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EC number: 200-661-7
CAS number: 67-63-0
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.
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
Eye irritation studies on isopropyl
alcohol in rabbits have demonstrated that the compound is an eye
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.
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.
to CLP classification criteria, isopropyl alcohol is classified as category
II (causes serious eye irritation).
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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