Dermal Absorption and Toxicity: Concepts for Application to Safety

Assessment December 12, 2019

Welcome, Overview, and Speaker Introductions

Jeffrey Yourick, PhD

Division of ToxicologyOffice of Applied Research and Safety Assessment

Center for Food Safety and Applied NutritionUS Food and Drug Administration

Welcome, Overview, and Speaker Introductions

Society of Toxicology and US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series.

Provide high-quality, cutting-edge, future-oriented toxicological science

Provide well-grounded foundation to inform the work of US FDA employees.

Welcome, Overview, and Speaker Introductions

These colloquia are open to the public to attend in person or via webcast.

These colloquia are not a public forum for discussion of toxicology regulatory issues.

0

100

200

300

400

500

600

700

800On-Site - FDA Employee

On-Site - Non FDA Employee

Webcast - FDA Employee

Webcast - Non FDA Employee

SOT FDA Colloquium Attendance (all 5 years)

Meeting Average 60 On-site

282 Webcast336 Total

Total onsite participation for the series is 960 and webcast attendance 4,618

Colloquium Material Page Views

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000Rodent BioassayFood AllergyMetabolomicsMixturesIVIV ConcordanceFood PackagingAdversityIVIVEDev NeurotoxChildrenCramerMOAComputationalRisk AssessmentImmunotoxADME/PKPHOs

2015 20192016 20182017

Total of 309,808 page views

Average of 19,363 views per colloquium

Average of 76 video playbacks per colloquium

2018-2019 Webcast Registration by Country

34 CountriesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaDenmarkFinlandFranceGermanyGreat Britain/UKHong KongIndiaItalyJapanLibyaMacedoniaMexicoMongoliaNetherlandsNorwayPakistan

PolandSaudi ArabiaSingaporeSouth KoreaSpainSwitzerlandTaiwanThailandTurkeyUnited StatesVirgin Islands

FDA’s Predictive Toxicology Roadmap

https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap

Roadmap Goals:

• Foster the development and evaluation of emerging toxicological methods and new technologies

• Incorporate these methods and technologies into regulatory review, as applicable.

Division of Toxicology – CFSAN/Office of Applied Research and Safety Assessment (OARSA)

Key Research Initiatives:

• Stem cell models for tox testing• Dermal and buccal absorption• In vitro renal and gastrointestinal models• Liver organ chip -hepatotoxcity• Bioprinting• In silico models for tox testing• Alternative animal models

Today’s Colloquium-Dermal Absorption and Toxicity: Concepts for Application to Safety Assessment Dermal absorption information is needed to conduct a realistic

exposure assessment for a chemical that contacts skin. Safety evaluation begins with an estimate of dermal human exposure. Dermal exposure is a function of:

– the amount of chemical applied to the skin– the duration of skin contact – area of body contact – chemical physio-chemical properties– extent of dermal absorption.

Today’s Colloquium-Dermal Absorption and Toxicity: Concepts for Application to Safety Assessment, cont.

This colloquium will explore how different factors can affect the extent of dermal absorption.

A reasonable dermal estimate of human exposure can be calculated if the extent of skin absorption is realistically determined.

SOT- Dermal Toxicology Specialty Section

Dermal Toxicology Specialty Section (DTSS) Mission – DTSS provides a forum for the interaction of individuals

involved in risk assessment, pharmacokinetics, dermal penetration/ absorption, hypersensitivity and dermal toxicity, regulatory issues, basic skin biology, and other professionals working in the field of dermal research.

More information on DTSS:https://www.toxicology.org/groups/ss/DTSS/mission.asp

Welcome

Nancy Monteiro-Riviere, PhDColloquium Chair

Enjoy the Colloquium!

SOT FDA Organizing Committee