Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
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.