Registration Dossier

Administrative data

Description of key information

The acute toxicity of 1,2,4 -benzenetricarboxylic acid, mixed dodecyl and octyl triesters towards rats was not specifically determined. The structural related substance 1,2,4 -benzenetricarboxylic acid, mixed decyl and octyl triesters is practically not toxic after single oral application and dermal application. The oral LD50 is estimated > 3000 mg/kg bw. The dermal LD50 was > 2000 mg/kg. The same is expected for the 1,2,4 -benzenetricarboxylic acid, mixed dodecyl and octyl triesters.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
3 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

The acute toxicity of 1,2,4 -benzenetricarboxylic acid, mixed dodecyl and octyl triesters towards rats was not specifically determined. However, data are available for a structurally related material (1,2,4-Benzenetricarboxylic acid, decyl octyl ester), the only difference being the presence of esters with a shorter alkyl chain (C10 instead of C12). Due to the structural similarity of the test substance compared to the submission substance the available data can be used for read-across. The available data from 2 independent studies demonstrates a lack of toxic effects up to doses far above the limit dose as recommended by current regulatory guidelines. Experimental studies in rats show a very low acute oral toxicity for 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters. No clinical effects were observed at doses of 3000 mg/kg. Mortalities occurred at doses of 17319 mg/kg and above.

An acute dermal toxicity study of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters shows also a low dermal toxicity. No mortalities nor clinical effects were obseved at the limit dose of 2000 mg/kg.

Based on the available data it can be concluded that 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters is of very low acute oral and dermal toxicity.

Justification for classification or non-classification

No classification for acute oral and dermal toxicity is indicated according to the general classification and labeling requirements for dangerous substances and preparations (67/544 EEC) or the classification, labeling and packaging (CLP) regulation (EC 1272/2208).