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The PETA International Science Consortium and Chemical Watch, a leading global regulatory news and information service for the chemical industry, have teamed up again to present a free webinar series focusing on non-animal methods and testing strategies that can be used to meet REACH requirements. This updates the Lush Prize–winning 2014–2015 webinar series (archived below) and reflects the significant scientific and regulatory progress in the use and acceptance of non-animal methods that has occurred in recent years.
The webinars, available below, will be of interest to industry toxicologists, those registering chemicals for the first time, companies that would like to know more about the validated non-animal tests that are available and the ways other businesses are using them, and REACH consultants.
| Perspectives on the Development, Evaluation, and Application of in Silico Approaches for Predicting Toxicity 9 January 2018 Speakers: Dr Grace Patlewicz, US EPA Prof Mark Cronin, Liverpool John Moores University Click here for the pre-recorded webinar Click here for a full set of presentation slides |
Dr Patlewicz and Professor Cronin discuss the QSARs that can be used to meet regulatory testing requirements under REACH. The use of read-across is presented – emphasising both the availability of different frameworks for the development of read-across and frameworks for the assessment and evaluation of read-across justification – highlighting examples published in the literature as well as regulatory technical guidance (OECD, ECHA). Tools that can help facilitate the development of read-across, including the OECD QSAR Toolbox, are outlined. Attention is drawn to ongoing research that is evolving the way in which read-across approaches can be undertaken, including by exploiting the use of high-throughput screening data such as those generated under the US EPA’s ToxCast programme. The use of read-across and QSARs is framed in the context of integrated approaches to testing and assessment (IATA). Examples highlight how some IATA have evolved, particularly in the arena of skin sensitisation, where defined approaches have been developed. These formalise the use of certain non-animal test methods that characterise the key events within the associated adverse outcome pathway. |
| Skin Irritation and Corrosion 25 January 2018 Speakers: Dr Gertrude-Emilia Costin, Institute for In Vitro Sciences Dr Costanza Rovida, TEAM Mastery and CAAT-Europe Click here for a video recording Click here for a full set of presentation slides Click here for a copy of the Q&A from the session |
Dr Costin describes the in vitro methods that can be used to meet REACH data requirements for skin irritation and corrosion under Annexes VII and VIII. Dr Rovida uses specific examples to explain how the in vitro methods can be used in an integrated approach to testing and assessment. |
| Skin Sensitisation 1 February 2018 Speakers: Dr Susanne Kolle, BASF SE Dr Silvia Casati, EURL ECVAM Click here for a video recording Click here for a full set of presentation slides |
First, Dr Kolle introduces data requirements, including the 2016 update to REACH Annex VII, and provides an overview of the key mechanism of skin sensitisation, based on the published adverse outcome pathway. Dr Casati describes the in vitro and in chemico methods that can be used to assess skin sensitisation, with a specific focus on the validated and OECD-adopted methods and on combining them in defined approaches. Dr Kolle provides examples of defined approaches to hazard identification and potency categorisation. Dr Casati closes by reviewing current OECD activities in the field of skin sensitisation. |
| Serious Eye Damage and Eye Irritation 15 February 2018 Speakers: Dr Kim Norman, Burt’s Bees Dr Els Adriaens, Adriaens Consulting BVBA Click here for a video recording Click here for a full set of presentation slides |
Drs Norman and Adriaens first discuss the drivers of in vivo classification for serious eye damage and eye irritation in order to specify the requirements for achieving full replacement of the regulatory animal test. Then they describe the available in vitro methods and the ways in which they can be used alone or in combination in various testing strategies, such as top-down or bottom-up approaches. |
| 3R Approach to Acute Oral toxicity 19 December 2017 Speaker: Dr Kimmo Louekari, ECHA Click here for the pre-recorded webinar |
Dr Louekari presents on 3R approaches to acute oral toxicity testing. He describes an approach that includes waiving such testing when subacute oral toxicity data indicate low toxicity and an enhanced dose-range finding study, or in vitro 3T3 neutral red uptake cytotoxicity test, are provided in the context of the weight-of-evidence approach. |
Archive (2014-2015 webinar series)
| Webinar 1: OECD QSAR Toolbox and Read-Across 22 October 2014 Speakers: Dr Grace Patlewicz, DuPont Prof Mark Cronin, Liverpool John Moores University Click here for a video recording Click here for a full set of presentation slides Click here for a copy of the Q&A from the session |
Drs Cronin and Patlewicz briefly discuss the use of integrated approaches to testing and assessment and adverse outcome pathways to organize existing information and plan a non-animal testing strategy. Specifically, they discuss how QSARs and read-across can be used to meet REACH requirements and detail the use of the OECD QSAR Toolbox. There is also a discussion of future research projects. |
