*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : RC8965000
CHEMICAL NAME : 19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-acetoxy-
CAS REGISTRY NUMBER : 51-98-9
BEILSTEIN REFERENCE NO. : 2064104
REFERENCE : 4-08-00-01221 (Beilstein Handbook Reference)
LAST UPDATED : 199612
DATA ITEMS CITED : 37
MOLECULAR FORMULA : C22-H28-O3
MOLECULAR WEIGHT : 340.50
WISWESSER LINE NOTATION : L E5 B666 OV MUTJ E1 FOV1 F1UU1 -B&EF
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* 17-Acetoxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
* 17-beta-Acetoxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
* (17-alpha)-17-(Acetyloxy)-19-norpregn-4-en-20-yn-3-one
* 17-Acetyloxy(17-alpha)-19-norpregn-4-estren-17-beta-ol-acetate-3-one
* ENTA
* 17-alpha-Ethinyl-19-nortestosterone acetate
* 17-alpha-Ethinyl-19-nortestosterone-17-beta-acetate
* 17-alpha-Ethynyl-17-beta-acetoxy-19-norandrost-4-en-3-one
* 17-alpha-Ethynyl-17-hydroxyestr-4-en-3-one acetate
* 17-alpha-Ethynyl-19-nortestosterone acetate
* 17-Hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one acetate
* 17-beta-Hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one acetate
* Milli-Anovlar
* Miniphase
* Norethindrone acetate
* Norethindrone 17-acetate
* Norethisteron acetate
* Norethisterone acetate
* 19-Norethisterone acetate
* Norethynyltestosterone acetate
* 19-Norethynyltestosterone acetate
* Norethysterone acetate
* Norlutate
* Norlutin A
* Norlutine acetate
* Orlutate
* Primolut-Nor
* Progylut
* SH 420
*** HEALTH HAZARD DATA ***
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 303 ug/kg/2Y-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Liver - tumors
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
JTEHD6 Journal of Toxicology and Environmental Health. (Hemisphere Pub.,
1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76-
Volume(issue)/page/year: 6,895,1980
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 2190 ug/kg
SEX/DURATION : female 52 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
2,730,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 2 mg/kg
SEX/DURATION : female 20 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
REFERENCE :
PRSMA4 Proceedings of the Royal Society of Medicine. (New York, NY) V.1-70,
1907-77. For publisher information, see JRSMD9. Volume(issue)/page/year:
53,435,1960
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1150 ug/kg
SEX/DURATION : female 23 day(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: 84,1470,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Human - woman
DOSE : 45 ug/kg
SEX/DURATION : lactating female 15 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 16,383,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Human - woman
DOSE : 366 ug/kg
SEX/DURATION : female 21 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 11,505,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 15 mg/kg
SEX/DURATION : female 13-30 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
OBGNAS Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1953- Volume(issue)/page/year:
22,210,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 12 mg/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 35,459,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1 mg/kg
SEX/DURATION : female 10 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - other neonatal measures or effects
REFERENCE :
JDGRAX Journal of Drug Research. (National Organization for Drug Research
and Control, POB 29, Cairo, Egypt) V.2- 1969- Volume(issue)/page/year:
9(1-2),129,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 6 mg/kg
SEX/DURATION : female 1-3 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
REFERENCE :
RPTOAN Russian Pharmacology and Toxicology (English Translation).
Translation of FATOAO. (Euromed Pub., 33, Woodlands Rd., Surbiton, Surrey,
UK) V.30- 1967- Volume(issue)/page/year: 43,2,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 408 mg/kg
SEX/DURATION : female 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
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: 108,3,1961
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 7 mg/kg
SEX/DURATION : female 14 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 24,284,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 1200 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 35,459,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 2800 ug/kg
SEX/DURATION : female 14 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 5,57,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 50 mg/kg
SEX/DURATION : female 15-24 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
BNEOBV Biology of the Neonate. (S. Karger Pub., Inc., 79 Fifth Ave., New
York, NY 10003) V.15- 1970- Volume(issue)/page/year: 24,57,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 150 mg/kg
SEX/DURATION : female 14-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
ENDOAO Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston
St., Baltimore, MD 21203) V.1- 1917- Volume(issue)/page/year:
71,448,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 55 mg/kg
SEX/DURATION : female 15-25 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - extra-embryonic structures
(e.g., placenta, umbilical cord)
Reproductive - Specific Developmental Abnormalities - homeostasis
REFERENCE :
BNEOBV Biology of the Neonate. (S. Karger Pub., Inc., 79 Fifth Ave., New
York, NY 10003) V.15- 1970- Volume(issue)/page/year: 24,57,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 60 mg/kg
SEX/DURATION : female 17-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
AVBIB9 Advances in the Biosciences. (Pergamon Press Inc., Maxwell House,
Fairview Park, Elmsford, NY 10523) V.1- 1967- Volume(issue)/page/year:
13,71,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 70 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: 5,57,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rat
DOSE : 7500 ug/kg
SEX/DURATION : female 1-3 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
STEDAM Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609)
V.1- 1963- Volume(issue)/page/year: 4,657,1964
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Rodent - rat
DOSE : 25800 ug/kg
SEX/DURATION : female 17 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 12,549,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - rat
DOSE : 2 ug/kg
SEX/DURATION : female 1 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
15TRAW "Preimplantation Stages of Pregnancy, Ciba Foundation Symposium,
London, 1965," Wolstenholme, G.E.W., and M. O'Connor, eds., Boston, Little,
Brown and Co., 1965 Volume(issue)/page/year: -,378,1965
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 80 mg/kg
SEX/DURATION : female 16-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
OBGNAS Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1953- Volume(issue)/page/year:
23,359,1964
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 20 mg/kg
SEX/DURATION : female 1-4 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 21,537,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 4 mg/kg
SEX/DURATION : female 5 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: 12,529,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 3 mg/kg
SEX/DURATION : female 3 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
ENDOAO Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston
St., Baltimore, MD 21203) V.1- 1917- Volume(issue)/page/year:
81,1251,1967
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 125 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
IJPAAO Indian Journal of Pharmacy. (Bombay, India) V.1-40(1), 1939-78. For
publisher information, see IJSIDW. Volume(issue)/page/year: 35,100,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Rodent - rabbit
DOSE : 7500 ug/kg
SEX/DURATION : female 17 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 12,549,1975
** MUTATION DATA **
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 1 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 367,1,1996
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 1 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 367,1,1996
TYPE OF TEST : Micronucleus test
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 1 mg/kg
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 367,1,1996
TYPE OF TEST : Sister chromatid exchange
ROUTE OF EXPOSURE : Parenteral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 1 mg/kg
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 367,1,1996
TYPE OF TEST : Dominant lethal test
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 1120 mg/kg/4W
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 26,535,1974
TYPE OF TEST : Sex chromosome loss and nondisjunction
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 11200 mg/kg/4W
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 26,535,1974
*** REVIEWS ***
IARC Cancer Review:Animal Sufficient Evidence
IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49
Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year:
7,294,1987
TOXICOLOGY REVIEW
CMROCX Current Medical Research and Opinion. (Clayton-Wray Pub. Ltd., 1a
High St., Alton, Hants., UK) V.1- 1972- Volume(issue)/page/year:
4,309,1976
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Inconclusive: Rodent dominant lethal
*** END OF RECORD ***