Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: not irritating
Eye irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation/corrosion:

A test of the registered substance was performed on skin irritation/corrosion in vivo according to OECD Guideline 404: acute dermal irritation/corrosionin a certified GLP labs. The study can be ranked as klimisch code 1: reliability without restrictions. The results showed that no toxic effect was found, so the irritative effect of isosorbide can be concluded as no irritating.

Eye irritation:

An in vivo test of the registered substance was performed on eye irritation complying with OECD Guideline 405: eye irritation/corrosion for identifying ocular corrosives and severe irritants. This study is regarded as key study as it can be ranked as klimisch code 1: reliability without restrictions. And the test result showed that isosorbide is not irritating.

Justification for classification or non-classification

Skin irritation/corrosion:

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

Eye irritation:

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