Dr. Dan Bagley joins the IIVS Board of Directors; President of IIVS Recognized with Award by PCRM; Award for IIVS Training on Alternative Methods IIVS Toxicologist Dr. Argel Islas-Robles participated last week as speaker on the “In Vitro Science Webinars Series” focusing on the topic of non-Animal Methods for dermal and ocular testing on personal care and cosmetics (presentation in Spanish). This was first in a series of events designed to highlight New Approach Methodologies (NAMs) for human and environmental safety without the use of animal experimentation in Latin America.
The ability to ascertain the maximum limit of a compound that can be applied to the skin without inducing skin sensitization is a critical safety criterion for virtually any risk assessment. Using regression models developed by Givaudan (Kempthal, Switzerland), IIVS is able to perform a computational approach to determine predicted EC3 values (Effective Concentration required to induce a 3-fold upregulation of lymph node cell proliferation) using a combination of OECD approved assays (KeratinoSens, hCLAT, and kDPRA). This value can be used to assess risk for compounds to be included in formulations.
NEW! Good In Vitro Method Practices (GIVMP) Certification IIVS is pleased to announce our new business-to-business GIVIMP Certification Program created to help laboratories: As an OECD guidance document, GIVIMP sets forth internationally recognized quality standards to help ensure that new in vitro methods are ready for implementation, and to foster confidence in the resulting data for use by industry or regulatory bodies.
In addition to IIVS’ non-animal safety testing services, we also provide efficacy testing designed to evaluate raw materials and formulations for anti-inflammatory and skin tone modulating properties. Inflammation is a common effect experienced after encounters with irritating substances, bacterial infection or by those suffering from auto-immune diseases.
It’s been a very exciting year in the field of New Approach Methodologies (NAMs) with the release of the OECD 497 and 498 Test Guidelines which have codified Defined Approaches for Skin Sensitization and the Reconstructed Human Epidermis Phototoxicity Test, respectively.
The Defined Approaches (DAs) to Skin Sensitization Test Guideline cites 2 strategies which can be used to evaluate hazard potential of compounds and 1 strategy to evaluate GHS potency. The hazard DAs involve in vitroapproaches to the evaluation of sensitization using multiple assays which evaluate different steps in the Adverse Outcome Pathway. Both the "2 out of 3" (Fig 1) and "Key Event 3/1" approaches (Fig 2) have been included in the OECD Test Guideline. The potency assessment is an extension of the Kao Integrated Testing Strategy and, in addition to the performance of the DPRA and h-CLAT assays, includes the additional step of QSAR analysis of the compound of interest. (Fig 3). This approach permits classification of sensitizers as strong (GHS 1A), weak (GHS 1B) or non-classified.
IIVS and the Research Institute for Fragrance Materials (RIFM) have initiated a collaboration to develop tests designed to assess potential respiratory allergens. Developing a reliable, in vitroassay to assess the allergenicity of materials to the airway tract has been an area of active research for well over a decade, however most efforts have resulted in poor accuracy and the inability to distinguish airway sensitizers from irritants. By combining the extensive expertise and knowledge base in the field of respiratory toxicology of both organizations, we are confident that an assay can be developed to robustly assess this endpoint.
IIVS is pleased to announce that Allison Hilberer will participate in the OECD Test Guidelines Programme Expert Groups (OECD TG EG) for eye and skin irritation, phototoxicity and skin sensitization. Allison is a Toxicologist II and Study Director at IIVS where she oversees the conduct of in vitrostudies in these areas. Allison has also been involved in many validation programs and participated in efforts to draft and revise OECD Test Guidelines. Read Post
In this issue, learn about our appointment to a working group in China for alternatives, our collaboration with BASF and Givaudan, our presence at estiv2018 and the PCPC 2018 Science Symposium, and more. Read issue.