Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Inhalation. Ingestion.
Toxicity to Animals: oral toxicity (LD50): 56.6 mg/kg [Rat]. 63.1 mg/kg [Mouse].   
Listed as a carcinogen by : NTP : No IRAC : No OSHA : No.
Corrosivity : n/f
Sensitization Data : n/f
Other Carcinogenicity Data: There were statistically significant increases in pituitary gland adenomas, endocrine pancreas adenomas, and mammary gland adenocarcinomas in mice and rats administered oral risperidone at doses of 0.63, 2.5 and 10mg/kg for 18 months and 25 months, respectively.
Mutagenicity Data : Risperidone was not mutagenic in the Ames reverse mutation test, mouse lymphoma assay, in vitro rat hepatocyte DNA-repair assay, in vivo micronucleus test in mice, the sex-linked recessive lethal test in Drosophila, or the chromosomal aberration test in human lymphocytes or Chinese hamster cells.
Reproductive and Developmental Effects : Risperidone was shown to impair mating, but not fertility, in rats given 0.16 to 5 mg/kg and the effect appeared to be in females. In dogs administered doses of 0.31 to 5 mg/kg, sperm motility and concentration were decreased and dose-related decreases in serum testosterone levels were noted. The incidence of birth defects was not increased in rats and rabbits given risperidone doses upto 10mg/kg and 5 mg/kg, respectively. In other rat studies, there was an increase in stillborn pups at 2.5 mg/kg, some decrease in fetal weight at 10 mg/kg, and an increase in pup deaths during lactation at doses up to 5 mg/kg. it is not known if these pup deaths were due to direct effect on the fetus or pups or effects on the mothers.