Evaluation of Skin Sensitization under REACH

Introduction

The course is designed to provide a thorough understanding of the evaluation of skin sensitization potential of substances being registered under the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation (EC) No. 1907/2006. Participants will understand the biological aspects of the skin sensitization pathway which is of primary importance for the selection of the testing strategy. Pros & cons of the in-vitro as well as the in-vivo tests will be presented and related to the IATA (integrated approaches to testing and assessment).

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Program

The course will focus on the following topics:

• Introduction:
  • Overview of REACH regulation for chemical safety.
  • Importance of assessing skin sensitization to protect health.
• Skin Sensitization:
  • Allergic reaction from repeated exposure to sensitizers.
  • Mechanism involves induction and elicitation phases.
• REACH Requirements:
  • Annex VII and VIII mandate information on skin sensitization.
• Testing Methods: pros & cons:
  • In vitro/in chemico: OECD 442 C, D, E
  • In vivo: LLNA, Buehler, GPMT.
• Testing Strategy:
  • Use IATA for a weight-of-evidence approach (OECD 497).
  • Start with non-testing and in vitro methods, progressing to in vivo if needed.

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To whom

This course is ideal for regulatory professionals and companies that willing to increase their understanding of the technical and regulatory aspects of skin sensitization testing strategy.

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Course information request

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