Registration Dossier

Administrative data

Description of key information

Skin irritation studies on isopropyl alcohol in rabbits and guinea pigs have demonstrated that the compound is not a skin irritant. 
Eye irritation studies on isopropyl alcohol in rabbits have demonstrated that the compound is an eye irritant.

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:

 

Isopropyl alcohol did not induce dermal irritation in intact and abraded skin of rabbits or guinea pigs after a single 4-hour occlusive application. A skin irritation study on isopropyl alcohol has been performed in accordance with revised Federal Hazardous Substances Act (FHSA) procedure that had been proposed by the FDA (Nixon et al., 1975).  In this study, rabbits (strain and number of animals not reported) and Hartley guinea pigs (number of animals not reported) were exposed to isopropyl alcohol (vehicle not reported) on the intact and abraded sites (total number of sites tested was 6 for intact skin and 6 for abraded skin) under occlusive conditions.  Animals were exposed to the test compound for 4 hours and observations were recorded at 4, 24, and 48 hours after removal of the patch (washing not reported).   Skin reactions were scored according to a prescribed numerical system (Edwards, 1972) and the primary irritation indice (PII) was calculated by averaging the scores for all test sites.  In addition, tissue destruction was presented as the number of sites that showed tissue destruction or a reaction grade >4.0, excluding actual abrasion, at any grading time and as a function of the total number of sites tested. 

In both rabbits and guinea pigs, the mean score for irritant response was 0 for both intact and abraded skin. The PII was 0 and the tissue destruction fraction was 0 out of 6, whether the skin was intact or abraded. Based on the results of this study, isopropyl alcohol is not a skin irritant. Isopropyl alcohol is not classified as a skin irritant according to the CLP classification criteria. 

Eye Irritation:

 

Eye irritation studies on isopropyl alcohol in rabbits have demonstrated that the compound is an eye irritant. 

An eye irritation study on isopropyl alcohol has been performed in rabbits (Plutnick, 1986).  In this study, 0.1 mL of undiluted isopropyl alcohol was instilled into one conjunctival sac of each of 6 New Zealand White rabbits (3/sex).  Ocular changes were assessed 1, 4, 24, 48, 72 hours and 4, 7, 10, and 14 days after treatment, and scoring was performed according to the guideline methods with additional parameters assessed for the conjunctivae and cornea.  Instillation of isopropyl alcohol caused conjunctival, corneal, and iridial responses in all animals. Conjunctival responses, including redness, chemosis, and clear/white discharge were observed in all animals 1 hour after treatment. Specificially, redness was noted in all animals from 1 hour after treatment through to Day 10. Although the incidence of redness was observed to be decreased at study termination (Day 14), redness was still noted in 3 animals. Chemosis was noted in all animals from 1 hour through to 48 hours after treatment. The incidence of chemosis decreased afterwords and chemosis was not noted on Day 14. Clear and/or white discharge was noted in all animals at the 1 and 4 hour observations and was fully reversed by Day 4. Conjunctival ulceration was noted in 5 animals during the study. Iridial responses were noted in all animals during the study and were reversed by Day 7. Corneal responses including, opacity and stippling, were observed in 5 animals. Corneal ulceration was noted in all animals. Corneal responses in all animals were reversed by Day 7. Other observations noted during the study included dye retention of the nictitating membrane and conjunctiva and conjunctival blistering. Ocular irritation was most prominent from 1 hour after treatment through to Day 4. The total Draize score ranged from 4 to 25. Three of the 6 rabbits displayed conjunctival redness on Day 14. Under the conditions of this study, isopropyl alcohol was considered to be irritating to rabbit eyes. 

According to CLP classification criteria, isopropyl alcohol is classified ascategory II (causes serious eye irritation).

 

In another eye irritation study conducted with rabbits (Eye Irritation: Reference chemicals data bank, 1998), undiluted isopropyl alcohol was instilled into 4 rabbits (strain not reported), and ocular changes were assessed 24, 48, 72 hours and 7 and 10 days after treatment. Ocular changes were scored against the maximum average scoring system of Draize (1944). The modified maximum average scored at 1 day was 30.5 out of a possible score of 110. Effects were fully reversed in 10 days. Therefore, isopropyl alcohol is irritating to rabbit eyes. 

According to CLP classification criteria, isopropyl alcohol is classified as category II (causes serious eye irritation).



Effects on eye irritation: irritating

Justification for classification or non-classification

 Skin irritation: The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.

Eye irritation: according to CLP calssifcation criteria, the substance does meet the criteria for classification and labelling for this endpoint (category II: causes serious eye irritation) as set out in Regulation (EC) No. 1272/2008.