SOT FDA Colloquium Upcoming on December 12: “Dermal Absorption and Toxicity: Concepts for Application to Safety Assessment”

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SOT and the US Food and Drug Administration (US FDA) Center for Food Safety and Applied Nutrition (CFSAN) cordially invite you to join us for our December 12 colloquium, “Dermal Absorption and Toxicity: Concepts for Application to Safety Assessment.” This session is open to the public to attend in person or via webcast at no charge. These colloquia are an update on toxicological science and not a public forum for discussion of toxicology regulatory issues. The colloquium will take place from 8:30 am to 12:50 pm (ET) in the Wiley Auditorium at US FDA in College Park, Maryland. The Chair of the colloquium is Nancy Monteiro-Riviere of North Carolina State University and Kansas State University, and the Co-Chair is Jeffrey Yourick of US FDA.

Dermal absorption information is needed to conduct a realistic exposure assessment for a chemical that is directly applied to skin or otherwise comes in contact with skin. If a potentially hazardous chemical/ingredient has been identified that contacts skin, then the next step in the process of safety evaluation is to estimate human exposure. Systemic exposure resulting from skin contact is a function of many different properties, including the amount of chemical applied to the skin, the duration of skin contact, the area of body contact, chemical physiochemical properties, and the extent of dermal absorption. If no data are available for specific exposure conditions for a chemical, then reasonable estimates of these parameters must be used. This colloquium will explore how different factors can affect the extent of dermal absorption, such as skin structure, dermal absorption measurement techniques (in vivo and in vitro), skin metabolism, use of skin absorption kinetic modeling techniques, physiochemical properties, mixtures, formulations, and some case study examples. A reasonable estimate of human exposure to a topically applied chemical can be calculated if the extent of skin absorption is realistically determined.

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Presentations include:

8:30 AM–8:40 AM

Welcome and Introduction of Speakers
Jeffery Yourick, US FDA, College Park, MD

8:40 AM–9:15 AM        

Introduction to the Comparative Anatomical Factors Affecting Topical Skin Delivery
Nancy Monteiro-Riviere, North Carolina State University, Raleigh, NC, and Kansas State University, Manhattan, KS

9:15 AM–9:50 AM

Simulation and Modeling of Dermal Absorption Kinetics: What Level of Detail Is Needed?
Gerald Kasting, University of Cincinnati, Cincinnati, OH

9:50 AM–10:25 AM

Assessing Mixture and Formulation Influence on Skin Absorption
Ronald Baynes, North Carolina State University, Raleigh, NC

10:25 AM–10:40 AM Break
10:40 AM–11:15 AM

Cutaneous Metabolism and Its Importance for Skin Permeation and Toxicity
Simon Charles Wilkinson, Newcastle University, Newcastle upon Tyne, United Kingdom

11:15 AM–11:50 AM

Practical Considerations for Incorporating Skin Penetration Data into a Risk Assessment for a Consumer Product Launch
Tim McCarthy, Johnson & Johnson, Skillman, NJ

11:50 AM–12:50 PM

Roundtable Discussion
Moderator: Nancy Monteiro-Riviere, North Carolina State University, Raleigh, NC, and Kansas State University, Manhattan, KS
All Speakers
Nakissa Sadrieh, US FDA, College Park, MD

Questions concerning the regulatory science are encouraged from the audience on-site and from webcast participants for the roundtable discussion. Regulatory policy will not be discussed.

The SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety present scientific training that is high-quality, cutting-edge, future-oriented toxicological science for US FDA employees and are open to the public at no cost.

Recordings and slides from the previous colloquia are available free via the SOT FDA colloquia web page, including the May 15, 2019, session, “In Silico Methods for Food Ingredient, Dietary Supplement, and Cosmetic Safety.”

Upcoming colloquia scheduled for 2020 include:

  • February: “Route-Route Extrapolation for the 21st Century”
  • April: “Artificial Intelligence in Food and Cosmetic Safety”
  • May: “Integrated Approaches to Testing and Assessment—The Future of Predictive Toxicology”
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