Product Details

FHSA Primary Skin Irritation

Date: May 7, 2003
Test device: Gauze, zonas porous tape, dental dam/rubber sheeting, Micropore surgical tape, 25 gauge needle.

This study is designed to show the degree of skin irritation caused by the test article under evaluation.

Six New Zealand White rabbits were used in the test. Twenty four hours prior to dosing, the hair on each animal's back was removed with clippers. One inch square pieces of the test article were cut and applied to intact and abraded areas on the skin of each animal. The squares of test article were held in place with surgical tape. To protect the dosing sites and to promote occlusion, the trunks of each animal were wrapped with gauze, which was held in place with zonas tape. The gauze was then wrapped with an elastic bandage.

After 24 hours, the animals were unwrapped and the article removed. The test sites were observed and scored 24 and 72 hours after dosing. Based on the scores, a Primary Irritation Index was calculated in order to evaluate the material's potential to be a primary irritant.

RESULT

Primary Irritation Score was 0. The test article is NOT a primary irritant.