title: In vitro assessment of skin irritation potential of surfactant-based formulations by using a 3-D skin reconstructed tissue model and cytokine response.
abstract: The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release as a way to evaluate the potential dermal irritation of 224 non-ionic, amphoteric and/or anionic surfactant-containing formulations, or individual raw materials. As part of our testing programme, two representative benchmark materials with known clinical skin irritation potential were qualified through repeated testing, for use as references for the skin irritation evaluation of formulations containing new surfactant ingredients. We have established a correlation between the in vitro screening approach and clinical testing, and are continually expanding our database to enhance this correlation. This testing programme integrates the efforts of global manufacturers of personal care products that focus on the development of increasingly milder formulations to be applied to the skin, without the use of animal testing.
authors.affiliation: Johnson & Johnson Consumer Inc., Skillman, NJ, USA.
authors.forename: Russel M
authors.initials: RM
authors.lastname: Walters
authors.affiliation: Clariant Corporation, Charlotte, NC, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Gandolfi
authors.affiliation: Johnson & Johnson Consumer Inc., Skillman, NJ, USA.
authors.forename: M Catherine
authors.initials: MC
authors.lastname: Mack
authors.affiliation: Johnson & Johnson Consumer Inc., Skillman, NJ, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Fevola
authors.affiliation: Johnson & Johnson Consumer Inc., Skillman, NJ, USA.
authors.forename: Katharine
authors.initials: K
authors.lastname: Martin
authors.affiliation: Wellspring Worldwide Inc., Chicago, IL, USA.
authors.forename: Mathew T
authors.initials: MT
authors.lastname: Hamilton
authors.affiliation: Institute for In Vitro Sciences Inc., Gaithersburg, MD, USA.
authors.forename: Allison
authors.initials: A
authors.lastname: Hilberer
authors.affiliation: Institute for In Vitro Sciences Inc., Gaithersburg, MD, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Barnes
authors.affiliation: Institute for In Vitro Sciences Inc., Gaithersburg, MD, USA.
authors.forename: Nathan
authors.initials: N
authors.lastname: Wilt
authors.affiliation: Institute for In Vitro Sciences Inc., Gaithersburg, MD, USA.
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Nash
authors.affiliation: Institute for In Vitro Sciences Inc., Gaithersburg, MD, USA.
authors.forename: Hans A
authors.initials: HA
authors.lastname: Raabe
authors.affiliation: Institute for In Vitro Sciences Inc., Gaithersburg, MD, USA.
authors.forename: Gertrude-Emilia
authors.initials: GE
authors.lastname: Costin
mesh_terms: D023401:Animal Use Alternatives; D003358:Cosmetics / Q000633:toxicity*; D006801:Humans; D053582:Interleukin-1alpha / Q000032:analysis*; D017592:Skin Care; D023422:Skin Irritancy Tests; D013501:Surface-Active Agents / Q000633:toxicity*
chemical_list: D003358:Cosmetics; D053582:Interleukin-1alpha; D013501:Surface-Active Agents