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Administrative data

Description of key information

An acute eye irritation and dermal irritation study are not available for the chemical NaDMH. Instead results for acute eye irritation and dermal irritation for the analogue chemical DMH are provided.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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 either 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.

These studies have been performed on DMH (Dimethyl Hydantoin) and have been used for read-across purposes. A summary of data for read-across of NaDMH with DMH is given in Section 13.

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