Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | NewsType Posters & Presentations
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Posters & Presentations

Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

E. Hill, R. Curren, and G.-E. Costin Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach to substitute for the RVI. Our Validation Program will analyze paired in vivo-in vitro data for vaginal irritation utilizing commercially available human reconstructed vaginal tissue models. A Prediction Model will be proposed that can be used for the safety assessment of personal lubricants. Our Validation Program proposal has been accepted in the Incubator Phase of the US FDA Medical Device Development Tool (MDDT) Pilot Program and is currently ongoing.

Using In Vitro Assays, the Direct Peptide Reactivity Assay (DPRA), KeratinoSens™ Assay (KS), and Human Cell Line Activation Test (h-CLAT) to Assess Skin Sensitization Potential of Electronic Cigarette Liquids

April 4, 2017

Three regulatory accepted in vitro assays were evaluated in a proof-of-concept project to determine skin sensitization potential of electronic cigarette liquids (eliquids). These assays measure molecular initiating events and initial cellular responses prescribed in the OECD Integrated Testing Strategy (ITS) describing key events in the adverse outcome pathway (AOP) leading to skin sensitization.

Precision Digital Dispensing of Patterned Picoliter Quantities of Test Material onto Apical Surfaces of Human 3D-Reconstructed Airway Tissues

March 30, 2017

There is an increasing need for researchers to understand the dynamic aspects of inhaled tobacco product exposure. Available 3D human reconstructed airway tissues (RHuA) provide researchers with a more physiological platform that offers apical and basal compartments for flexibility in modelling relevant exposures. We have tested the Tecan D300 digital dispenser as potential technical solution to deliver precise amounts of very small vehicle droplets to coat the apical surface of an available RHuA.

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

Evaluation of the Validated In Vitro Skin Irritation Test (OECD TG 439) for the Assignment of EPA Hazard Categories

April 1, 2016

Progress within the in vitro toxicology field has made available testing platforms based on reconstructed tissue models that are validated to address the skin corrosion and irritation endpoints. While the validated in vitro assays can be used for the hazard identification of chemicals irritant to skin in accordance with the United Nations (UN) Globally Harmonized System (GHS) for Classification and Labeling of Chemicals, they were not calibrated to address the classification system used by the United States Environmental Protection Agency (US EPA).