Registration Dossier

Administrative data

Description of key information

Both the oral and dermal toxicity test revealed LD50 > 2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

In 1996 laboratories of Ciba, Switzerland, performed oral and dermal acute toxicity tests with the test item CA 2342 A. 2000 mg/kg bw was the highest test item dose being tested (limit test). Both the oral and dermal toxicity test revealed LD50 > 2000 mg/kg bw. There were no in-life observations indicating treatment-related systemic effects. All animals survived to scheduled sacrifice.

Justification for classification or non-classification

The substance is not classified as acute toxic by EU-GHS (CLP), since LD50 > 2000 mg/ kg body weight, which is the cut-off in the EU's GHS classification system for acute oral and dermal toxicity.

UN-GHS has a Category 5 for acute oral toxicity for the dose range 2000 mg/kg bw < LD50 < 5000 mg/kg bw, a concentration range which has not been tested. However acute toxicity Category 5 is applied by some authorities only. Furthermore, acc. to GHS 3.1.2.5 testing animals in the Category 5 range is discouraged unless "there is a strong likelyhood that results of such testing would have a direct relevance to the protection of human health", which is not the case.