Registration Dossier

Administrative data

Description of key information

Guidelined in vivo (rabbit) studies (OECD 404 and 405)

Guidelined in vitro studies (OECD 431, 439 and 492)

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

Justification for classification or non-classification

skin irritation/corrosion: no adverse effect observed (not irritating)

eye irritation: No relevant eye-irritating effects in the in vivo test in rabbits and in the Isolated Chicken Eye Test (OECD 438) were noted with the undiluted test item. The result of OECD 492 is only based on an increased cytotoxicity.

The results of OECD 438 and 405 are based on histopathological examination and revealed no eye irritating potential. Therefor the result of OECD 492 will be regarded as false positive. OECD 438 and 405 will be used for the non-classification: Hydroxyethyl-2-nitro-p-toluidine is not classified as irritating to eyes.