Results of Teratogenicity Testing of m-Aminophenol in Sprague-Dawley Rats

Results of Teratogenicity Testing of m-Aminophenol in Sprague-DawleyRats. RE, T. A., LOEHR, R. F., RODRIGUEZ, S. C., RODWELL, D.E., AND BURNETT, C. M. (1984). Fundam. Appl. Toxicol. 4, 98–104.meta-Aminophenol (m-AP) was administered in the diet to femaleSprague-Dawley rats for a period of at least 90 days at levelsof 0.1, 0.25, and 1.0%. In the 0.25% group a significant reductionin body weight was noted, in comparison with control values,and in the 1.0% group a significant reduction in both body weightand food consumption was noted. Ten of the rats in each groupwere necropsied. Deposition of iron positive pigment in thespleen, liver, and kidney combined with decreased red bloodcell count and hemoglobin and increased mean corpuscular volumeindicated a hemolytic effect. There were also morphologic changesin the thyroid which were consistent with hyperactivity. Theremaining 25 rats in each group were removed from m-AP treatmentand immediately mated to untreated males of the same strain.After the mating period the dams again were given m-AP for theduration of gestation. All dams were killed on Day 20 of gestation;one-third of the fetuses were examined for visceral malformationsand two-thirds for skeletal malformations and variations. Anadditional significant reduction in body weight gain was notedduring gestation in the 1.0% group as compared to the controlgroup. There were no other adverse dose-related findings demonstratedin the reproduction performance of the dams or in the survivalor development of their offspring. Therefore, although maternaltoxicity was demonstrated at the highest dose level, there wasno evidence of teratogenic or embryofetal toxicity at any doselevel tested.