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EC number: 615-229-7 | CAS number: 70969-57-2
In the test group and the irritation control animals, the 3 intradermal injections of the intradermal induction produced slight to moderate redness around the injection sites at either 1 and 24 h after injection. The topical application of 100% of the test substance for 24 h under occlusive conditions leads to very slight to well-defined erythema in 18/20 animals and severe erythema to slight eschar formation in one animal at the 1 and 24 h observations. Moderate to severe erythema formation was observed in one animal after 24 h. At the 1 h reading, very slight to slight edema were noted in 12/20 animals. At the 24 h reading, very slight to moderate edema were observed in 19/20 animals.
The topical application of peanut oil produced results similar to the treated animals. In all 10 irritation control animals, very slight to severe erythema and very slight to slight edema were noted at the 1 and 24 h observation time points.
The topical challenge dose of 50% test substance in peanut oil leads to very slight erythema in 11/20 animals and to well-defined erythema in 7/20 animals at the 24 h evaluations in test group animals. At the 48 h reading, 6/20 animals had very slight erythema, one animal had well-defined erythema and 13/20 animals were free of erythema. Very slight edema were observed in 4/20 treated animals at the 24 h observation and in one animal at the 48 h observation. In the irritation control group, the topical application of 50% test substance in peanut oil produced very slight erythema in 4/10 animals and well-defined erythema in 5/10 animals at the 24 h reading. At the 48 h observation, 6/10 animals had very slight erythema and one animal had well-defined erythema. Edema was not observed in any irritation control animal at the 24 or 48 h reading.
Since the severity of the erythema was similar between the treated group and the irritation control group and the incidence of erythema was higher in the irritation control group, the response was considered an irritation response and not a sensitization response. An examination of the individual animals' responses showed that the majority of the irritation scores decreased from the 24 h evaluation to the 48 h evaluation, which also is indicative of an irritation and not a sensitization response. However, since there was some irritation from the challenge application, it was decided to rechallenge at a lower concentration to confirm that the test material possessed no sensitization potential.
The rechallenge was performed with 10% test substance in peanut oil and produced very slight erythema in 4/20 animals at the 24 h observation. All animals were free of erythema at the 48 h evaluation. Edema was not observed in any treated animals at the 24 or 48 h observations.
In the irritation control group, topical application of 10% test substance in peanut oil leads to very slight erythema in 4/10 animals and well-defined erythema in one animal at the 24 h observation. All animals were free of erythema at the 48 h evaluation. Edema were not observed in any irritation
control animal at the 24 or 48 h observations.
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