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Repeated dose (28 days) oral toxicity study of flutamide in rats, based on the draft protocol for the 'Enhanced OECD Test Guideline 407' for screening for endocrine-disrupting chemicals. 2000

K Toyoda, and M Shibutani, and T Tamura, and T Koujitani, and C Uneyama, and M Hirose
Division of Pathology, National Institute of Health Sciences, Tokyo, Japan.

In association with the international validation project to establish a test protocol for the 'Enhanced OECD Test Guideline 407', we performed a preliminary 28-day, repeated-dose toxicity study of flutamide, a non-steroidal androgen antagonist, and assessed the sensitivity of a list of parameters for detecting endocrine-related effects of endocrine-disrupting chemicals (EDCs). Seven-week-old CD(SD)IGS rats were divided into four groups, each consisting of 10 males and 10 females, and administered flutamide once daily by oral gavage at doses of 0 (control), 0.25, 1 and 4 mg/kg body weight/day. Male rats were killed 1 day after the 28th administration. Female rats were killed on the day they entered the diestrus stage in the estrous cycle following the last treatment. Male rats receiving flutamide at dose levels of 1 and 4 mg/kg showed lobular atrophy of the mammary gland and a decrease in epididymal weight. In addition, 4 mg/kg flutamide-treated males exhibited raised serum testosterone and estradiol levels and decreased weight of the accessory sex glands. In females, a slight prolongation of the estrous cycle was also observed in the 4 mg/kg flutamide-treated group. No dose-related changes could be detected by haematology, serum biochemistry and sperm analysis. Thus, among the parameters tested in the present experimental system, the weight of endocrine-linked organs and their histopathological assessment, serum hormone levels, and estrous cycle stage allowed the detection of endocrine-related effects of flutamide.

UI MeSH Term Description Entries
D008297 Male Males
D009929 Organ Size The measurement of an organ in volume, mass, or heaviness. Organ Volume,Organ Weight,Size, Organ,Weight, Organ
D004822 Epididymis The convoluted cordlike structure attached to the posterior of the TESTIS. Epididymis consists of the head (caput), the body (corpus), and the tail (cauda). A network of ducts leaving the testis joins into a common epididymal tubule proper which provides the transport, storage, and maturation of SPERMATOZOA.
D004971 Estrus The period in the ESTROUS CYCLE associated with maximum sexual receptivity and fertility in non-primate female mammals.
D005260 Female Females
D005485 Flutamide An antiandrogen with about the same potency as cyproterone in rodent and canine species. Niftolid,Apimid,Apo-Flutamide,Chimax,Cytamid,Drogenil,Euflex,Eulexin,Eulexine,Fluken,Flulem,Flumid,Fluta 1A Pharma,Fluta-GRY,Fluta-cell,Flutamin,Flutandrona,Flutaplex,Flutexin,Fugerel,Grisetin,Niftolide,Novo-Flutamide,Oncosal,PMS-Flutamide,Prostacur,Prostica,Prostogenat,SCH-13521,Testotard,Apo Flutamide,ApoFlutamide,Fluta GRY,Fluta cell,FlutaGRY,Flutacell,Novo Flutamide,NovoFlutamide,PMS Flutamide,SCH 13521,SCH13521
D006727 Hormone Antagonists Chemical substances which inhibit the function of the endocrine glands, the biosynthesis of their secreted hormones, or the action of hormones upon their specific sites. Antagonists, Hormone
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000726 Androgen Antagonists Compounds which inhibit or antagonize the biosynthesis or actions of androgens. Androgen Antagonist,Antiandrogen,Antiandrogens,Anti-Androgen Effect,Anti-Androgen Effects,Antiandrogen Effect,Antiandrogen Effects,Antagonist, Androgen,Antagonists, Androgen,Anti Androgen Effect,Anti Androgen Effects,Effect, Anti-Androgen,Effect, Antiandrogen,Effects, Anti-Androgen,Effects, Antiandrogen
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia

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