Module 14 2022

21/03/2022

Biological Evaluation

Toxicity Endpoints

• Systemic Toxicity – where absorption likely

• Sub-acute and Sub-chronic toxicity - Applicable when single or multiple exposures occur >24 h

• Genotoxicity - Mutations, damage to chromosomes

The Organisation for Professionals in Regulatory Affairs

15

Biological Evaluation

Supplementary tests

• Chronic toxicity • Carcinogenicity • Reproductive and developmental toxicity

• Biodegradation • Immunotoxicity • Toxicokinetics

The Organisation for Professionals in Regulatory Affairs

16

8