Registration Dossier

Administrative data

Description of key information

Dermal applications in rabbits or guinea pigs produced only slight skin irritation effects.  The subject chemical was a moderate eye irritant in the rabbit with effects resolving within 14 days.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation

In a key study in rabbits, administration of the subject chemical to the ear and shaven, intact and abraded skin of white rabbits produced no to only minimal irritant effects. In a supporting study, occlusive administration of the subject material in guinea pigs produced only slight irritation. Repeated dermal application to guinea pigs for 10 days exacerbated the effect, with slight to moderate skin irritation evident with possible defatting.

Eye Irritation

In a key study in rabbits, administration of the subject chemical undiluted to the eye (unwashed) produced moderate conjunctival swelling, corneal damage and slight irritis which did not subside in 7 days. In a supporting study, administration in rabbits undiluted produced moderate to strong eye irritation with severe erythema and slight to moderate edema of the conjunctiva, iritis and staining of adnexae and cornea. Some degree of corneal opacity was seen in all eyes tested. All signs resolved by 14 days.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

The subject chemical would not be rated a primary dermal irritant under the EU DSD criteria (EU Directive 67/548/EEC). It would also not be classified for skin irritation under the EU CLP criteria (EU Regulation 1272/2008) or the UN GHS criteria.

The subject chemical would be rated an eye irritant under the EU DSD criteria (EU Directive 67/548/EEC); R36 (irritating to eyes). It would also be classified for eye irritation (Category 2) under the EU CLP criteria (EU Regulation 1272/2008), and 2A according to the UN GHS criteria.