Cosmetics Europe LRSS Programme

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1 Cosmetics Europe LRSS Programme Rob Taalman

2 Objectives of CE Research To deliver tools & strategies for animal-free safety assessment Accurate Robust Efficient ultimately accepted by regulators

3 Our Systematic Rationale Exposure Exposure upon use Local effects Skin, eye irritation Penetration, Metabolism, Excretion Skin penetration, metabolism Bioavailability at systemic target site Systemic Effects Sensitization, genotoxicity (Sub-) chronic toxicity Safety Assessment

4 Current LRSS Situation LRSS = triple package ❶Develop non-animal methods & testing strategies to be used for safety assessment of cosmetics ingredients / chemicals ❷Show that safety assessment thus probabilistic & realistic assessment is possible on a broad spectrum of effects / likelihoods including systemic toxicity ❸Advocate for the regulatory acceptance of data generated with such alternative methods

5 Current LRSS Situation 5 task forces 1. Eye Irritation 2. Genotoxicity 3. Skin tolerance 4. Bioavailability & Metabolism / ToxicoKinetics (TK) 5. Mode of Action / ToxicoDynamics (TD) Well advanced combination of alternative methods towards reg. accep. Systemic toxicity based on non-animal methods only Big challenge Discussed for decades Many attempts to achieve this But so far not accepted

6 AAT Strategic Roadmap 2013 Skin Irritation Eye Irritation Genotoxicity Acute Toxicity 2020 Sensitization Systemic Toxicity 2016 Eye Irritation Genotoxicity Skin sensitization Exposure / ADME Systemic Toxicity

7 Eye Irritation

8 Eye Irritation Strategy 2012

9 Eye Irritation Today ( ) X

10 Genotoxicity

11 Evolution of Genotoxicity Requirements SCCS Notes of guidance in vitro battery: Ames MLA MN Ames MN 3D Comet 3D MN High Sensitivity Low false positive ratio Reduced costs Skin assays accepted followup option Successful Validation is prerequisite for maintaining We personally status quo! care

12 Genotoxicity Strategy supported by SCCS and OECD Drastically less false positives by 2-assay strategy Evaluation of tier 2 assays progressing Finalize validation of 3D skin model assays in 2016 Support validation of Hen s Egg micronucleus test as viable option to follow-up on orally exposed ingredients Goal to have 2 assays/strategy approved by scientific/regulatory community in 2017/18

13 Skin Sensitization

14 Skin Sensitization - OECD Adverse Outcome Pathways - Chemistry Penetration Metabolism Immunology Chemical reactivity Protein modification Cellular response Organ response In vivo response Integrated assessment Expert systems in silico tools

15 Skin Sensitization - OECD Adverse Outcome Pathways - Chemistry Penetration Metabolism Immunology Chemical reactivity Protein modification Cellular response Organ response In vivo response Three in vitro assays validated DPRA, KeratinoSens, hclat Additional 13 assays evaluated Six methods prioritized (incl. DPRA, KeratinoSens and hclat) Promising prediction models being assessed e.g. Support Vector Machines, Bayesian models

16 Skin Sensitization - OECD Adverse Outcome Pathways - Chemistry Penetration Metabolism Immunology Chemical reactivity Protein modification Cellular response Organ response In vivo response Researching assays

17 Overview Skin Sensitization Achievements Assays developed / validated / evaluated Clear roadmap Challenges ( ) Potency determination Testing strategy finalization Regulatory acceptance Status 6 OECD-submitted data interpretation procedures (DIP s) evaluated Assay optimization & data integration Characterize & expand applicability domain

18 Systemic Toxicity

19 Back to the basics

20 Paradigm shift QIVI VE *adapted from P. Price (US EPA), Using in vitro data in quantitative risk assessments

21 Strategy Systemic Toxicity Exposure - Toxicokinetics - Systemic exposure predictions Hazard Identification - Toxicodynamics - Mechanistic predictions Fusion Concentration response data Modelling - Case Studies - Safety Assessment Combined evaluation & extrapolation

22 Systemic Toxicity - Status SEURAT-1 final event 4 Dec SEURAT-1 level 3 case studies Proof-of-concept, TTC, Read-across framework, ab initio Differential planning vs. public programs

23 Toxicokinetics / ADME - Objectives Internal exposure For read-across and ab initio risk assessments Enable internal TTCs Guidance for in vitro assays (concentrations, target organs)

24 Toxicokinetics / ADME - Principles Fate of a chemical after exposure via different routes Topical exposure Local concentrations in different organs Metabolism Distribution Excretion Organ-specific toxicity Reactive metabolite formation or detoxification PK profile, C max, AUC

25 Toxicokinetics / ADME - Status Protein binding Solubility Partition/ diffusion coefficients Lipid binding (Physico-) chemical properties In silico models In silico models Skin penetration (non-viable skin) Bioavailability & Metabolism Metabolism in ex vivo skin Metabolism, stability in S9 50 compounds tested Q3/2016 In silico models 2017

