It is recommended that an evaluation of the impact of shipping of Reconstructed human Epidermis (RhE) tissues be conducted especially after long-haul airfreight shipments. The OECD Test Guideline 439 (OECD TG 439), In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, recommends that users do so...
The selection of reference and proficiency chemicals is an important component of method validation and proficiency evaluations. Reference chemicals are a set of test substances used by a method developer to evaluate there liability and relevance of a new method, in comparison to reference data...
Next generation tobacco and nicotine products (NGPs) such as electronic cigarettes (EC) and tobacco heating products (THP) have reduced toxicity and hold great potential for reducing the risks associated with cigarette smoking. NGPs may also have hygiene benefits for consumers that switch to these products....
FDA’s recently launched Predictive Toxicology Roadmap calls for the optimization of non-animal methods for the safety evaluation of drugs, consumer products and medical devices. We have created an Industry Consortium comprised of manufacturers of personal lubricants/vaginal moisturizers and companies interested in the advancement of animal...
Currently China is striving to adopt and implement non-animal, including in vitro, testing approaches for the safety assessment of cosmetics and ingredients. Collaborative efforts between industry and the Institute for In Vitro Sciences (IIVS, Gaithersburg, USA) have focused on the transfer of several OECD Test Guideline...
To address ocular device induced phototoxicity, an in vitro 3T3 Neutral Red Uptake Phototoxicity test (OECD 432) for chemicals has been modified. Soft contact lenses formulated with three different photo-absorbing compounds and chemical solutions of these compounds were evaluated....
Alternative methods, including the validated 3T3 Neutral Red Uptake (NRU) Phototoxicity assay (OECD TG 432) may be used as a pre-clinical test to address phototoxicity. Currently, there are no validated alternative test methods to identify photoallergens; however, there are several validated alternative test methods to...
Robust non-animal models and assays for pulmonary toxicology are required to make competent product development and risk assessments for new materials requiring toxicity testing. Three in vitro assays (goblet cell hyperplasia [GCH], ciliary beat frequency [CBF], and MUC5AC quantitation) were evaluated for performance and reproducibility....
E-vapor product liquids contain a variety of ingredient combinations that should be assessed for human risk. One human lung-relevant testing platform with reasonable throughput, is human precision-cut lung slices (HuPCLS). HuPCLS are arguably the most complex non-animal model of the lung, retaining native architecture and...
While data are still being collected and analyzed, there were at least 1,300 accidental electronic liquid (e-liquid) exposures reported as of 2013. Deaths have occurred as a result of ingestion of e-liquid with the effects being attributed primarily to nicotine. The Food and Drug Administration (FDA)...