Registration Dossier

Administrative data

Description of key information

Skin irritation, rabbits:  Not irritating
Eye irritation, rabbits: Not irritating.

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

A dermal irritation test was performed to assess the irritation to skin caused by ADCA (tested under the name of Unifoam AZ SO-NL)(HLS 1988, OCI66/88554D). The study was conducted according to official test guidelines, and in compliance with GLP.

0.5 g of test substance was applied to the skin of six albino rabbits and held in place with a semiocclusive dressing for four hours. At the end of the exposure period, the test substance was washed off with water. The treatment site was observed on days 1 (approximately 30 minutes after removal of the test substance), 2, 3, and 4.

None of the animals showed any response to treatment.

A single semi-occlusive application of AZ SO-NL to intact rabbit skin for four hours elicited no dermal irritation.

Eye irritation

An eye irritation test was performed to determine the potential of ADCA (tested under the name of Unifoam AZ SO-NL)

to cause irritation in the eye (HLS 1988, OCI67/88638D). The study was conducted in accordance with US EPA test guidelines, and in compliance with GLP.

48 mg (the weight equivalent to 0.1 mL) of the test substance was instilled into one eye of each of six New Zealand White rabbits. The untreated eye in each rabbit was used as a reference by which to compare the treated eye. Examinations of the eyes were made 1 hour and 1, 2, 3, 4, and 7 days after instillation. Observation of the eyes was aided by the use of a handheld torch.

None of the animals gave a "positive" response. No corneal damage or iridial inflammation were observed. Mild conjunctival irritation was observed in four of the animals, in one animal at the one hour reading only. The reactions in the other three animals had resolved two days after instillation of the test substance. The remaining two animals showed no response to treatment.

Instillation of Unifoam AZ SO-NL into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria.

Justification for classification or non-classification

ADCA (tested under the name "Unifoam AZ SO-NL") was assessed for skin and eye irritation. The test substance was not found to cause irritation to either skin or eyes, so there is no justification by which to classify ADCA as either a skin or eye irritant.