Abstract |
The test article, API 83-15, was applied to the shaved intact skin of New Zealand White rabbits three times a week for a total of 12 applications over a 28-day period. The test article was applied at dose levels of 200 (Group 2), 1000 (Group 3), and 2000 (Group 4) mg/kg to groups of five male and five female rabbits. In addition, five male and five female rabbits served as sham-treated negative controls. All animals were observed twice daily for toxic and pharmacologic signs; dermal irritation was scored daily (according to the Draize System (a)). Body weights were measured and recorded for each rabbit at the end of the quarantine period, at weekly intervals during the study, and prior to termination. |