대한화장품학회지 (Journal of the Society of Cosmetic Scientists of Korea)
- 제17권1호
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- Pages.64-80
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- 1991
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- 1226-2587(pISSN)
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- 2288-9507(eISSN)
VALIDATION AND UTILIZATION OF THE SKINTEXTM SYSTEM
- Gordon, V.C. (ROPAK Laboratories) ;
- Realica, B. (ROPAK Laboratories) ;
- Tolstrup, K. (ROPAK Laboratories) ;
- Puls, B. (ROPAK Laboratories)
- 발행 : 1991.10.01
초록
The SKINTEX Method is based on a two-compartment physico-chemical model which includes a Biomembrane Barrier in compartment one and an organized macromolecular matrix in compartment two. Test samples absorb onto or permeate through the keratin/collagen Biomembrane Barrier and then can interact with the organized macromolecular matrix. Changes in the integrity of the barrier release a dye indicator: Changes in the matrix can alter its transparency. The sum of these two responses is read spectrophotometrically at 470nm. An early investigation of 950 chemicals and formulations in the SKINTEX System produced results which were 89% concordance to in vivo Draize dermal irritation results obtained with 24-hour occluded application of test samples with-out abrasion and standard scoring. Alkaline materials were analyzed in a specialized SKINTEX AMA Protocol. In this early study, the model did not distinguish nonirritant test materials and formulation with PDII(Primary Dermal Irritation Index)in the range from 0 to 1.2, A High Sensitivity Assay Protocol(HSA)was developed to amplify the changes in both compartments of this model and provide more accurate calibration of these changes. A study of 60 low irritation test samples including cosmetics, household products, chemicals and petro-chemicals distinguished nonirritants with PDII
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