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Description of key information

A skin irritation study was conducted using three female rabbits exposed to 0.5 ml of test substance on the dorsal area of the trunk for four hours and extended observations made for up to 21 days. Mild to moderately severe edema and erythema were noted but were generally reversible by either 7 or 21 days. at the 1, 24, 48, and 72 hr observations.  The test substance is therefore classified as a Category 2 skin irritant. Similarly, rabbits were exposed to 0.1 ml of 100% test substance in the eye for 24 hrs. Results show that the test substance may cause serious damage to the eyes which was not reversible and therefore the substance is classified as corrosive.

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

Three female rabbits were exposed to 0.5 ml of test substance on the dorsal area of the trunk for four hours. After four hours, the test substance was removed by washing with lukewarm water. Observations for erythema and edema were made 0.5-1, 24, 48, and 72 hrs. Since adverse effects were not fully resolved by the 72 hr observation, further observations were made at 7, 14, and 21 days. Mild to moderately severe edema and erythema were noted at the 1, 24, 48, and 72 hr observations. Erythema and edema cleared by the 7 day observation, but the erythema returned by the 14 day observation. This was clearing by the 21 day observation. The test substance is classified as a Category 2 irritant according to EU DSD and CLP guidelines.

Similarly, rabbits were exposed to 0.1 ml of 100% test substance in the eye for 24 hrs. Results show that the test substance may cause serious damage to the eyes.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the results of an in vivo skin irritation study, CaDDBS is classified as R38 according to the DSD and as Category 2 irritant (H315) under the CLP guidelines. In addition, CaDDBS is classified as R41, may cause serious damage to the eyes, under the DSD and Eye damage 1 (H318) under the CLP.

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