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KMID : 1023120100080010031
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Korean Journal of Aesthetic Society
2010 Volume.8 No. 1 p.31 ~ p.40
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Skin Irritation and Skin Sensitization Studies on Sol-M® Powder
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Lee Hye-Sook
Hwang Seok-Youn
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Abstract
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The use of atopic agents has been recently increased in various kinds of products, although there were some reports that atopic agents might cause allergic contact dermatitis. This study was conducted to investigate the skin irritation and skin sensitization induced by Sol-M® which contains Angelicae Dahuricae Radix, Phellodendri Cortex, Pinus densiflora Sieb., Mori Cortex Radicis in rabbits and guinea pigs according to Korea Food and Drug Agency(KFDA) guidelines for toxicological test. GPMT(The Guinea Pig Maximization Test) method was applied to evaluate the sensitization potential of Sol-M® in Hartley guinea pigs. In primary skin irritation test, rabbits were treated with 5 %, 10 % and 20 % of Sol-M® for 24 hrs. Sol-M® did not induced any adverse reaction such as erythema and edema on intact skin sites, but on abraded skin sites, some rabbits showed edema 24 hrs after topical application. So 5 %, 10 % and 20% of Sol-M® was classified as a practically non-irritating material based on the score 0.21, 0.33 and 0.27 of primary irritation index. In the sensitization test, guinea pigs were sensitized with intradermal injection of 0.1 ml Sol-M® for 24 hrs. After 1 week, Sol-M® was treated on the site of injection and challenged 2 weeks later. 10 % and 20 % of Sol-M® was classified to grade Ⅲ and Ⅴ, indicating moderate and extreme sensitizers, respectively. From results of the present study, it is suggested that 10 % Sol-M® is a practically-safe material to skin without potential of irritation and sensitization.
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KEYWORD
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Sol-M®, skin irritation, sensitization, The Guinea Pig Maximization Test(GPMT)
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