via inhalation is >2600mg/m3. Based on these data, 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.