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EC number: 239-557-1 | CAS number: 15520-11-3
Di-(4-tert-butylcyclohexyl)peroxydicarbonate is not irritating in primary skin and eye irritation tests according to Draize (1944) and FDA-standards (1963), respectively, when applied at a concentration of 0.5 g to the abraded and the intact skin or of 0.1 g instilled into the eyes of albino rabbits.
Table 2: Individual and average skin irritation scores of Bis(4-tert-butylcyclohexyl) peroxydicarbonate
In a primary dermal irritation study, 12 healthy adult New Zealand White albino rabbits were dermally exposed to 0.5 g of Perkadox 16 (Bis(4-tert-butylcyclohexyl) peroxydicarbonate) to an area of 1 inch² on abraded or intact skin of the back of 6 animals in each case. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored according the method of Draize et al. 1944 and the CIVO grading system. No reaction at all was observed. In this study Bis(4-tert-butylcyclohexyl) peroxydicarbonate is not a dermal irritant.
Table 1: Individual scores awarded in the ocular lesions elicited by bis(4-tert-butylcyclohexyl) peroxydicarbonate
After 24 hours
After 48 hours
After 72 hours
After 7 days
In a primary eye irritation study 100 mg of bis(4-tert-butylcyclohexyl) peroxydicarbonate was instilled into the everted lower lid of one eye of 6 New Zealand White albino rabbits for 24 hours. The eyes were not washed after instillation. Animals were observed after 24, 48 and 72 hours and after 7 days. Irritation was scored with the FDA scoring scale. After 24 hours grade 1 of conjunctivae redness and chemosis was observed in all animals. Chemosis was reversible in all animals after 24 hours, redness diminished after seven days. As in terms of conjunctivae irritation scores score 1 is not considered as positive effect and because of the fully reversibility of the effect, bis(4-tert-butylcyclohexyl) peroxydicarbonate is not considered to be an eye irritant.
Primary irritation of the skin was measured by a patch-test technique on the abraded and the intact skin of 12 adult New Zealand White albino rabbits. After an exposure period of 24 hours the patches and the material applied were removed and the resulting skin reactions were evaluated by the method of Draize. A second reading was made 48 hours later (72 hours after application). Since the Draize grading system does not comprise abnormalities found in a second reading after 72 h these were carried out on the basis of the CIVO-grading system. The test material did not cause any signs of skin irritation, neither on the intact skin nor on the abraded skin. According to the Draize and CIVO-grading systems di-(4-tert-butylcyclohexyl) peroxydicarbonate is non-irritating to the skin of rabbits.
In an acute eye irritation study according to FDA-standards, 0.1 g of di-(4-tert-butylcyclohexyl)peroxydicarbonate was instilled into the eyes of six New Zealand White albino rabbits. Eyes were not washed after application. Animals then were observed after 24, 48, 72 hours and 7 days. Irritation was evaluated using the FDA scoring-scale. The test material caused slight redness and slight swelling of the conjunctivae in all rabbits. After 48 h the slight swelling of the chemosis was gone. The slight redness of the conjunctivae was reversible after 7 days. During the seven-day observation period the eye lesions recovered completely. Based on the results of this test and according to the FDA-standard the test material is not considered to be an eye irritant in rabbits.
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