Skin2®- an in vitro human skin model: the correlation between in vivo and in Vitro testing of surfactants

• Published in: Experimental dermatology 1998-02, Vol.7 (1), p.18-26
• Main Authors: Demetrulias, Janis, Donnelly, Tracy, Morhenn, Vera, Jessee, Bret, Hainsworth, Sharon, Casterton, Phil, Bernhofer, Lauren, Martin, Katharine, Decker, Denise
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Animal Testing Alternatives; Animals; Culture Techniques; cutaneous irritation; Dermatitis, Irritant - etiology; Drug Evaluation; Drug Evaluation, Preclinical - methods; Female; Humans; in vitro; Irritants - toxicity; Male; Middle Aged; Models, Biological; organotypic; Patch Tests; Skin - drug effects; skin2; Surface-Active Agents - toxicity; surfactant
• ISSN: 0906-6705; 1600-0625
• DOI: 10.1111/j.1600-0625.1998.tb00298.x

: The availability of an in vitro test system to replace animal testing of potential irritants is becoming more and more urgent especially in Europe as a consequence of the European Community Cosmetics Directive. To evaluate the ability of Advanced Tissue Sciences'(ATS) ZK1301 skin model to predict the skin irritation potential of surfactants, we performed a pilot validation study utilizing four different laboratories. The in vitro protocol was designed as a quantitative pre‐screen for the clinical patch studies. Sixteen substances, representing various surfactant categories and ranges of irritation potential, were tested. The 3‐[4,5‐Dimethylthiazol‐2‐yl]‐2,5‐diphenyltetrazolium bromide (MTT) assay was used to quantitate viability in vitro. we documented the viability of tissues exposed to unknown substances for specific periods. The in vtiro results were calcuslated as percent distilled water controls (DWC). The time required to reduce the viability of each tissue to 50% of the distilled water controls (T50) was compared to men erthema and edema scores from the clinical studies by Pearson's correlation. The individual laboratories demonstrated coefficients of 072. The results indicated that the 30 min percent untreated control values best predicted the 24 h clinical patch scores. No statistically significant interlab variability was found. Only one false negative was seen when non/mild and moderate/severe irritant categories were assigned according to the in vitro scores. These results demonstrate that the skin2®in vitro test system may serve as a good screening method prior to clinical patch studdies.