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Implementation of the first stand-alone NAMs for eye hazard identification into OECD Guidelines: OECD GL 467 and TG 492B.
In the past decade, a number of Non-Animal Methods (NAMs) for predicting eye hazards of chemicals have been adopted as OECD Test Guidelines. However, to this date, no single NAM could completely replace the in vivo Draize eye test method due to the difficulty with predicting the middle category (i.e., eye irritation) for eye hazards. Studies have shown that this difficulty is linked to the variability and inconsistency within the results from the Draize eye test, which is used as reference data for evaluating the predictive capacity of the NAMs for eye hazard identification.

The newly adopted OECD GL 467 on Defined Approaches addresses this challenge and is the first stand-alone NAM based OECD Guideline. Defined approaches in OECD GL 467 use multiple information sources according to a fixed Data Interpretation Procedure (DIP) and allow for prediction of all eye hazard categories. OECD also recently adopted TG 492B, another stand-alone NAM based OECD Guideline.

OECD prepared this webinar to increase the awareness of these newly adopted guidelines for regulatory acceptance and to recognize the efforts of the organization as well as its stakeholders to enable 3R Principles for chemical hazard testing.

This webinar will be consisted of three parts on: 1) Draize eye test Reference Database (DRD), 2) OECD Guideline 467 on Defined Approaches for Serious Eye Damage and Eye Irritation and 3) OECD Test Guideline 492B on Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification.

Sep 27, 2022 02:00 PM in Paris

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João Barroso
Scientific Officer @European Commission Joint Research Centre
João holds a PhD in Biochemistry since 2005. He joined the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the European Commission’s Joint Research Centre (JRC) in 2008. At EURL ECVAM, he coordinates and conducts scientific and policy support activities in the area of non-animal methods, including the identification, assessment and validation of promising methodologies for regulatory and biomedical applications and their translation in to EU legislation and international standards (e.g., OECD Test Guidelines, UN GHS). João also coordinates the ESAC, a scientific advisory committee responsible for conducting independent scientific reviews on non-animal methods and approaches on request of EURL ECVAM, as well as the issuing of EURL ECVAM Recommendations on the basis of ESAC Opinions. João is the vice-president of the European Society of Toxicology In Vitro (ESTIV).
Els Adriaens
Consultant statistical data analysis @CEO Adriaens Consulting BVBA
Dr. Els Adriaens studied biology, obtained a PhD at the Faculty of Pharmaceutical Sciences and subsequently a master’s degree in statistical data analysis. She has been a consultant since 2008 in statistical data analysis specialized in the field of the development and validation of alternatives to laboratory animals (domain: in vitro alternatives to eye and skin irritation, sensitization, genotoxicity). She is also a consultant for several health care companies in the preclinical as well as in the clinical department (medical devices, nutritional supplements). She also teaches statistics courses since 2012 at the academy of lifelong learning of the Faculty of Sciences at Ghent University.
Nathalie Alépée
Scientific Officer @L’Oréal
Dr. Alépée has passionately dedicated her career to the replacement of animal testing with scientifically advanced animal-free approaches. She has worked at L’Oréal since 2008 and is responsible for scientific leadership with respect to current and future requirement in safety endpoints on local tolerance endpoints e.g., skin & eye irritation, skin sensitisation and phototoxicity. A large part of her job focuses on L’Oréal’s ongoing effort to develop and integrate new approach methodologies for hazard and risk assessment and get their validation and regulatory implementation. She currently represents L’Oréal in scientific committees of the Cosmetics Association, the European Partnership for Alternative Approaches to Animal Testing (EPAA) and AFSA, as well as France on OECD activities. She particularly enjoys taking into account and integrating diversity of opinions, multidisciplinary approaches and networking to reach scientific-driven goals that support international harmonisation.