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Validation

1096

Using a reconstructed human vaginal epithelium model to assess irritation: A proof-of-concept study supporting regulatory qualification of the method for use with personal lubricants

Consumers tend to think of personal lubricants as personal care products or cosmetics that are not tested using animals, but the regulatory classification and hence the testing requirements for these products vary by country. For example, in the United States, regulations and guidance classify personal lubricants as medical devices, for which manufacturers must perform a […]
1046

Vaginal irritation testing—prospects of human organotypic vaginal tissue culture models

Personal lubricants intended for local or systemic delivery via the vaginal route can induce vaginal irritation, damage the vaginal epithelial barrier which can enhance microbial entry, induce infammation, and alter the microbiome of the vaginal ecosystem. Therefore, manufacturers of personal lubricants and medical devices are required to show biocompatibility and safety assessment data to support […]
936

Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts

Assessment of skin irritation is an essential component of the safety evaluation of medical devices. OECD Test Guideline 439 describes the use of reconstructed human epidermis (RhE) as an in vitro test system for classification of skin irritation by neat chemicals. An international round robin study was conducted to evaluate the RhE method for determination […]
926

Retrospective review on in vitro phototoxicity data generated in 3D skin models to support the development of new OECD Test Guideline

Phototoxicity (also photo-irritation), is a light-induced skin reaction that occurs when photoreactive chemicals are activated to produce cytotoxic effects. Phototoxicity testing of chemicals is mostly conducted in vitro, following the methods described in the OECD test guideline (OECD TG 432), using the Balb/c 3T3 mouse fibroblast cell line. The test is highly sensitive, but low […]