치약 및 함유 성분의 구강 점막 자극 평가를 위한 새로운 in Vitro 시험법 적용
Application of New in Vitro Test Method to Evaluate the Oral Mucosal Irritation for Toothpaste and its Ingredients
2
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Oral hygiene products, such as toothpastes, are essential for personal hygiene. However, these products contain substances that cause mucosal irritation but are essential to maintain functionality. Until now, there is no in vitro animal test to evaluate oral mucosal irritation for oral hygiene products and its ingredients. Moreover, oral hygiene products are classified as cosmetics in EU, thus the irritation test for these products and its ingredients are prohibited. In Korea, oral products are classified as quasi-drugs now, but there is a high possibility to change to cosmetics according to global trends. So we needed to set up the in vitro test system to evaluate oral mucosal irritation and we studied the oral mucosal irritation for toothpaste and its ingredients by agar diffusion test. In the evaluation of ingredients, the use of surfactant, tooth whitening ingredient and some functional ingredients affect the increase of cytotoxicity. In addition, when diluted to 25%, the toothpastes showed the broad range of irritation and it was appropriate to judge the level of irritation. From the results, we can set the evaluating method for toothpaste and its ingredients and internal criteria for the mucosal irritation at same time.
Abstract
Oral hygiene products, such as toothpastes, are essential for personal hygiene. However, these products contain substances that cause mucosal irritation but are essential to maintain functionality. Until now, there is no in vitro animal test to evaluate oral mucosal irritation for oral hygiene products and its ingredients. Moreover, oral hygiene products are classified as cosmetics in EU, thus the irritation test for these products and its ingredients are prohibited. In Korea, oral products are classified as quasi-drugs now, but there is a high possibility to change to cosmetics according to global trends. So we needed to set up the in vitro test system to evaluate oral mucosal irritation and we studied the oral mucosal irritation for toothpaste and its ingredients by agar diffusion test. In the evaluation of ingredients, the use of surfactant, tooth whitening ingredient and some functional ingredients affect the increase of cytotoxicity. In addition, when diluted to 25%, the toothpastes showed the broad range of irritation and it was appropriate to judge the level of irritation. From the results, we can set the evaluating method for toothpaste and its ingredients and internal criteria for the mucosal irritation at same time.
참고문헌 (10)
- Babich H, "Sodium lauryl sulfate and triclosan: In vitro cytotoxicity studies with gingival cells", Toxicology Letters, 91(3), pp.189~196 (1997)
- Bourrinet P, "Interlaboratory study for the assessment of potential irritative properties of hygiene products on the hamster cheek pouch", Lab Anim. Sci., 45(1), pp.36~40 (1995)
- European Union, "Council Directive on the approximation of the laws of the Member States relating to cosmetic products (76", 768, Official Journal of the European Union, pp.2003, 11(3)[DOI]
- European Union, "Regulation (EC) No 1223", 2009 of the European parliament and of the council on cosmetic products, 2009
- Herlofson BB, "Oral mucosal desquamation caused by two toothpaste detergents in an experimental model", Eur J Oral Sci, 104, pp.21~26 (1996)
- ISO, "ISO 10993-5:2009(E). Biological evaluation of medical device Part 5 test for in vitro cytotoxicity: Agar diffusion assay", ~ (2009)
- ISO, "ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization", ~ (2010)
- Rantanen, "The effects of two sodium lauryl sulphate-containing toothpastes with and without betaine on human oral mucosa in vivo", Swedish Denal Journal, 27, pp.31~24 (2003)
- US, "United States pharmacopeia 31. General chapter 87, biological reactivity test, in vitro", ~ (2015)
- Veys RJ, "Histological changes in the hamster cheek pounch epithelium induced by topical application of sodium lauryl sulphate", Int. J.Path., 75, pp.203~209 (1994)