Registration Dossier

Administrative data

Description of key information

A Primary Skin Irritation study and an Eye Irritation study have been conducted on ADONA.  The substance was severely irritating to the eyes and non-irritating to the skin.

Key value for chemical safety assessment

Additional information

A Primary Skin Irritation study and an Eye Irritation study have been conducted on ADONA. The substance was severely irritating to the eyes and non-irritating to the skin.

 

Eye irritancy/corrosivity of ADONA was assessed in rabbits according to OECD Test Guideline 405. Single samples of 0.1 ml of the test substance were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation. Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (50-75% of the corneal area). As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent 7 and 14 days after instillation in two animals. The corneal injury had resolved within 7 days in one animal and within 21 days in the other two animals. lridial irritation grade 1 was observed and had resolved within 7 days in all animals. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 21 days in one animal and within 14 days in the other two animals. Under the conditions of the study, the test substance caused severe eye irritation which was fully reversible within 21 days. Based on these results ADONA should be classified as irritating to eyes (Category 2A according to GHS criteria.

 

Skin irritation of ADONA was assessed according to OECD Test Guideline 404. Three rabbits were exposed to 0.5 ml of the test article, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. Exposure to the test material resulted in well defined erythema in the treated skin-area of the rabbits which had resolved within 48 hours in two animals and within 72 hours in the other animal. No edema was noted. Under the conditions of the test, ADONA caused slight to well-defined erythema when applied to the skin of rabbits. ADONA does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EC criteria for classification and labelling requirements for dangerous substances and preparations.

Justification for classification or non-classification

ADONA meets the DSD criteria for classification as an eye irritant (Xi; R36), and it meets the CLP criteria for classification as Eye Irrit. 2.

 

ADONA does not meet the DSD or the CLP criteria for classification as a skin irritant.