Registration Dossier

Administrative data

Description of key information

Skin Irritation:Slightly Irritating, Rabbit, OECD 404, 
Eye Irritation: Moderately irritating, Rabbit, OECD 405.

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

The in-vivo studies were performed for a chemical registration scheme outside of the European Economic Area. Unreliable screening studies which were not conducted for the purposes of REACH were discarded. Only studies conducted according to guidelines and under OECD GLP were selected as key studies for use in classification.

Skin Irritation:

The primary skin irritation potential was investigated according to the OECD 404 (2002), OPPTS 870.2500 (1998) and EC No 440/2008, B.4 (2008). The primary irritation index was 1.22. At the 1, 24, 48 and 72 hours observations and one week observation, well-defined erythema (score 2) was noted in one animal. Slight oedema (score 2) was observed in one animal at the 1 hour observation which resolved to very slight oedema (score 1) at the observations 24, 48, 72 hours and 1 week after removal of the dressing. Very slight oedema was observed in the other two animals at the 1 hour interval and then only in one animal, 24 and 48 hours after removal of the dressing. Two weeks after removal of the dressings, all animals had fully recovered and showed no signs of skin irritation. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed 2 weeks after patch removal, the study was terminated after the 2 weeks observation. The body weights of all rabbits were considered to be within the normal range of variability. The application of the test substance caused signs of skin irritation which persisted for up to one week after application in one animal. According to the Draize classification criteria test item is considered to be a “mild-irritant” to rabbit skin (P.I.I. = 1.22).

Eye Irritation:

In a primary eye irritation study, 0.1mL of the test substance was instilled into the conjunctival sac of the left eye of each of 3 adult male New Zealand White rabbits. The untreated right eyes served as the control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours and 1 week after test material instillation. Observations with fluorescein staining were made at approximately 24 hours before treatment and then 24, 48, 72 hours and 1week after treatment. Initial Pain Reaction (IPR) scores were taken after the treatment of the test item and a score of 1 or 2 was observed in the animals. Discharge was observed in all animals at the 1, 24 and 48 hour observations and in two animals, 72 hours after treatment. Conjunctival redness was observed in all 3 animals up until 72 hours after treatment. Chemosis was seen in all animals at the 1 and 24 hour observation which persisted in one animal until the 72 hour observation. No other signs were observed and all animals were symptom free 1 week after treatment. Fluorescein staining was negative in all animals during the experiment. During the study, the control eye of all animals was symptom-free. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability. The test substance was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.

The data provided for this endpoint is considered to be relevant, adequate, reliable and complete for the purposes of classification and risk assessment.

Justification for classification or non-classification

The classification is based on “mildly irritating” is based on the Draize classification criteria.

Based on the scoring results and the reversibility of the effects the test substance is not classified as a skin irritant according to CLP (regulation (EC) No 1272/2008) .

Based on the scoring results and the reversibility of the effects the test substance is not classified as an eye irritant according to CLP (regulation (EC) No 1272/2008).