Reproductive/developmental toxicity studies

Tri-o-cresyl phosphate, not classified as a pesticide, is the only organophosphate for which testing and a final report were to have been completed in 1986. One of the TOCP studies under the auspices of CDC/NIOSH, and with an A completion priority, was a reproductive/developmental toxicity study. However, it is unclear from the TOCP listings (ref. 172a, Table 23) whether either the reproductive study or one of the neurologic/behavioral studies for TOCP was completed and reported in 1986. 

Rodent reproductive/developmental toxicity study (segment 2) 14... 

Review of the reproductive/developmental toxicity studies that have been conducted in support of the approved biopharmaceuticals have shown that historically a flexible case-by-case approach has been applied. For biopharmaceuticals that cross-react only with nonhuman primates a limited reproductive toxicity testing strategy has been employed based on the patient population, the indication, and the proposed clinical use. The studies that have been performed have been sufficient to inform the patient populations of potential risk to the fetus. 

Note 2 There may be extensive public information available regarding potential reproductive and/or developmental effects of a particular class of compounds (e.g., interferons) where the only relevant species is the non-human primate. In such cases, mechanistic studies indicating that similar effects are likely to be caused by a new but related molecule, may obviate the need for formal reproductive/developmental toxicity studies. In each case, the scientific basis for assessing the potential for possible effects on reproduction/development should be provided. 

---