| Webinar 2: Skin Irritation and Corrosion 11 November 2014 Speakers: Dr Gertrude-Emilia Costin, Institute for In Vitro Sciences Dr Costanza Rovida, REACH Mastery and CAAT Europe Click here for a video recording Click here for a full set of presentation slides Click here for a copy of the Q&A from the session |
Dr Costin describes the in vitro methods that can be used to meet REACH data requirements for skin irritation and corrosion under Annexes VII and VIII. Dr Rovida explains how the in vitro methods can be used in an integrated approach to testing and assessment using specific examples. |
| Webinar 3: Serious Eye Damage and Eye Irritation 4 December 2014 Speakers: Dr Kim Norman, Institute for In Vitro Sciences Dr João Barroso, EURL ECVAM Click here for a video recording Click here for a full set of presentation slides |
Drs Norman and Barroso first discuss the drivers of in vivo classification for serious eye damage and eye irritation in order to define what is required to achieve full replacement of the regulatory animal test. Then, the available in vitro methods and how they can be used alone or in combination in testing strategies such as the top-down or bottom-up approaches, are described. |
| Webinar 4: Skin Sensitisation 28 January 2015 Speakers: Dr Susanne Kolle, BASF SE Dr Silvia Casati, EURL ECVAM Click here for a video recording Click here for a full set of presentation slides |
Dr Kolle first discusses data requirements and in vivo classification for skin sensitisation in order to define what is required to replace the animal test. Dr Casati provides an overview of the key mechanism of skin sensitization, based on the published adverse outcome pathway, and describes the in vitro and in chemico methods that can be used to assess skin sensitisation with a specific focus on the validated methods. Dr Kolle then discusses examples of how these methods can be combined in testing strategies / integrated approaches. She also presents how each method (or their combination) perform for “real life” substances, as well as specific case studies for read-across approaches, and how the methods can be applied for REACH. Dr Casati closes by reviewing current OECD activities in the field of skin sensitisation. |
| Webinar 5: Alternative Approaches to Mammalian Acute Systemic Toxicity Testing 5 March 2015 Speakers: Dr Pilar Prieto, EURL ECVAM Dr Lawrence Milchak, 3M Click here for a video recording Click here for a full set of presentation slides |
Dr Pilar Prieto presents on EURL ECVAM’s recently released strategy to replace, reduce, and refine the use of animals in the assessment of acute mammalian systemic toxicity. The strategy highlights the importance of developing adverse outcome pathways (AOPs) and integrated approaches to testing and assessment (IATA) related to acute systemic toxicity. It also discusses improvements in the predictability of the 3T3 NRU assay, development of additional in vitro and in silico approaches, waiving acute toxicity testing based on e.g., repeated dose data, refinement of in vivo studies, and a framework for prioritizing the alternative methods that have been submitted to EURL ECVAM for validation. Following Dr Prieto’s talk, Dr Lawrence Milchak from 3M speaks to industry experiences on the use of alternative strategies to meet acute toxicity testing requirements. |
| Webinar 6: (Zebra)fish Embryo Acute Toxicity Testing to Predict Short Term Toxicity to Fish (and Beyond) 14 April 2015 Speakers: Dr Marlies Halder, EURL ECVAM Prof Thomas Braunbeck, University of Heidelberg Dr Scott Belanger, Procter & Gamble Click here for a video recording Click here for a full set of presentation slides |
Dr Halder begins by describing the REACH data requirements for short term toxicity testing on fish and the OECD acute fish toxicity test (OECD TG 203). She then describes the Fish Embryo Acute Toxicity Test (FET), which was adopted by the OECD in 2013 as Test Guideline 236 and is recommended by the European Union Reference Laboratory for Alternatives to Animal Testing as a possible alternative to the acute fish toxicity test. Dr Belanger provides an assessment of the correlation between the OECD acute fish toxicity test and the fish embryo toxicity test. This includes an assessment of the domain of applicability and the possibility of using the FET in traditional fish Quantitative Structure Activity Relationships. Professor Braunbeck then describes the potential use of fish embryos beyond acute fish toxicity testing and provides a view to potential future uses of fish embryos in a much wider array of environmental science and human health applications. |
| Webinar 7: The Regulatory Processes Involved in Acceptance of Non-Animal Tests 10 June 2015 Speakers: Dr Derek Knight, ECHA Ms Karin Kilian, European Commission Click here for a video recording Click here for a full set of presentation slides |
Dr Knight, Senior Scientific Advisor, ECHA, speaks about regulatory acceptance from a scientific and procedural point of view. Ms Kilian, Policy Officer, European Commission, DG ENVIRONMENT, Unit A.3, Chemicals, explains the process for incorporating validated tests into the EU Test Methods Regulation. She also gives a brief history of it and how it relates to REACH/CLP and other EU chemicals laws. Lastly, she presents a timeline for updates of the Regulation. |
The following poster, prepared for the Society of Toxicology 54th Annual Meeting, summarises the impact of the first five webinars in the 2014–2015 series and presents a case study illustrating how non-animal methods can be used to predict skin sensitisation in a weight-of-evidence assessment.
