Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Assays ARE-Nrf2 Luciferase Keratinocyte Activation Test Method
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How the Good In Vitro Method Practices Guidance Document Can Help Implement New Toxicological Approaches: A Case Study in China

October 17, 2018
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 methods to government laboratories in China and have supported the creation of an in vitro toxicology testing laboratory within the Zhejiang Institute for Food and Drug Control (Hangzhou, China).  Recently BASF SE (Ludwigshafen, Germany) and IIVS...

Modernization of EPA “6-Pack” of Acute Toxicity Tests Continues

July 26, 2018
The US Environmental Protection Agency (US EPA) continues to drive significant efforts in the United States to modernize the battery of acute toxicity tests classically known as the “6-pack.” Known for many years as an “all in vivo” testing strategy for products registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the 6-pack was revised in 2015 to include non-animal (in vitro/ex vivo) test methods for classification and labeling for Eye Irritation, both for commonly used household cleaning products...

IIVS e-News – January 2018

February 1, 2018
Featured in this issue is an article on how an integrated approach to skin sensitization testing can work for your testing program. a preview of IIVS events and posters at SOT, our recent collaboration with BASF to distribute the LuSens test in China, and more.  Read issue....

IIVS and BASF Collaborate to Distribute Test Method to Replace Animal Testing in China

January 9, 2018
GAITHERSBURG, MD – January 9, 2018 – The Institute for In Vitro Sciences, Inc. (IIVS) today announced a collaboration with BASF to import a non-animal, cell based, safety test into China. The LuSens test, developed by BASF, is an in vitro test to detect the sensitization potential of chemicals to human skin. The test was developed to be license free and shared with the scientific community at-large. It has recently been incorporated into the Organization for Economic Co-operation and Development...

Human Cell Line Activation Test (h-CLAT, OECD 442E)

August 24, 2016
The 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...

Direct Peptide Reactivity Activation Assay (DPRA, OECD 442C)

August 24, 2016
The DPRA  (OECD 442C) is an in chemico assay that  models the first key event in the skin sensitization Adverse Outcome Pathway (AOP) - skin, protein reactivity. Compounds implicated in causing Allergic Contact Dermatitis (ACD) are generally electrophilic in nature. This assay identifies dermal sensitizers based on their reactivity with synthetic peptides containing the nucleophilic amino acid residues lysine and cysteine. Using LC/UV, conjugation of the test material with the peptides can be analyzed. Trained by the developers of this assay (Procter & Gamble), IIVS...

Fragrance & Flavors

August 24, 2016
Exposure to fragrance chemicals is most commonly by direct skin contact. Allergic contact dermatitis (ACD) to fragrance ingredients is most often caused by cosmetic products, such as perfumes, deodorants, and aftershave products. Cosmetic fragrance ingredients should be assessed for exposure damage including skin sensitization (ACD), phototoxicity, skin irritation (irritant contact dermatitis), and respiratory irritation and sensitization. At IIVS, we have pre-clinical testing programs to address each of these endpoints to ensure the safety of fragrance 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Cosmetics & Personal Care

August 24, 2016
European 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...

Occupational Safety & Industrial Hygiene

July 28, 2016
Employers are required to inform workers of the hazards of the chemicals or products that they are using. Many in vitro assays are suited to accomplish this goal. As Hazard Communication is now aligned with the Globally Harmonized System (GHS), assays that are approved for assigning GHS hazard categories can provide a method for properly labelling chemicals and preparing safety data sheets. Skin Corrosion assays (Reconstructed Human Epidermis (OECD TG 431) and Membrane Barrier Test (OECD TG 435)) can be used...