An in vitro human assay for evaluating immunogenic and sensitization potential of a personal care and cosmetic product

Abstract

With the reduction or elimination of animal testing, manufacturers are left with limited options, as few robust in vitro tests are available and human studies are costly. Recently, concerns have been raised regarding potential adverse health effects associated with use of WEN by Chaz Dean (WCD) cleansing conditioners. The purpose of this study was to evaluate the immunogenic potential of a WCD hair cleansing conditioner by utilizing a novel in vitro human skin explant test. Peripheral blood mononuclear cells (PBMCs) and human skin biopsies were obtained from healthy volunteers. Monocyte derived dendritic cells (MoDCs) were generated, primed by 0.01% WCD cleansing conditioner exposure for 24 h, co-cultured with autologous lymphocytes for 4 days, and then cultured with skin biopsies for 3 days. The skin biopsies then underwent histopathological evaluation, and T cell proliferation and IFNγ levels were determined. Overall, this study showed that treatment with 0.01% WCD cleansing conditioner resulted in a negative prediction for in vivo immune response. Further, this analysis shows that the skin explant test is a viable alternative to animal testing for complex mixtures or commercially available products.

Keywords:

• Immunogenic
• sensitization
• cosmetic
• personal care product
• in vitro testing

Disclosure statement

The author(s) declared potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Authors ADM, KMT, and ESF are or were employed by Cardno Chem-Risk, a consulting firm that provides scientific advice to the government, corporations, law firms and various scientific/professional organizations. Cardno ChemRisk has been engaged by WEN by Chaz Dean, Inc. (WCD), which produces personal care products, including the product examined in this study. This article was prepared and written exclusively by the authors without review or comment by any outside entity. It is possible that this work will be relied upon in litigation.