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. 2010 Jul 29;4(Suppl 1):S4. doi: 10.1186/1752-153X-4-S1-S4

Table 7.

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

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