The OECD Framework for AOP Development and Application

Transcription

1 The OECD Framework for AOP Development and Application Magda Sachana NC3Rs: Pathways-based approaches across the biosciences: Towards application in practice Thursday 28 April 2016, London

2 Presentation Outline OECD AOP Development Programme OECD Survey to explore the utility of AOPs for regulatory assessment of chemicals and to identify development priorities Use of AOPs in developing Integrated Approaches to Testing and Assessment (IATA) 2

3 OECD AOP Development Programme

4 AOP s central role in OECD work on predictive toxicology AOPs Sample text Development of IATA for defined hazard endpoints This is a sample text. OECD Hazard Insert your Assessment activities desired text here.

5 Selection of methods for Test Guideline development/refinement

6 AOP s central role in OECD work on predictive toxicology AOPs Sample text Development of IATA for defined hazard endpoints This is a sample text. OECD Hazard Insert your Assessment activities desired text here.

7 Development of (Q)SARs

8 AOP s central role in OECD work on predictive toxicology AOPs Sample text Development of IATA for defined hazard endpoints This is a sample text. OECD Hazard Insert your Assessment activities desired text here.

9 Main milestones achieved since the launch of the OECD AOP Development Programme Future: Increase the AOP- KB content and facilitate the use of AOPs in a regulatory context 2016 Endorsement of 5 AOPs by WNT 2012 OECD AOP Development Programme 2014 AOP-KB and Users' Handbook supplement to the guidance document for AOPs 2015 External review of AOPs and training material for AOP development 2013 Guidance document on developing and assessing AOPs

10 Effectopedia (in beta testing) Collaborative development of quantitative AOPs in graphical environment AOP Wiki Collaborative development of AOP descriptions & evidence AOP Xplorer Visualize attribute networks to discover & explore AOPs in a broader context Intermediate Effects DB Chemical-related data derived from non-apical endpoint methods e.aop Portal AOP-KB Third party Applications, plugins Shared chemical, biological and toxicological ontologies

11 Interlinkages between systems - data exchange AOP Wiki Effectopedia AOP Xplorer Intermediate Effects DB AOP-KB Hub MetaPathh Electronic Pesticide Submission Package

12 OECD Survey to explore the utility of AOPs for regulatory assessment of chemicals and to identify development priorities

13 Experience with the AOP framework (familiarity) Not at all (1) To a small extent (2) To a moderate extent (3) To a fairly great extent (4) To a great extent (5)

14 Experience with the AOP framework (source of experience) OECD activities Scientific literature/meetings Colleague(s) Other

15 Experience with the AOP framework (participation in development or review of AOPs) 60.00% 54.05% 50.00% 40.00% 29.73% 30.00% 20.00% 13.51% 10.00% 2.70% 0.00% Author Co-author Reviewer No experience

16 AOPs in AOP-Wiki and coverage of toxicological endpoints 60.00% 54.29% 50.00% 40.00% 30.00% 25.71% 20.00% 8.57% 11.43% 10.00% 0.00% Not at all (1) To a small extent (2) To a moderate extent (3) To a fairly great extent (4)

17 Other toxicological endpoints to be addressed by AOPs in the AOP-Wiki (1) Endocrine disruption Carcinogenicity Genotoxicity Reproductive and developmental toxicity Repeated dose toxicity Respiratory toxicity Immunotoxicity Ecotoxicological endpoints

18 Other toxicological endpoints to be addressed by AOPs in the AOP-Wiki (2) There is need for a systematic review of regulatory needs and the pathways involved A call for AOPs relating to the identified pathways

19 Is the information provided in the AOPs useful for your regulatory needs? 40.00% 34.29% 37.14% 35.00% 30.00% 25.00% 20.00% 20.00% 15.00% 8.57% 10.00% 5.00% 0.00% Not at all (1) To a small extent (2) To a moderate extent (3) To a fairly great extent (4)

20 Use of the information available in the AOP-Wiki by agencies/organisations 60.00% 54.55% 50.00% 40.00% 30.00% 24.24% 18.18% 20.00% 10.00% 3.03% 0.00% Not at all (1) To a small extent (2) To a moderate extent (3) To a fairly great extent (4)

21 Use of AOP concept by agencies/ organisations 35.00% 31.43% 34.29% 30.00% 25.00% 20.00% 15.00% 14.29% 17.14% 10.00% 5.00% 2.89% 0.00% Not at all (1) To a small extent (2) To a moderate extent (3) To a fairly great extent (4) To a great extent (5)

22 Regulatory need(s) in which the AOP concept was used Prioritisation 13% 6% 20% Grouping of chemicals and subsequent Read across IATA development 25% 21% Classification and Labelling 5% 10% Hazard Assessement Risk assessment

23 Suggestions on how to improve AOPs usability Quantitative AOPs Linking of AOPs to regulatory endpoints and test guidelines Development of guidance/framework for reporting and applying AOPs for regulatory applications Training in interpreting AOPs and applying in a weight of evidence approach.

24 Use of AOPs in developing Integrated Approaches to Testing and Assessment (IATA)

25 Framework for how an AOP can be applied to inform and structure IATA

26 Reporting Defined approaches For Official Use ENV/JM/HA(2016)10 ENV/JM/HA(2016)10 For Official Use Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development English - Or. English ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY Task Force on Hazard Assessment Guidance Document on the Reporting of Defined Approaches to be used within Integrated Approaches to Testing and Assessment ENV/JM/HA(2016)11 For Official Use For Official Use ENV/JM/HA(2016)11 Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development English - Or. English ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY Task Force on Hazard Assessment This is a draft document, the work is still in progress. This document is intended for the use of ECHA MSC/RAC members only and for no further circulation. Guidance Document on the Reporting of Defined Approaches to Testing and Assessment for Skin Sensitisation This is a draft document, the work is still in progress. This document is intended for the use of ECHA MSC/RAC members only and for no further circulation. English - Or. English Complete document available on OLIS in its original format This document and any map included herein are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area. English - Or. English Complete document available on OLIS in its original format This document and any map included herein are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area.

27 THANK YOU