A 26-WEEK REPEATED PERCUTANEOUS DOSE TOXICITY STUDY OF CALCIPOTRIOL (MC903) IN DOGS

• Published in: Journal of toxicological sciences Vol. 21; no. SupplementII; pp. 365 - 387
• Main Authors: IMAIZUMI, Takashi, TSURUTA, Masaaki, KOIKE, Yoshihide, ONO, Masahiro, SHIRAKAWA, Kiyomi, NAGATA, Mitsuhiro, KONISHI, Ryoji
• Format: Journal Article
• Language: English; Japanese
• Published: Tokyo The Japanese Society of Toxicology 01.07.1996; Japanese Society of Toxicology
• Subjects: Administration, Cutaneous; Animals; Beagle dogs; Calcitriol - administration & dosage; Calcitriol - analogs & derivatives; Calcitriol - toxicity; Calcium - urine; Dermatologic Agents - administration & dosage; Dermatologic Agents - toxicity; Dogs; Drug Administration Schedule; Female; Hyperplasia; Keratosis - chemically induced; Male; Pruritus - chemically induced; Skin - drug effects; Skin - pathology
• ISSN: 0388-1350; 1880-3989
• DOI: 10.2131/jts.21.SupplementII_365

A 26-week repeated percutaneous dose toxicity of calcipotriol (MC903), an anti-psoriasic agent, was studied in beagle dogs at doses of 0.04, 0.4 and 4 μg/kg/day. 1. In general conditions, reddening, rash, desquamation, pruritus, wet and hot skin at 4 μg/kg/day, reddening, rash and desquamation at 0.4 μg/kg/day, pruritus and desquamation at 0.04 μg/kg/day, were observed at the skin of application site. 2. In urinalysis, an increase or a tendency to an increase in Ca level, were observed at 4 μg/kg/day. 3. Histopathological examinations revealed squamous cell hyperplasia and para-keratosis at the skin of application site in both sexes at 4 μg/kg/day. However, these findings were not shown at the skin of application site at 0.4 and 0.04 μg/kg/day. 4. On the basis of results obtained in the present study, it is considered that 0.4μg/kg/day is the no-toxic dose of MC903 applied percutaneously in both sexes of beagle dogs.