Course offering number:0912-705
Course ID:
2280
Testing for Genotoxicity, Mutagenicity and Carcinogenicity: Compliance with REACH and the 7th Amendment
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
Professionals in the cosmetic and personal care or related industries that work and specialize in the following disciplines, as well as groups or
companies that provide services in skin care in the following fields:
• Research and Development
• Regulatory Affairs
• Safety Assessment
• Product Development
• Formulations Development
Description
With the unique position of the cosmetic and personal care industry of animal testing ban and emergence of REACH, this course is designed to
present key parties involved, their positions, market leads and sources for information.
Compounds that can change the genetic information of a living cell may lead to mutations. These can result in different type of toxic effects,
ranging from cell death to the development of a malignant tumor. While a variety of methodologies are currently in use in the area of regulatory
genotoxicity, substantial in vivo testing is still required for the confirmation of genotoxic prediction. For the evaluation of carcinogenicity, the only
accepted test by regulatory agencies is the in vivo two year bioassay. Therefore, in 2004, ECVAM initiated several activities related to the
validation of alternative methods and applied research.
The core of the course is focused on the understanding of current available methodologies, their scope and limitations, including:
Module 1:
• Definitions
– Genotoxicity/Mutagenicity
– Carcinogenicity
• Relevance to the industry
• ECVAM's position
• ICCVAM's position
Module 2:
• Testing for Genotoxicity/Mutagenicity:
– Human Hepatocytes Model
– COMET assay in 3D skin model
– BALB/c 3T3 model
– Chromosomes aberration test
Module 3:
• Testing for Carcinogenicity
– The in vivo two year bioassay
– Cell transformation assay in BALB/c 3T3 and SHE
– Micronucleus test
Summary and Future Direction
Question and Answer Session