Initial Submission: Letter from Elf Atochem NA to USEPA regarding Preliminary Results of Skin Irritation Study in Rabbits with Lupersol 546-M75, dated 01/10/1996

摘要

The potential irritant and/or corrosive effects of Lupersol 546-M75 were evaluated on the skin of New Zealand White rabbits. Each of six rabbits received a 0.5 mL dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi-occIusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water. Test sites were subsequently examined and scored for dermal irritation for up to 21 days following patch removal. Exposure to the test article produced well-defined erythema and/or focal/pinpoint to severe blanching and very slight to severe edema on 6/6 test sites at the 1 hour scoring interval. The dermal irritation progressed to focal/pinpoint to severe eschar on 2/6 test sites by study day 7. The dermal irritation resolved completely in 2/6 test animals by study termination (day 21). Additional dermal findings noted during the study period included desquamation and eschar exfoliation, which were noted on 6/6 and 1/6 test sites, respectively. Under the conditions of this test, Lupersol 546-M75 is considered to be an irritant to the skin of the rabbit. Although severe irritation was noted in the test animals, only 4/6 animals had very slight erythema remaining at the day 21 scoring interval. These were not considered irreversible changes; therefore, the test article was not considered corrosive.