REACHing for alternatives to animal testing

A webinar series on modern testing strategies for REACH

The PETA International Science Consortium, Ltd., and Chemical Watch presented a free webinar series focusing on alternative methods and testing strategies that can be used to meet REACH requirements. The webinars, available below, are of interest to industry toxicologists, those registering chemicals for the first time, companies who would like to know more about validated nonanimal tests that are available and how companies are using them, and REACH consultants.

 

WEBINAR 1: OECD QSAR TOOLBOX AND READ-ACROSS
October 22, 2014
Speakers:
Dr. Grace Patlewicz, DuPont
Prof. Mark Cronin, Liverpool John Moores University
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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 will briefly discuss the use of integrated approaches to testing and assessment and adverse outcome pathways to organize existing information and plan a nonanimal testing strategy. Specifically, they will discuss how QSARs and read-across can be used to meet REACH requirements and will detail the use of the OECD QSAR Toolbox. There will also be a discussion of future research projects.
WEBINAR 2: SKIN IRRITATION AND CORROSION
November 11, 2014
Speakers:
Dr. Gertrude-Emilia Costin, Institute for In Vitro Sciences
Dr. Costanza Rovida, REACH Mastery and CAAT Europe
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Click here for a copy of the Q&A from the session
Dr. Costin will describe 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 will explain 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 
December 4, 2014
Speakers:
Dr. Kim Norman, Institute for In Vitro Sciences
Dr. João Barroso, EURL ECVAM
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Drs. Norman and Barroso will 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, will be described.
WEBINAR 4: SKIN SENSITIZATION
January 28, 2015
Speakers:
Dr. Susanne Kolle, BASF SE
Dr. Silvia Casati, EURL ECVAM
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Dr. Kolle will first discuss data requirements and in vivo classification for skin sensitisation in order to define what is required to replace the animal test. Dr. Casati will provide an overview of the key mechanism of skin sensitization, based on the published adverse outcome pathway, and describe 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 will then discuss examples of how these methods can be combined in testing strategies / integrated approaches. She will also present 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 will close by reviewing current OECD activities in the field of skin sensitisation.
WEBINAR 5: ALTERNATIVE APPROACHES TO MAMMALIAN ACUTE SYSTEMIC TOXICITY TESTING
March 5, 2015
Speakers:
Dr. Pilar Prieto, EURL ECVAM
Dr. Lawrence Milchak, 3M
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Dr. Pilar Prieto will present 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 provides 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 will speak to industry experiences on the use of alternative strategies to meet acute toxicity testing requirements.
WEBINAR 6:  (ZEBRA)FISH EMBRYO ACUTE TOXICITY TEST TO PREDICT SHORT TERM TOXICITY TO FISH (AND BEYOND)
April 14, 2015
Speakers:
Dr. Marlies Halder, EURL ECVAM
Prof. Thomas Braunbeck, University of Heidelberg
Dr. Scott Belanger, Procter & Gamble
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In this webinar, Dr. Halder will begin by describing the REACH data requirements for short term toxicity testing on fish and the OECD acute fish toxicity test (OECD TG 203). She will then describe 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 will provide an assessment of the correlation between the OECD acute fish toxicity test and the fish embryo toxicity test. This will include an assessment of the domain of applicability and the possibility of using the FET in traditional fish Quantitative Structure Activity Relationships.  Prof. Braunbeck will then describe the potential use of fish embryos beyond acute fish toxicity testing and provide 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 NONANIMAL TESTS
June 10, 2015
Speakers:
Dr. Derek Knight, ECHA
Ms. Karin Kilian, European Commission
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Derek Knight, Senior Scientific Advisor, ECHA, will speak about regulatory acceptance from a scientific and procedural point of view. Karin Kilian, Policy Officer, European Commission, DG ENVIRONMENT, Unit A.3, Chemicals, will explain the process for incorporating validated tests into the EU Test Methods Regulation.  She will also give a brief history of it and how it relates to REACH/CLP and other EU chemicals laws. Finally, she will present a timeline for updates of the Regulation.

The following poster, prepared for the 54th annual Society of Toxicology meeting, summarizes the impact of the first five webinars in this series and presents a case study illustrating how nonanimal 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)