Skin Irritation Test (SIT) according to OECD TG 439
using 3D reconstructed tissue model of human epidermis
The workshop will provide an overview of the use of in vitro 3D reconstructed skin tissue model EpiDerm in toxicology and pharmacology as well as the practical demonstration of EpiDerm skin irritation test according to OECD TG 439. Participants will learn about implementation of 3D reconstructed human skin tissue model EpiDerm into the safety assessment of cosmetics, chemicals, drugs and medical devices. Validation and implementation of this novel technology into the regulatory toxicology and use in the testing strategies will also be discussed.
EpiDerm 3D human tissue model is used across a diverse range of applications including safety and risk assessment, and biological efficacy. Simple protocols and the evaluation of early cellular endpoints allow research to acquire data in few days. EpiDerm, a Reconstructed Human Epidermis (RHE) model, is a ready-to-use, highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK) cultured on specially prepared tissue culture inserts Cultured at the air-liquid interface (ALI), EpiDerm allows for the evaluation of topically applied compounds, chemicals, cosmetic/personal care product ingredients and final formulations. With multiple ECVAM validations and OECD accepted test guidelines, EpiDerm is a proven in vitro model system for chemical, pharmaceutical and skin care product testing. EpiDerm skin irritation test (SIT) is validated and accepted as OECD TG 439, EpiDerm skin corrosion test (SCT) is validated and accepted as OECD TG 431, EpiDerm skin irritation test for medical device extracts is validated and accepted as ISO 10993:23 and EpiDerm phototoxicity test is accepted by ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) as a useful component of the testing strategy for pre-clinical testing of topically applied pharmaceuticals, in ICH guideline S10 (ICH S10 Photosafety Evaluation of Pharmaceuticals) and fulfills the requirements of OECD test guideline, TG 498 adopted in June 2021.
1. Overview of regulatory accepted methods for skin topical toxicity testing using EpiDerm tissue model.
2. Introduction to SOP for EpiDerm SIT according to OECD TG 439.
3. Hands-on training on EpiDerm SIT according to OECD TG 439.
This workshop is limited to 30 participants. No registration fee required.
Registration for the workshop will open soon for registered participants only!