Registration Dossier

Administrative data

Description of key information

An acute eye irritation and dermal irritation study are available

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

The substance was not classified under criteria defined in Regulation (EC) 1272/2008, as no irritating effect was observed on application to rabbit skin.

The application of the substance to the rabbit eye did not produce any effect to cornea or iris of the eye. A Conjunctivae effect was reversible within 7 days, showing an irritation effect of DMH to the eye with no corrosive effect. All findings were reversible, as the severity of each reaction decreased over seven days. 5,5-dimethylhydantoin does not need to be classified for eye irritancy.

Justification for classification or non-classification

The substance was not classified neither for skin irritation nor for eye irritation under criteria defined in Regulation (EC) 1272/2008, as no irritating effects were observed on application to rabbit skin and rabbit eye.