IIVS, Non Animal Testing, Alternative Test Methods, In Vitro Toxicology | Assays KeratinoSens
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Archive

Webinar: How GLPs Enhance the Quality of Regulated and Non-Regulated Toxicology

October 18, 2016
This 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...

LuSens (OECD 442D)

August 24, 2016
Similar to the KeratinoSens assay (OECD 442D), also offered by IIVS, LuSens addresses the cellular event of Keratinocyte activation, the second key event that triggers the induction of skin sensitization.  It is a luciferase-assay bioassay performed in a human keratinocyte cell line.  The approach is based on evaluating the upregulation of a gene involved in the induction of the sensitization response. IIVS participated in an inter-laboratory study led by BASF to assess the transferability, reproducibility, and accuracy of the method.  The...

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...

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 &...

KeratinoSens (OECD 442D)

August 24, 2016
The KeratinoSensTM assay is a cell-based reporter gene assay that models the second key event in the Adverse Outcome Pathway for Dermal Sensitization, namely keratinocyte activation.  This approach measures the induction of luciferase under the control of the antioxidant response element (ARE) derived from the human AKR1C2 gene, and can be used in a Weight of Evidence approach as an alternative to animal testing methods for the purpose of hazard identification. IIVS has participated in validation studies led by the assay developer...

Next Generation Tobacco Products

August 24, 2016
IIVS 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...

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...

Pharmaceutical

August 16, 2016
Pharmaceutical companies can use in vitro testing for assessing worker safety. Pharmaceutical intermediates should be evaluated to determine the primary hazards associated with them so that those involved in the manufacturing process can take necessary precautions to avoid hazardous exposures. Pharmaceutical compounds can vary widely in their physical forms, such as powders, liquids, and creams. Many in vitro assays such as those using 3-dimensional tissue constructs, and the Bovine Corneal Opacity and Permeability (BCOP) Assay, are suitable for testing different test...

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...