*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : RC9020000
CHEMICAL NAME : 19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-
mixed with 3-methoxy-19-nor-17-alpha-
pregna-1,3,5(10)-trien-20-yn-17-ol
CAS REGISTRY NUMBER : 8015-29-0
LAST UPDATED : 199612
DATA ITEMS CITED : 22
MOLECULAR FORMULA : C21-H26-O2.C20-H26-O2
MOLECULAR WEIGHT : 608.93
WISWESSER LINE NOTATION : L E5 B666TTT&J E1 FQ F1UU1 OO1 &L E5 B666 OV MUTJ E1
FQ F1UU1
COMPOUND DESCRIPTOR : Tumorigen
Drug
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* Ethynylestradiol 3-methyl ether and 17-alpha-ethynyl-19-nortestosterone
* 17-alpha-Ethynyl-17-hydroxyestren-3-one and ethynylestradiol 3-methyl
ether
* Ethynylestradiol 3-methyl ether and
17-alpha-ethynyl-17-hydroxyestren-3-one
* Ethynylestradiol methyl ether and norethindrone
* 17-alpha-Ethynyl-19-nortestosterone and ethynylestradiol 3-methyl ether
* Mestranol mixed with norethindrone
* Mestranol mixed with norethisterone
* Norethindrone and ethynylestradiol methyl ether
* Norethindrone mixed with mestranol
* Norethisterone mixed with mestranol
* Norinyl-1
* Ortho-novum
* Sophia
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 10 mg/kg/Y-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - dyspnea
Gastrointestinal - nausea or vomiting
Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,1479,1973
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1456 mg/kg/2Y-C
TOXIC EFFECTS :
Liver - changes in liver weight
Endocrine - changes in spleen weight
Related to Chronic Data - changes in testicular weight
REFERENCE :
PHMCAA Pharmacologist. (American Soc. for Pharmacology and Experimental
Therapeutics, 9650 Rockville Pike, Bethesda, MD 20014) V.1- 1959-
Volume(issue)/page/year: 4,176,1962
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 26460 ug/kg/5Y-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - tumors
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,310,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 5639 mg/kg/2Y-C
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Skin and Appendages - tumors
REFERENCE :
NAIZAM Nara Igaku Zasshi. Journal of the Nara Medical Association. (Nara
Igakkai, c/o Narakenritsu Ika Daigaku, Shijo-cho, Kashihara, Nara-ken,
Japan) V.1- 1950- Volume(issue)/page/year: 25,684,1974
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 40 mg/kg/4Y-I
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Liver - tumors
REFERENCE :
JAMAAP JAMA, Journal of the American Medical Association. (AMA, 535 N.
Dearborn St., Chicago, IL 60610) V.1- 1883- Volume(issue)/page/year:
235,730,1976
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 71 mg/kg/7Y-I
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Liver - tumors
REFERENCE :
ANSUA5 Annals of Surgery. (Lippincott/Harper, Journal Fulfillment Dept.,
2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1885-
Volume(issue)/page/year: 183,239,1976
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 53 mg/kg/7Y-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - tumors
Blood - thrombocytopenia
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,365,1980
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 4024 ug/kg
SEX/DURATION : female 20 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
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: 85,427,1963
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 : 21 mg/kg
SEX/DURATION : male 49 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
Reproductive - Paternal Effects - breast development
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 - woman
DOSE : 37 mg/kg
SEX/DURATION : female 6-26 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
71,128,1967
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 7665 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 :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 25,243,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1008 ug/kg
SEX/DURATION : female 20 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: 16,158,1965
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 12 mg/kg
SEX/DURATION : female 60 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 :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 16,158,1965
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 546 mg/kg
SEX/DURATION : male 13 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
Reproductive - Paternal Effects - testes, epididymis, sperm duct
REFERENCE :
NAIZAM Nara Igaku Zasshi. Journal of the Nara Medical Association. (Nara
Igakkai, c/o Narakenritsu Ika Daigaku, Shijo-cho, Kashihara, Nara-ken,
Japan) V.1- 1950- Volume(issue)/page/year: 25,684,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 455 mg/kg
SEX/DURATION : female 13 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
REFERENCE :
NAIZAM Nara Igaku Zasshi. Journal of the Nara Medical Association. (Nara
Igakkai, c/o Narakenritsu Ika Daigaku, Shijo-cho, Kashihara, Nara-ken,
Japan) V.1- 1950- Volume(issue)/page/year: 25,684,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 180 mg/kg
SEX/DURATION : male 4 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
NAIZAM Nara Igaku Zasshi. Journal of the Nara Medical Association. (Nara
Igakkai, c/o Narakenritsu Ika Daigaku, Shijo-cho, Kashihara, Nara-ken,
Japan) V.1- 1950- Volume(issue)/page/year: 26,489,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 150 mg/kg
SEX/DURATION : female 4 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
NAIZAM Nara Igaku Zasshi. Journal of the Nara Medical Association. (Nara
Igakkai, c/o Narakenritsu Ika Daigaku, Shijo-cho, Kashihara, Nara-ken,
Japan) V.1- 1950- Volume(issue)/page/year: 26,489,1975
*** REVIEWS ***
TOXICOLOGY REVIEW
CRTXB2 CRC Critical Reviews in Toxicology. (CRC Press, Inc., 2000 Corporate
Blvd., NW, Boca Raton, FL 33431) V.1- 1971- Volume(issue)/page/year:
1(1),93,1971
TOXICOLOGY REVIEW
COGYAK Clinical Obstetrics and Gynecology. (Lippincott/Harper, Journal
Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1958-
Volume(issue)/page/year: 16(4),37,1973
TOXICOLOGY REVIEW
JIMRBV Journal of International Medical Research. (Cambridge Medical Pub.
Ltd., 435/437 Wellingborough Rd., Northampton, NN1 4EZ, UK) V.1- 1972-
Volume(issue)/page/year: 1,141,1973
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
*** END OF RECORD ***