Registration Dossier

Administrative data

Description of key information

The substance was not irritating to skin in rabbits but caused serious damage to eyes of rabbits.

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:
adverse effect observed (irritating)

Additional information

Skin irritation

An acute dermal irritation GLP study according to OECD guideline 404 was conducted in 3 female Japanese White rabbits in order to evaluate the irritation and corrosion effects of EEA-NH4 on the skin (Kannami Laboratory, 2008). In this study 0.5 g of the test substance was applied to a lint sheet (2.5 x 2.5 cm) and moistened by 0.5 ml of water for injection and then it was applied to the clipped dorsal skin of rabbits for 3 minutes, 1 hour or 4 hours. Animals were observed periodically for dermal reactions including the corrosion reactions according to the Draize method.

There was no tissue damage such as necrosis, ulcer, hemorrhage and hemorrhagic eschar formation at any site after exposure to the test substance for 3 minutes, 1 hour or 4 hour.

An exposure of 3 minutes did not result in dermal reactions at 1 or 24 hours after removal of the test substance. An exposure of 1 hour did not result in dermal reactions at 1, 24, 48 or 72 hours after removal of the test substance. An exposure of 4 hours resulted in erythema (score of 1) in 2 animals at 24 hours after removal of the test substance. However, the erythema was no longer observed 48 hours after removal of the test substance. No edema was observed at any time period after 4 hours exposure to the substance.

No abnormalities regarding clinical signs and body weight were observed in any animal.

Eye irritation

An acute eye irritation GLP study according to OECD guideline 405 was conducted in female Japanese White rabbits in order to evaluate the irritation and corrosion effects of EEA-NH4 on the eyes(Kannami Laboratory, 2008). In step 1, 0.1 g of the test substance which was pulverized in a mortar was applied to the left eye of 1 rabbit but no corrosive change was observed in the animal at 1 or 24 hours after application. Therefore, 2 other animals received the test substance in the same manner in step 2.

In all animals, corneal opacity, iridal change, and conjunctival redness, chemosis and discharge were observed at 1 hour after application. The irritation reactions were observed similarly up to day 9 after application. The irritation reactions showed a slight tendency toward decrease from day 10 after application and iridal change and conjunctival chemosis were no longer observed by day 12 and by day 16 after application respectively. Conjunctive discharge was no longer observed by day 21 after application (the final day of observation). However, corneal opacity was observed in all animals and conjunctival redness in 1/3 animals and the irritation reactions were not completely removed. For the other ocular changes, eyelid closure was observed in all animals immediately after application and in 1/3 animals from 1 hour to day 4 after application. Additionally, corneal vascularization was observed in 1/3 animals on day 6 after application and in all animals from day 7 to day 21 after application. Since corneal opacity and conjunctival redness were not completely removed the substance was considered to cause severe damage to the eyes.

No test substance related effects in any animal were observed regarding clinical signs and body weights.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the irreversible effects observed in the eye irritation test, the substance has to be classified according to Directive 67/48/EEC as Xi – R41 (Risk of serious damage to eyes). In accordance to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the substance has to be classified for Eye damage, Cat. 1 - H318 (Causes serious eye damage). No classification for skin irritation is warranted based on the available in vivo skin irritation study.