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 | |||