Registration Dossier

Administrative data

Description of key information

Oral: LD50: > 2000 mg/kg bw for rat
Dermal: LD50: > 2000 mg/kg bw for rat

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Two toxicological studies were performed with the registered substance, the first one follows both the OECD Guideline 420: acute oral toxicity - fixed dose method and OECD Guideline 401: acute oral toxicity while the second one follows the OECD Guideline 402: acute dermal toxicity, in a certified GLP lab. So the reliability of this data can be ranked as klimisch code 1: reliable without restrictions. On the basis of this analysis, those studies can be chosen as the key studies.

Justification for classification or non-classification

According to Official Journal of the European Union 1272/2008 (CLP) dated December 16th 2008, isosorbide is non-classified in the acute toxicity hazard categories.