Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion in vivo: OECD 404, EU B.4: not irritating. 
Eye irritation/corrosion in vivo: OECD 405, EU B.5: highly irritating.
The read-across to the results with fumaric acid do not indicate a local effect to the respiratory tract.

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:
adverse effect observed (irritating)

Respiratory irritation

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

Additional information

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The test substance was not irritating to the skin, but highly irritating to the eyes of the rabbits.

The skin irritation test in three rabbits reported no dermal reactions and so no classification is necessary for skin irritation according to GHS and DSD.

Corneal and conjunctival changes persisted to termination and result in classification with R41, Risk of serious damage to eyes (DSD) and Category 1: Irreversible effects on the eye (GHS).

The read-across to the results with fumaric acid do not indicate a local effect to the respiratory tract.

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