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ECVAM Key Area Sensitisation: Overview on Activities Silvia Casati, Chantra Eskes

ECVAM Key Area Sensitisation: Overview on Activities Silvia Casati, Chantra Eskes. Research Activities. Collaboration with industries. Support to policies: Cosmetics Directive REACH. Test development Prevalidation/Validation. Refine Reduce Replace. LLNA related activities.

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ECVAM Key Area Sensitisation: Overview on Activities Silvia Casati, Chantra Eskes

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  1. ECVAM Key Area Sensitisation: Overview on Activities Silvia Casati, Chantra Eskes

  2. ResearchActivities Collaboration with industries • Support to policies: • Cosmetics Directive • REACH Test development Prevalidation/Validation Refine Reduce Replace LLNA related activities ECVAM Key Area Sensitisation Task Force input

  3. Sens-it-iv Novel Testing Strategies for In Vitro Assessment of Allergens Budget: 11 M€ Partners: 28 (including universities, research institutes, industries, SMEs, JRC) Coordinator: Erwin Roggen (Novozymes) Duration: October 2005 – November 2010 Deliverable In vitro tests and test strategies ready to be validated, allowing the testing of the sensitising potency of existing and new chemical entities for classification and labelling and for the purpose of risk assessment. • Sens-it-iv aims to develop assay systems that model sensitisation, rather than irritation and toxicity of chemicals and proteins. • The innovative aspect of the project is the coordinated and extensive characterisation of the impact of compounds on cell-cell interactions for the identification of the key mechanisms involved in sensitisation.

  4. Sens-it-iv Structure Sens-it-iv Structure Science module (Months 0-36) (Months 0-60) WP9: Technology transfer & Dissemination WP1: Compound Selection WP2: EC- DC interactions and biology WP3: DC – T-cell Interactions and biology WP7: Data Management WP6: Metabonomics WP10: Project management (Months 0-60) WP8: In vitro assay development WP5: Proteomics WP4: Genomics Technology module (Months 0-60)

  5. ECVAM Involvement in Sens-it-iv Coordination Board E. Roggen (coordinator) H. Weltzien (vice-coordinator IPR, Financial and legal Officers WP1: Chemicals Selection WP1: EC - DC interactions WP3: DC - T-cell interactions WP4: Genomics WP5: Proteomics WP6: Metabonomics WP7: Data Management WP8: In vitro assays development WP9:Technology transfer & dissemination WP10: Project management European Commission Advisory Committees Steering Committee E. Roggen, S. Casati, O. De Silva D. Basketter, I. Kimber, H. Weltzien Management Team E. Roggen, S. Casati, C. Borrebaeck F. Sallusto, H.J. Thierse, K. Park, C. Helma, S. Gibbs, H. Hermans WP10 WP1 WP2 WP9 WP3 WP8 WP4 WP7 WP5 WP6 General Assembly

  6. Sens-it-iv WP1: 24 Months Achievements • Selection of a tutorial set of compounds • Repository established in ECVAM and chemicals distribution to other partners • Procedures for chemicals handling • Extended list of chemicals for subsequent project phases • Database under development on physico-chemical properties of compounds and published in vitro and in vivo data (human and animal)

  7. Skin penetration Protein binding EC EC DC activation DC migration DC TCELL DC- T cell interactions Memory T cells Relevant Workshops “The relevance of epidermal disposition for sensitisation hazard identification and risk assessment” (2006) “Chemical reactivity measurement and the predictive identification of skin sensitisers” (2007) “Dendritic cells as a tool for a predictive identification of skin sensitization hazard” (2004) Others Chemical Respiratory Allergy: Opportunities for Hazard Identification and Characterisation

  8. Collaboration with Industries Definition of a set of reference chemicals for methods development and evaluation

  9. The LLNA and REACH Regulation (EC) N. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Applies to new and about 30,000 existing substances Annex VII Standard information requirements for substances manufactured or imported in quantities of 1 tonne or more The LLNA is the first-choice method for in vivo testing Only in exceptional circumstances should another test be used Justification for the use of another test shall be provided • Skin sensitisation: • An assessment of the available human, animal and alternative data • In vivo testing

  10. Under Peer Review • Workshop on: “Alternative Endpoints for the LLNA” Ispra, 25-27 September 2007 • Method under evaluation • Peer-review panel being established • ESAC statement - April ’07 • Inclusion into RIP 3.3 TGD • Draft TG submitted to CA LLNA Related Activities • LLNA Performance Standards • Modifications to the standard LLNA incorporating non-radioactive endpoints • Validation of the standard LLNA for the purposes of measuring relative potency using EC3 values • Reduced LLNA

  11. Reduced-LLNA Revised approach of the standard LLNA to reduce animal use in skin sensitisation testing • Reduced-LLNA • top concencentration test chemical • + vehicle control • 4-5 mice/group • Standard LLNA • 3 concencentrations test chemical • + vehicle control • 4-5 mice/group 16-20 mice 8-10 mice Does not provide information on potency For risk assessment purposes a standard LLNA should be conducted

  12. For further information on ECVAM activities please contact: silvia.casati@jrc.it For further information on Sens-it-iv please access: http://www.sens-it-iv.eu/

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