*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : RC8961200 CHEMICAL NAME : 19-Nor-17-alpha-pregn-4-en-3-one, 17-hydroxy- CAS REGISTRY NUMBER : 52-78-8 LAST UPDATED : 199606 DATA ITEMS CITED : 27 MOLECULAR FORMULA : C20-H30-O2 MOLECULAR WEIGHT : 302.50 WISWESSER LINE NOTATION : L E5 B666 OV MUTJ E1 FQ COMPOUND DESCRIPTOR : Mutagen Reproductive Effector Human Hormone SYNONYMS/TRADE NAMES : * 8022 C.B. * 17-ENT * 17-alpha-Ethyl-17-hydroxynorandrostenone * 17-alpha-Ethyl-17-hydroxy-4-norandrosten-3-one * 17-alpha-Ethyl-17-hydroxy-19-norandrost-4-en-3-one * 17-Ethyl-19-nortestosterone * 17-alpha-Ethyl-19-nortestosterone * 17-Hydroxy-19-norpregn-4-en-3-one * 17-Hydroxy-19-nor-17-alpha-pregn-4-en-3-one * 17-beta-Hydroxy-19-nor-17-alpha-pregn-4-en-3-one * (17-alpha)-17-Hydroxy-19-norpregn-4-en-3-one * Nileva * Nilevar * Norethandrolone * 19-Norethyltestosterone * 19-Nor-17-alpha-ethyltestosterone * 19-Norpregn-4-en-3-one, 17-hydroxy-, (17-alpha)- * 17-alpha-Nortestosterone * Pronabol * SC 5914 * Solevar * U 6817 *** HEALTH HAZARD DATA *** ** REPRODUCTIVE DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - man DOSE : 24 mg/kg SEX/DURATION : male 56 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) REFERENCE : ANYAA9 Annals of the New York Academy of Sciences. (New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877- Volume(issue)/page/year: 71,649,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - man DOSE : 9 mg/kg SEX/DURATION : male 21 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - impotence REFERENCE : ANYAA9 Annals of the New York Academy of Sciences. (New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877- Volume(issue)/page/year: 71,649,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - man DOSE : 174 mg/kg SEX/DURATION : male 58 week(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) REFERENCE : RPHRA6 Recent Progress In Hormone Research. Proceedings of the Laurentian Hormone Conference. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1947- Volume(issue)/page/year: 20,545,1964 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE : 64 mg/kg SEX/DURATION : female 64 week(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - other measures of fertility REFERENCE : AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920- Volume(issue)/page/year: 75,82,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - man DOSE : 24 mg/kg SEX/DURATION : male 56 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - testes, epididymis, sperm duct Reproductive - Paternal Effects - impotence REFERENCE : FEPRA7 Federation Proceedings, Federation of American Societies for Experimental Biology. (Bethesda, MD) V.1-46, 1942-87. Volume(issue)/page/year: 18,1057,1959 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - man DOSE : 12 mg/kg SEX/DURATION : male 28 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) REFERENCE : FEPRA7 Federation Proceedings, Federation of American Societies for Experimental Biology. (Bethesda, MD) V.1-46, 1942-87. Volume(issue)/page/year: 18,1057,1959 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE : 4200 ug/kg SEX/DURATION : female 21 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - other measures of fertility REFERENCE : SCIEAS Science. (American Assoc. for the Advancement of Science, 1333 H St., NW, Washington, DC 20005) V.1- 1895- Volume(issue)/page/year: 124,891,1956 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE : 13 mg/kg SEX/DURATION : female 21 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - menstrual cycle changes or disorders REFERENCE : AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920- Volume(issue)/page/year: 76,626,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 20 mg/kg SEX/DURATION : female 17-20 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - urogenital system REFERENCE : ECJPAE Endocrinologia Japonica. (Japan Pub. Trading Co., Ltd., POB 5030, Tokyo International, Tokyo, Japan) V.1- 1954- Volume(issue)/page/year: 24,77,1977 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 28 mg/kg SEX/DURATION : male 14 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland, accessory glands REFERENCE : ANYAA9 Annals of the New York Academy of Sciences. (New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877- Volume(issue)/page/year: 71,500,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 112 mg/kg SEX/DURATION : male 14 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - testes, epididymis, sperm duct REFERENCE : ANYAA9 Annals of the New York Academy of Sciences. (New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877- Volume(issue)/page/year: 71,500,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 100 mg/kg SEX/DURATION : female 4 