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).
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.
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.
Teacher/Speaker:
Federica Vecchies
Language:
Italian
(available in English upon request)
Duration:
2 hours
Cost:
170 €/person
