US EPA

8236684 

Journal Article 

Skin sensitization study of eperisone hydrochloride tape (E2000) in guinea pigs by using the adjuvant and patch test 

Iwata, T 

1997 

0 

Yakuri to Chiryo / Japanese Pharmacology and Therapeutics
ISSN: 0386-3603 

25 

4 

113-116 

Japanese 

Skin sensitization study of E2000 was performed according to adjuvant and patch test method. E2000 (1.5 x 1.5 cm 2) was occlusively applied once a day for three consecutive days to the shaved skin of the dorsal neck of 10 guinea pigs. Eight days after the initial application, E2000 was occlusively applied for 48 hours to the same site in order to sensitize. Twenty-one days after the initial application, E2000 (1.5 x 1.5 cm 2) was occlusively applied for 24 hours to the shaved flank skin of guinea pigs in order to challenge exposure. The skin was observed macroscopically at 0, 24 and 48 hours after removal of the patch. Skin reaction was evaluated according to Sato's criteria. Stress -tested E2000 (60°Cx1 month), E2000 base and 0.1% 1- chloro-2,4-dinitrobenzene were also tested in a similar manner. In the skin sensitization study in guinea pigs, E2000 produced very slight to severe erythema with slight eschar formation in the patched skin in 7 of 10 animals tested, and stress-tested E2000 produced very slight to severe erythema in the patched skin in all animals. No skin reaction was observed on application of E2000 base. 0.1% 1-chloro-2,4-dinitrobenzene produced severe erythema with slight eschar formation and slight to severe edema. As a result, E2000 and stress-tested E2000 produced sensitization in guinea pigs : the degree of sensitizing potential was 1.2 and 1.6, respectively according to Sato's criteria. 0.1% 1-chloro-2,4-dinitrobenzene produced clear sensitization according to Sato's criteria, with a mean response of 5.6. 

Eperisone hydrochloride; Guinea pig; Skin sensitization study