Introduction:
The course is designed to provide a thorough understanding of the evaluation of genetic toxicity for substances being registered under the REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation (EC) No. 1907/2006. Participants will gain in-depth knowledge of the various in-vitro and in-vivo assays used to assess the genotoxicity potential of chemicals. The course will cover the specific requirements based on the tonnage band of the registered substances, discuss peculiar cases of applicability, and address common challenges and problems related to genetic toxicity evaluation. This course is ideal for regulatory professionals and companies that willing to increase their understanding of the technical and regulatory aspects of genetic toxicity evaluation.
Program:
The course will focus on the following topics:
- Definitions: Mutagenicity, Genotoxicity
- How to comply with the REACH Regulation
- In-vitro assays:
- OECD TG 471: Bacterial Reverse Mutation Test (Ames Test)
- OECD TG 473: In-vitro Mammalian Chromosome Aberration Test
- OECD TG 476: In-vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes
- OECD TG 487: In-vitro Mammalian Cell Micronucleus Test
- OECD TG 490: In-vitro Mammalian Cell Gene Mutation Tests using the Thymidine Kinase gene
- In-vivo assays:
- OECD TG 474: Mammalian Erythrocyte Micronucleus Test
- OECD TG 475: Mammalian Bone Marrow Chromosomal Aberration Test
- OECD TG 478: Rodent Dominant Lethal Test
- OECD TG 483: Mammalian Spermatogonial Chromosomal Aberration Test
- OECD TG 486: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo
- OECD TG 489: In-vivo Mammalian Alkaline Comet Assay
- OECD TG 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays
- Specific applications and current limitations
To whom:
This course is aimed at the regulatory departments of structured companies involved in conducting and evaluating genetic toxicity tests for the preparation of REACH registration dossiers, and at consultants who want to learn more about this topic.
Teacher/Speaker:
Federica Vecchies
Language:
Italian
(available in English upon request)
Duration:
2 hours
Cost:
170 €/person
