Registration Dossier

Administrative data

Description of key information

Skin irritation: OECD TG 404: No erythema, edema observed.
Eye irritation: OECD TG 405: No corneal opacity, iritis, conjunctival erythema or chemosis observed.

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

In the key primary dermal irritation study according to OECD TG 404 and GLP, young adult white rabbits (4 females) were dermally exposed to unchanged octocrilene for 4 hours (Symrise 1992036).  No erythema and edema were observed during the observation period (72 hours) with the unchanged test material or at lower concentrations of 1, 10, 25, and 50% (vehicle: 96% ethanol/diethyl- phthalate).

Eye irritation

In the key primary eye irritation study according to OECD TG 405 and GLP, unchanged octocrilene was instilled into the conjunctival sac of the left eye of young adult Russian rabbits (4 females) for 24 hours (Symrise 1992037). The eyes were washed after the instillation of a fluorescent dye 24 hours after treatment, and before eye inspection. No adverse reactions to the eye were noted in any of the animals during the observation period (72 hours). 

Justification for classification or non-classification

The present data on skin and eye irritation do not fulfill the criteria laid down in 67/548/EEC and CLP, and therefore, a non-classification is warranted.