26 Toxicokinetics / ADME - Way Forward Exposure In silico Skin Penetration Prediction Models ADME in vitro Toolbox intestinal absorption liver metabolism in vitro biokinetics plasma protein binding Static & Dynamic 3D Skin & Liver Models Internal TTC PBPK ADME Model Read across / ab initio concepts

27 Toxicodynamics - Objectives Discriminate between specific and non specific adversities and low toxicity Determine perturbed biological pathways for repeat dose toxicity Establish quantitative points of departure for use in risk assessment (linked to kinetics)

28 Toxicodynamics Building Blocks Mode of Action Ontology ( ) Bio-/ Chemoinformatics Data ( ) Toxicogenomics ( ) Toxicodynamic AssayToolbox ( ) Quantify dose which can alter biological pathway(s)

29 Toxicodynamics Building Blocks Mode of Action Ontology ( ) Bio-/ Chemoinformatics Data ( ) Toxicogenomics ( ) Toxicodynamic AssayToolbox ( )

30 Toxicodynamics Building Blocks - Mode of Action Ontology - Knowledge-based grouping of chemical features associated with repeat dose toxicity into categories, tie to a putative mode of toxicity (or not) Mode of Action Ontology Bio-/ Chemoinformatics Data ( ) ( ) Toxicogenomics ( ) Toxicodynamic AssayToolbox ( )

31 Toxicodynamics Building Blocks - Toxicogenomics - Front line screen for broad characterization of hazard Mode of Action Ontology Bio-/ Chemoinformatics Data ( ) ( ) Toxicogenomics ( ) Toxicodynamic AssayToolbox ( )

32 Toxicodynamics Building Blocks - Toxicodynamic Assay Toolbox - In vitro assays for generating toxicodynamic data Address identified gaps Source of targeting testing Mode of Action Ontology Bio-/ Chemoinformatics Data ( ) ( ) Toxicogenomics ( ) Toxicodynamic Assay Toolbox ( )

33 Toxicodynamics Building Blocks - Bio-/ Chemo-informatics Data - Informatics and integration/visualization needs of toxicity and ADME data for analysis via case studies Mode of Action Ontology Bio-/ Chemoinformatics Data ( ) ( ) Toxicogenomics ( ) Toxicodynamic AssayToolbox ( )

34 Fusion & Safety Assessment - Case Studies / Modelling / Evaluation - Case Studies as Guiding Principle Concentration response data / modelling Quantitative in vitro-in vivo extrapolation (QIVIVE)

35 Systemic Toxicity Workflow TIER 0: IDENTIFY USE SCENARIO, CHEMICAL OF CONCERN AND COLLECT EXISTING INFORMATION TIER 1: HYPOTHESIS FORMULATION TIER 2: APPLICATION 1. IDENTIFY USE SCENARIO 2. IDENTIFY MOLECULAR STRUCTURE 3. COLLECT EXISTING DATA 4. IDENTIFY ANALOGUES, SUITABILITY ASSESSMENT AND EXITING DATA 5. SYSTEMIC BIOAVAILABILITY (PARENT VS. METABOLITE(S), TARGET ORGANS, INTERNAL CONCENTRATION) 6. MOA HYPOTHESIS GENERATION (WEIGHT OF EVIDENCE BASED ON AVAILABLE TOOLS) 7A. TARGETED TESTING 7B. BIOKINETIC REFINEMENT (IN VIVO CLEARANCE, POPULATION, IN VITRO STABILITY, PARTITION) 8. POINTS OF DEPARTURE, IN VITRO IN VIVO EXTRAPOLATION, UNCERTAINTY ESTIMATION, MARGIN OF SAFETY EXIT TTC EXIT READ ACROSS EXIT INTERNAL TTC 9. FINAL RISK ASSESSMENT OR SUMMARY ON INSUFFICIENT INFORMATION APPROACH EXIT AB INITIO (Adapted from Berggren et al Publication in preparation)

36 It s all connected

37 SA Paradigm = the common matrix to TK and TD TFs There are some direct links easy to draw And some others less obvious

38

39 Conclusions Highlights since 2015 OECD acceptance of eye irritation RhT tests OECD/SCCS acceptance of genotoxicity strategy SEURAT-1 case studies SCCS: positive reception of TTC for systemic toxicity ECHA: positive reception of NAMs (as supporting evidence in read-across) Cosmetics Europe LRSS roadmap largely planned

40 AAT Means Collaboration! Regulators - OECD - ECVAM - SCCS Industry - Cosmetics (LRSS) - Pharma (IMI) - Life Science - Chemicals (LRI) - ECETOC EPA EPAA Public Sector - E.C. (Horizon 2020) - JRC - Academia, institutes Thank you!

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