Module 18 2021

08/02/2021

Biological Evaluation

 Assess all available information  Assess required toxicological information  Identify gaps

The Organisation for Professionals in Regulatory Affairs

27

Assess Available Information

 Weight of Evidence Approach

● Physicochemical properties: is it likely to penetrate skin? ● Are there any epidemiological data? ● Is it a pharmaceutical ingredient, cosmetic ingredient or food additive? ● Do closely similar substances exist for which there are data? – “Read-Across”

The Organisation for Professionals in Regulatory Affairs

28

14