Archive
Human Cell Line Activation Test (h-CLAT, OECD 442E)
August 24, 2016The human Cell Line Activation Test (h-CLAT) is a cell-based assay that identifies skin sensitizers by examining changes in the expression of cell surface markers (CD54 and CD86) implicated in dendritic cell activation, the third key event of the skin sensitization AOP. Following exposure of the THP-1 human monocyte cell line to the test substance, expression levels of CD54 and CD86 are quantified by flow cytometry and compared to controls. The method has been reviewed by the European Union Reference Laboratory for...
Inflammatory Cytokine Expression
August 24, 2016Many manufacturers of personal care and cosmetic products expect (along with their customers) that their products will not irritate the skin. Unfortunately, many ingredients (e.g. surfactants, preservatives, emulsifiers and many other organic substances) have an inherent irritating property. Although other in vitro assays can predict irritancy vs. non-irritancy for purposes of regulatory compliance, many of these manufacturers need to differentiate between moderately irritating substances and those which are much milder. Some examples are: baby products, moisturizers or other products used...
Dermal Irritation Time to Toxicity
August 24, 2016Product development/product stewardship scientists and formulators typically find it desirable to compare or rank order the skin irritation potential of candidate formulations, or to monitor the impact of changes in formulations or ingredients on skin tolerance. Foremost, industry researchers need timely, accurate, cost-effective test results to help them get safer products to the marketplace. The Dermal Irritation Screening assay using a Time-to-Toxicity (ET50) protocol coupled with IIVS’ expertise in the methods help researchers meet their testing goals. The assay is designed...
Skin Irritation Test (SIT, OECD 439)
August 24, 2016Skin Irritation Test (SIT) in a Reconstructed Human Epidermis (RhE) Model Skin Irritation in the regulatory hazard classification and labeling context is defined as the production of reversible damage to skin following a defined chemical exposure. The Skin Irritation Test (SIT) is an in vitro, non-animal test designed to identify those chemicals and mixtures capable of inducing moderate skin irritation (UN GHS Category 2 Skin Irritants1), and to discriminate UN GHS Category 2 Skin Irritants from UN GHS 3 Mild Skin...
Next Generation Tobacco Products
August 24, 2016IIVS has a long-standing history of working with various industries to help establish or utilize in vitro models for the prediction of risk and the assessment of products under development. With the Food and Drug Administration extending its authority to all tobacco products (including e-cigarettes, cigars, and hookah) the tobacco industry is faced with the task of assessing product safety for product development and regulatory submission. Further, the manufacture of tobacco products may entail risk to workers that come in...
Specialty Chemical
August 24, 2016Specialty chemicals are chemical products identified on the basis of their performance or function, rather than their composition. They can be single-chemical entities or formulations and cover a wide range of product categories such as consumer products, cosmetics, food additives, manufacturing, etc. As a result, testing for these chemicals can include a wide range in the irritation spectrum, from materials that are classified as mild irritants to those that are designated as corrosive. The testing needs also cover a wide range...
Cosmetics & Personal Care
August 24, 2016European legislation and US research activities towards ‘21st century toxicology’ are setting the standards for animal-free toxicological assessments and the cosmetics industry has been the first to feel the effects. As per EU Regulation 1223/2009, animal testing of cosmetic ingredients and finished products is currently banned in the EU, as is the marketing of finished cosmetic products and the ingredients contained therein which were tested on animals for cosmetic safety assessment purposes. These bans hold irrespective of the availability of validated...
Pigmentation & Melanogenesis
August 23, 2016The efficacy of ingredients or final formulations in modulating human skin pigmentation can be assessed in vitro by analysis of melanin production in reconstructed tissue models of various phototypes. In addition, this testing platform is suitable for investigation of the dermal irritation potential of test materials after repeated exposures using a tissue viability endpoint. The evaluation of the potential impact on melanin production of raw ingredients or finished products intended for the modulation of skin pigmentation can be assessed using pigmented...
Corrositex (OECD 435)
August 23, 2016The Corrositex® assay is a standardized and quantitative in vitro test developed as a replacement for the dermal corrosivity rabbit test. The Corrositex kit, manufactured by In Vitro International (IVI), uses a proprietary biobarrier membrane to model the skin for evaluating the potential dermal corrosivity of a test material. A test material is evaluated based on its penetration through the biobarrier membrane into a Chemical Detection System (CDS). The time required for the test material to break through the biobarrier and into the CDS is...