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated) REFERENCE : ENDOAO Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917- Volume(issue)/page/year: 59,695,1956 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 15750 ug/kg SEX/DURATION : male 21 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - testes, epididymis, sperm duct Reproductive - Paternal Effects - other effects on male REFERENCE : PSEBAA Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- Volume(issue)/page/year: 119,340,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 200 ug/kg SEX/DURATION : female 17-20 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - urogenital system REFERENCE : ECJPAE Endocrinologia Japonica. (Japan Pub. Trading Co., Ltd., POB 5030, Tokyo International, Tokyo, Japan) V.1- 1954- Volume(issue)/page/year: 22,439,1975 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 3500 ug/kg SEX/DURATION : female 35 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated) REFERENCE : ENDOAO Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917- Volume(issue)/page/year: 63,561,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 60 mg/kg SEX/DURATION : male 30 day(s) pre-mating TOXIC EFFECTS : Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) Reproductive - Paternal Effects - testes, epididymis, sperm duct Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland, accessory glands REFERENCE : AAMMAU Archives d'Anatomie Microscopique et de Morphologie Experimentale. (SPPIF, B.P.22, F-41353 Vineuil, France) V.36-76, 1947-1987. For publisher information, see BSTME2. Volume(issue)/page/year: 48,199,1959 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 1400 ug/kg SEX/DURATION : female 14 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - ovaries, fallopian tubes Reproductive - Fertility - other measures of fertility REFERENCE : CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970- Volume(issue)/page/year: 5,489,1972 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 14 mg/kg SEX/DURATION : female 14 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina REFERENCE : CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970- Volume(issue)/page/year: 5,489,1972 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Unreported SPECIES OBSERVED : Rodent - rat DOSE : 150 mg/kg SEX/DURATION : female 30 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina REFERENCE : RPHRA6 Recent Progress In Hormone Research. Proceedings of the Laurentian Hormone Conference. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1947- Volume(issue)/page/year: 20,395,1964 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE : 1600 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina REFERENCE : 85GRAA "The Control of Fertility," Pincus, G., New York, Academic Press, 1965 Volume(issue)/page/year: -,150,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE : 320 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina REFERENCE : 85GRAA "The Control of Fertility," Pincus, G., New York, Academic Press, 1965 Volume(issue)/page/year: -,150,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rabbit DOSE : 1500 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - other measures of fertility REFERENCE : 85GRAA "The Control of Fertility," Pincus, G., New York, Academic Press, 1965 Volume(issue)/page/year: -,57,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rabbit DOSE : 2500 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - other measures of fertility REFERENCE : 13OPAL "Control of Ovulation, Proceedings of the Conference, Dedham, MA, 1960," Villee, C.A., ed., Oxford, UK, Pergamon Press Ltd., 1961 Volume(issue)/page/year: -,37,1961 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rabbit DOSE : 200 ug/kg SEX/DURATION : female 5 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina REFERENCE : ANREAK Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08- Volume(issue)/page/year: 142,469,1962 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rabbit DOSE : 100 ug/kg SEX/DURATION : female 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - other measures of fertility REFERENCE : 13OPAL "Control of Ovulation, Proceedings of the Conference, Dedham, MA, 1960," Villee, C.A., ed., Oxford, UK, Pergamon Press Ltd., 1961 Volume(issue)/page/year: -,37,1961 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - guinea pig DOSE : 168 mg/kg SEX/DURATION : female 42 day(s) pre-mating TOXIC EFFECTS : Reproductive - Maternal Effects - menstrual cycle changes or disorders Reproductive - Fertility - other measures of fertility REFERENCE : JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- Volume(issue)/page/year: 12,489,1966 *** STATUS IN U.S. *** EPA GENETOX PROGRAM 1988, Positive: Sperm morphology-human *** END OF RECORD ***