Archive
European Partnership Supports IIVS Training of Chinese Scientists in Non-animal Tests
May 9, 2019Gaithersburg, MD – May 8, 2019 – The Institute for In Vitro Sciences, Inc. (IIVS) has received a grant from the European Partnership for Alternative Approaches to Animal Testing (EPAA) to support its annual training of Chinese scientists in non-animal testing methods. As part of the agreement, two scientists from BASF SE, a member of EPAA, will join IIVS to provide hands-on training in China for four non-animal approaches for skin sensitization. This training follows the recent announcement by China’s...
China’s Acceptance of Certain Non-Animal Testing Methods for the Regulation of Cosmetics
April 3, 2019Gaithersburg, MD – April 3, 2019 – The Institute for In Vitro Sciences (IIVS) applauds China’s National Medical Products Administration (NMPA) for their acceptance of certain non-animal (alternative) test methods for the regulation of cosmetics. In a notice issued on March 22, the NMPA drafted acceptance of nine test methods including: Direct Peptide Reaction Assay (DPRA) for Skin Sensitization (OECD TG 442C) Short Time Exposure Assay (STE) for eye irritation (OECD TG 491) These new regulations will go into effect January...
China’s NMPA Approves Two New In Vitro Methods For Regulating Cosmetics
March 22, 2019We are pleased to share that today China’s National Medical Products Association (NMPA) has approved new methods for the regulations of cosmetics. Among these are two in vitro methods: DPRA for skin sensitization and the Short Time Exposure (STE) assay for eye irritation. IIVS’ International Outreach Program introduced these methods during its training program with NMPA and we will continue to support their implementation in key laboratories....
ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D)
October 18, 2018KeratinoSensTM is a cell-based reporter gene assay that models the second key event in the Adverse Outcome Pathway for Dermal Sensitization (keratinocyte activation). The assay measures the induction of a stably transfected luciferase gene under the control of the antioxidant response element (ARE) derived from the human AKR1C2 gene. Following the methodology described in OECD Test Guideline 497, KeratinoSens is an alternative to animal testing methods necessary for the purpose of hazard identification. In conjunction with other in vitro tests, the results of this assay...
Modernization of EPA “6-Pack” of Acute Toxicity Tests Continues
July 27, 2018The 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.” Learn More....
The Assessment of Phototoxicity Using the 3T3 Neutral Red Uptake (NRU) Phototoxicity Assay and a Modified Photo-Direct Peptide Reactivity Assay (DPRA)
March 28, 2018Alternative 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 address skin sensitization, including the Direct Peptide Reactivity Assay (DPRA) (OECD 442C). To address photoallergy, we utilized the 3T3 Phototoxicity assay in combination with a modified photo-DPRA assay to determine if these assays were able...
IIVS e-News – January 2018
February 1, 2018Featured 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....
Webinar: How GLPs Enhance the Quality of Regulated and Non-Regulated Toxicology
October 18, 2016This one-hour webinar, led by IIVS Director of Quality and Compliance, introduces some of the concepts of Good Laboratory Practices (GLPs) designed to promote study and data integrity within an in vitro toxicology framework. Applying these concepts within your own laboratory should aid in production of robust, repeatable studies. View Slides...
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...
Direct Peptide Reactivity Assay (DPRA, OECD 442C)
August 24, 2016The 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...