Effectiveness of toxicology-based webinars to promote nonstandard methods for REACH (poster) (2015)
Poster references:
1 OECD. 2015. Test No. 442C: In Chemico Skin Sensitisation, Direct Peptide Reactivity Assay (DPRA). Available at: http://www.oecd-ilibrary.org/environment/test-no-442c-in-chemico-skin-sensitisation_9789264229709-en
2 Gerberick G et al. 2004. Development of a peptide reactivity assay for screening contact allergens. Toxicological Sciences. 81(2):332-343. Available at: http://toxsci.oxfordjournals.org/content/81/2/332.long
3 Gerberick G et al. 2007. Quantification of chemical peptide reactivity for screening contact allergens: a classification tree model approach. Toxicological Sciences. 97(2):417-427. Available at: http://toxsci.oxfordjournals.org/content/97/2/417.long
4 OECD. 2015. Test No. 442D: In Vitro Skin Sensitisation, ARE-Nrf2 Luciferase Test Method. Available at: http://www.oecd-ilibrary.org/environment/test-no-442d-in-vitro-skin-sensitisation_9789264229822-en
5 Emter R et al. 2010. Performance of a novel keratinocyte-based reporter cell line to screen skin sensitizers in vitro. Toxicology and Applied Pharmacology. 245(3):281-90.
6 Emter R et al. 2013. Gene expression changes induced by skin sensitizers in the KeratinoSens™ cell line: Discriminating Nrf2-dependent and Nrf2-independent events. Toxicology In Vitro. 27(8):2225-2232.
7 Ramirez T et al. 2014. LuSens: A keratinocyte based ARE reporter gene assay for use in integrated testing strategies for skin sensitization hazard identification. Toxicology In Vitro. 28(8):1482-1497. Available at: http://www.sciencedirect.com/science/article/pii/S0887233314001556
8 Ashikaga T et al. 2006. Development of an in vitro skin sensitization testusing human cell lines: the human Cell Line Activation Test (h-CLAT). I. Optimization of the h-CLAT protocol. Toxicology In Vitro. 20(5):767-773.
9 Python et al. 2007. Assessment of the U937 cell line for the detection of contact allergens. Toxicology and Applied Pharmacology. 220(2):113-124.
10 OECD. 2010. Test No. 429: Skin Sensitisation, Local Lymph Node Assay. Available at: http://www.oecd-ilibrary.org/environment/test-no-429-skin-sensitisation_9789264071100-en
11 OECD. 1992. Test No. 406: Skin Sensitisation. Available at: http://www.oecd-ilibrary.org/environment/test-no-406-skin-sensitisation_9789264070660-en
12 ECHA, 2011. The Use of Alternatives to Testing on Animals for the REACH Regulation. Available at: http://echa.europa.eu/documents/10162/13639/alternatives_test_animals_2011_en.pdf (accessed 20 March 2015)
13 ECHA, 2014. The Use of Alternatives to Testing on Animals for the REACH Regulation, Second report under Article 117(3) of the REACH Regulation. Available at: http://echa.europa.eu/documents/10162/13639/alternatives_test_animals_2014_en.pdf (accessed 20 March 2015)
14 European Ombudsman, 2014. Decision of the European Ombudsman closing the inquiry into complaint 1568/2012/(FOR)AN against the European Chemicals Agency (ECHA). Available at: http://www.ombudsman.europa.eu/cases/decision.faces/en/58549/html.bookmark (accessed 20 March 2015)