Skip to main content

Table 7 Division of the developmental toxicity data set according to the FDA Guidelines and CAESAR binary classes

From: CAESAR models for developmental toxicity

FDA classes

Definition

CAESAR Binary class

Total compounds

Category A

Negative human studies

  

Category B

Negative animal studies

  
 

No human studies executed

Non-developmental toxicant

91

 

OR

  
 

Positive animal studies

  
 

Negative human studies

  

Category C

Positive animal studies

  
 

No human studies executed

  
 

OR

  
 

No studies at all

  

Category D

Positive human studies

Developmental toxicant

201

Category X

Animal OR human studies show abnormalities

  
 

AND/OR

  
 

Evidence of fetal risk based on human experience

  
   

292