Documents & Resources

Addressing the Assignment of US EPA Hazard Categories for Dermal Safety by a Revised Prediction Model of the Validated In Vitro Skin Irritation Test (OECD TG 439)

March 30, 2017

One of the current goals of the United States Environmental Protection Agency Office of Pesticide Programs (US EPA OPP) is to replace by non-animal testing methods as many of the endpoints of the battery of acute toxicity tests known as the “6-pack” as possible. One of the “6-pack” tests is the Draize rabbit test for dermal irritation. We investigated whether the validated in vitro Skin Irritation Test (SIT, OECD TG 439) can be used to determine US EPA OPP dermal hazard category assignment.

The 3D Human Reconstructed Skin Micronucleus Assay (RSMN) Using the EpiDerm Tissue: Validation and Application to the Safety Assessment of Cosmetics Ingredients

March 30, 2017

Regulatory restrictions on animal use have increased the reliance of risk assessors and regulators on in vitro test systems. Ideally, tissue-based assays could replace the animal studies as follow-up tools to verify results from standard in vitro assays. The RSMN assay combines the EpiDerm™ 3D reconstructed skin (RS) model with the micronucleus (MN) assay to provide a more realistic model for evaluating the genotoxic potential of dermally applied chemicals or products, such as cosmetics.

In Vitro Models Available for Testing of ENDS

February 20, 2017

Presented at the National Academies of Sciences, Engineering, and Medicine's (NAS) workshop on electronic nicotine delivery systems (ENDS), e-cigarettes.

Case Study: Applying GLPs to New, Non-Animal Methodologies

January 26, 2017

Presented at the 2nd Good Laboratory Practice Compliance Summit, January 26-27, 2017, Arlington, VA

In Vitro Assessment of Skin Irritation Potential of Surfactant-based Formulations by Using a 3-D Skin Reconstructed Tissue Model and Cytokine Response

January 24, 2017

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. Full article available to full and paid subscribers of ATLA.

The Use of Human 3D Reconstructed Airway Cultures for Tobacco Product Evaluation: Precision Low-Volume Exposures at the Apical Site

January 10, 2017

With a mandate to evaluate the dynamics of pulmonary exposure to inhaled materials such as tobacco-based products, researchers are employing complex, human, three-dimensional pulmonary models. Human reconstructed airway (RHuA) tissues present a platform that more closely resembles airways in vivo. Grown at the air–liquid interface (ALI), RHuA tissues offer apical and basal compartments that allow flexibility in modeling physiologically relevant exposures and provide sampling location-specific results. Read the full article.

Trends in Regenerative Medicine: Repigmentation in Vitiligo Through Melanocyte Stem Cell Mobilization

December 28, 2016

Vitiligo is the most frequent human pigmentary disorder, characterized by progressive autoimmune destruction of mature epidermal melanocytes. Of the current treatments offering partial and temporary relief, ultraviolet (UV) light is the most effective, coordinating an intricate network of keratinocyte and melanocyte factors that control numerous cellular and molecular signaling pathways. Read the full article.

Decoding and Modulating the Color of Human Skin

November 22, 2016

The constitutive color of human skin varies widely across the globe, from the very pale as in Celtic skin to the very dark present in regions such as sub-Saharan Africa. There is a biologic player “hard at work” producing the pigments that generate great variations in human skin color and is the protagonist of this article. It is the melanocyte. Read the full article.  

Video: The 3T3 Neutral Red Uptake Phototoxicity Test — Chinese

November 21, 2016

This training video with Chinese subtitles explores a cell-based method for assessing Phototoxicity — or the potential for chemicals to cause damage after being exposed to light. The method is used widely around the world by many industries, including the cosmetics and pharmaceutical sectors. Disclaimer: Please note that the procedures shown in this video were ...

Video: The 3T3 Neutral Red Uptake Phototoxicity Test — Portuguese

November 21, 2016

This new training video with Portuguese subtitles explores a cell-based method for assessing Phototoxicity — or the potential for chemicals to cause damage after being exposed to light. The method is used widely around the world by many industries, including the cosmetics and pharmaceutical sectors. Disclaimer: Please note that the procedures shown in this video were for ...