Registration Dossier

Administrative data

Description of key information

Skin irritation studies on isopropyl chloride in rabbits, which were performed according to test guidelines and in compliance with GLP, have demonstrated that the test compound is not a skin irritant.

An eye irritation study on isopropyl chloride in rabbits, which was performed according to test guidelines and in compliance with GLP, has demonstrated that the test compound is slightly irritating to rabbit eyes; however, the effects were fully reversible within 24 or 48 hours.

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/Corrosion

The skin irritation potential of isopropyl chloride was evaluated in rabbits in a GLP-compliant study performed according to OECD Guideline for the Testing of Chemicals No. 404 (Holloway, 1990). In this study, 3 New Zealand White rabbits were exposed to a single application of 0.5 mL of undiluted isopropyl chloride on the shaved back under semi-occlusive conditions for a period of 4 hours. After the exposure period, the dressing was removed and any residual sample was carefully washed away with water or an appropriate solvent. The skin reaction was assessed according to the prescribed numerical system described in the test guideline at 30 to 60 minutes, 24, 48, and 72 hours. No edema or erythema was observed for any animal at any time-point. Based on the results of this study, isopropyl chloride is not a skin irritant to rabbit skin. Furthermore, isopropyl chloride is not classified as a skin irritant according to CLP criteria. 

An additional skin irritation study, which was GLP-compliant and performed according to test guidelines, was conducted on isopropyl chloride in rabbits (Chibanguza, 1989). A single application of 0.5 mL undiluted isopropyl chloride was applied on the right (intact) and left (scarified) back of 6 New Zealand White rabbits for a 4-hour period. After removal of the bandage, residual test substance was removed with water. The skin reactions were scored at 4, 24, 48, and 72 hours for both intact and scarified skin. No edema or erythema was reported for any animal at any time-point. Under the conditions of this study, isopropyl chloride is not a skin irritant to rabbit skin. According to CLP criteria, isopropyl chloride is not classified as a skin irritant. 

 

Eye Irritation

An eye irritation study on isopropyl chloride has been conducted in accordance with OECD Guideline for the Testing of Chemicals No. 405 and in compliance with GLP (Sterner and Chibanguza, 1989). In this study, 0.1 mL of undiluted isopropyl chloride was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits. The treated eye of 3 rabbits was washed out 4 seconds following the application of the test compound with lukewarm water. The ocular reactions were evaluated at 1, 24, 48, and 72 hours after treatment. The eyes were also examined for potential eye lesions at 24 and 72 hours post-administration. Slight eye irritation was observed, the effects of which were fully reversible within 24 or 48 hours. According to CLP criteria, isopropyl chloride is not classified as an eye irritant.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Skin Corrosion / Irritation: The results of the in vivo test in rabbits according to OECD TG 404 indicate that the submission substance was not a skin irritant. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.2.

 

Serious Eye Damage / Eye Irritation: The results of the in vivo test in rabbits according to OECD TG 405 indicate that the submission substance was not an eye irritant. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.2.