Perhydroazepine

Endpoint summary

Description of key information

Skin and eye irritation studies on the submission substance have demonstrated that the compound is corrosive to skin and caused severe damage of the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

A skin irritation/corrosion test was performed with six rabbits. The animals were exposed to 0.5 ml of test substance (20% solution in water) on the clipped skin under occlusive conditions for 4 h. The skin reaktions were observed for 48 h after the initial exposure. All six animals showed skin corrosion.

The same test was performed with undiluted test substance. The result was the same.

Another skin irritation/corrosion test was performed with six rabbits. The animals were exposed to 0.5 ml of test substance on clipped and clipped plus abraded skin under occlusive conditions for 4 h. The skin reaktions were observed for 48 h after the initial exposure. All six animals showed severe skin corrosion, the scores for erythema and edema for all animals were at all reading times 4/4.

Another study supported the results. This study was performed with six rabbits. The animals were exposed to 200 mg/kg bw of test substance on the clipped skin under occlusive conditions for 24 h. Severe erythema with blanching and severe edema with pocketing were observed on day 1 (no individual scores given). The skin irritation score was not evaluated after day 1, since the pH of the test substance was found to be greater than 12. One animal died between day 8 and 14. At day 14 eschar at the application site was observed in all surviving rabbits.

An eye irritation/corrosion test was performed with six rabbits. The animals were exposed to 0.1 ml of test substance. 24 h after application all 6 animals exhibited blanching of the nictitating membrane and eschar of the eyelids. in addition, 3 of the rabbits had blanching of the conjunctiva, while the conjunctiva of the remaining rabbits was not visible due to eschar on the eyelids.The iris of all rabbits was unscorable due to severity of the opacity. After 24 h the study was terminated due to the strong corrosive effects.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to the results of available data the submission substance fulfills the criteria to be classified as skin corrosive substance following criteria of Regulation (EC) No. 1272/2008 (CLP). Due to the strong corrosive effect after 4 h exposure and the fact that short term exposure data are missing in all studies (3 min and 1 h) the most conservative presumption is to classsify the submission substance in subcategory 1A.

According to the results of all available data the test item fulfills the criteria to be classified to cause irreversible damage to the eyes (Cat. 1) following the criteria of Regulation (EC) No. 1272/2008 (CLP).

According to Council Directive 76/548/EEC the submission substance hast to be classified as corrosive to skin as well as irritant, which imposes the risk of serious eye damage based on the available results.