Nimodipine: Chemical Meeting the Criteria for Listing as Causing Reproductive Toxicity via the "Formally Required to be Labeled or Identified" Mechanism (Package 19b.2)

Feb 23, 2001

The chemical in the table below meets the requirements outlined in Title 22, California Code of Regulations, Section 12902 for the listing of a chemical that a state or federal agency has formally required to be labeled or identified as causing cancer or reproductive toxicity.

According to Title 22 CCR Section 12902,

" ‘labeled’ means that a warning message about the carcinogenicity or reproductive toxicity of a chemical is printed, stamped, written, or in any other manner placed upon the container in which the chemical is present or its outer or inner packaging including any material inserted with, attached to, or otherwise accompanying such a chemical;"
" ‘identified’ means that a required message about the carcinogenicity or reproductive toxicity of the chemical is to be disclosed in any manner to a person or legal entity other than the person or legal entity who is required to make such disclosure"; and
"as causing cancer or reproductive toxicity" means: "For chemicals that cause cancer, the required label or identification uses any words or phrases intended to communicate a risk of cancer or tumors." "For chemicals that cause reproductive toxicity, the required label or identification uses any words or phrases intended to communicate a risk of reproductive harm to men or women or both, or a risk of birth defects or other developmental harm."

The chemical in the table below has been identified or labeled to communicate a risk of reproductive or developmental harm, in accordance with formal requirements by the U.S. Food and Drug Administration (FDA). Following the table, language taken directly from the FDA-approved product label that meets the requirements outlined in Title 22 CCR Section 12902 is quoted.

Chemical	CAS No.	Toxicological Endpoints	References
Nimodipine	66085-59-4	Developmental toxicity	FDA (1996)

Nimodipine (Under PRECAUTIONS)

Pregnancy. Pregnancy Category C. "Nimodipine has been shown to have a teratogenic effect in Himalayan rabbits. Incidences of malformations and stunted fetuses were increased at oral doses of 1 and 10 mg/kg/day (administered by gavage) from day 6 through day 18 of pregnancy but not at 3.0 mg/kg/day in one of two identical rabbit studies. In the second study an increased incidence of stunted fetuses was seen at 1.0 mg/kg/day but not at higher doses. Nimodipine was embryotoxic, causing resorption and stunted growth of fetuses, in Long Evans rats at 100 mg/kg/day administered by gavage from day 6 through day 15 of pregnancy. In two other rat studies, doses of 30 mg/kg/day nimodipine administered by gavage from day 16 of gestation and continued until sacrifice (day 20 of pregnancy or day 21 post partum) were associated with higher incidences of skeletal variation, stunted fetuses and stillbirths but no malformations. There are no adequate and well controlled studies in pregnant women to directly assess the effect on human fetuses. Nimodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."