Testing for Cytotoxicity-Compliance with REACH and the 7th amendment

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
  • Safety Assessment
  • Formulations Development
  • Regulatory Affairs
  • Product 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, with the positions, market leads and sources for information. The core of the course is focused on the understanding of current available methodologies, their scope and limitations. Testing for cytotoxicity of a compound provides a fundamental initial understanding for its potential safety upon exposure to viable cells and tissues. Over the years numerous methods have been developed and validated using a variety of cell lines, markers, quantitative and qualitative analyses. Since organ malfunction or failures are associated with cell death, cytotoxicity testing is also used as an end point for evaluation of eye and skin irritation, and photo-toxicity. An effort is put together by regulatory parties to assess the validity of cytotoxicity as a predictive measure for acute toxicity

Module 1: Definitions:
  • Cytotoxicity
  • When is a compound defined as cytotoxic?
  • Types of cells and cell cultures
  • Relevance to the industry- can cosmetic 
    ingredients be cytotoxic?
  • Consideration in study design

Module 2: Regulatory status:
  • Cytotoxicity as a measure for the
     following end points:
    – Eye and skin irritation 
    – Photo-toxicity
    – Acute toxicity
  • ECVAM’s and ICCVAM positions

Module 3: Suggested models:
  • Neutral red release
  • Red blood cell
  • Fluorescein leakage
  • Silicon/cytosensor microphysiometer

Summary and future direction

Question and Answer Session

• The research and understanding of the interaction between topically applied compounds and the skin.
• Findings in skin biochemistry and especially the upper layer of the skin- the stratum corneum
• Delivery of active compounds into and through the skin and the development of delivery systems to facilitate transport, improve bio-availability and reduce toxicity
• Design and development of topically applied formulations
• Design of clinical studies to substantiate market claims and to assure safety
• Academic teaching and lecturing
• Industrial experience in both development of active compounds, delivery systems and finished formulations
• Skin absorption studies in vivo and in vitro for safety/ efficacy assessment
• In vitro methodologies for safety assessment of topically applied compounds