*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : JF8300000
CHEMICAL NAME : 18,19-Dinorpregn-4-en-20-yn-3-one,
13-ethyl-17-hydroxy-, (17-alpha)-(+-)-, mixt. with
(17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-d
iol
CAS REGISTRY NUMBER : 8056-51-7
OTHER CAS REGISTRY NOS. : 70208-30-9
8064-50-4
8063-84-1
LAST UPDATED : 199712
DATA ITEMS CITED : 16
MOLECULAR FORMULA : C21-H28-O2.C20-H24-O2
MOLECULAR WEIGHT : 608.93
COMPOUND DESCRIPTOR : Tumorigen
Drug
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* Biphasil
* Duoluton
* Ediwal
* Ethinyl estradiol mixed with norgestrel
* Ethinylestradiol mixed with dl-norgestrel
* Ethinyloestradiol mixed with norgestrel
* Eugynon
* Eugynon 30
* Femenal
* Follimin
* Follinett
* Follinyl
* Gravistat
* Lo-Femenal
* LO/Ovral
* Microgynon
* Microvlar 30
* Minidril
* Neogynon
* Neovletta
* Nordiol
* Nordiol-28
* Norgestrel-ethynylestradiol mixt.
* Norgestrel mixed with ethinyl estradiol
* dl-Norgestrel mixed with ethinylestradiol
* Norgestrel mixed with ethinyloestradiol
* Orasecron
* Ovidon
* Ovral
* Ovral 21
* Ovral 28
* Ovral L
* Ovran
* Ovranett
* Primovlar
* Pro-Duosterone
* Rigevidon
* Sequilar
* Sequilarum
* Sequostat
* SH 71121
* SHB 261AB
* SHB 264AB
* Stediril
* Stediril D
* Triquilar
* WL 20
* WL 33
* WY-E 104
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,567,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >5500 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,567,1982
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 18144 ug/kg/12Y-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: 1,273,1980
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 5 mg/kg/26W-I
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Liver - tumors
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 2,926,1973
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 756 ug/kg/26W-I
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Liver - tumors
REFERENCE :
MJAUAJ Medical Journal of Australia. (Australasian Medical Pub. Co. Ltd.,
71-79 Arundel St., Glebe, N.S.W., Australia) V.1- 1914-
Volume(issue)/page/year: 2,223,1978
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 50 mg/kg/5Y-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic 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
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 308 ug/kg
SEX/DURATION : lactating female 28 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
REFERENCE :
IJMRAQ Indian Journal of Medical Research. (Indian Council of Medical
Research, Ansari Nagar, New Delhi 110 029, India) V.1- 1913-
Volume(issue)/page/year: 62,964,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 220 ug/kg
SEX/DURATION : female 20 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 26,23,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 3 mg/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 :
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: 108,183,1970
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1966 ug/kg
SEX/DURATION : female 26 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: 10,127,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 44 ug/kg
SEX/DURATION : female 1 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 :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 37,508,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 44 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 32,297,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1050 ug/kg
SEX/DURATION : female 35 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - mating performance (e.g. # sperm positive females
per # females mated; # copulations per # estrus cycles)
REFERENCE :
INJFA3 International Journal of Fertility. (Allen Press, 1041 New
Hampshire, St., Lawrence, KS 66044) V.1- 1955- Volume(issue)/page/year:
11,389,1966
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 8750 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 :
INJFA3 International Journal of Fertility. (Allen Press, 1041 New
Hampshire, St., Lawrence, KS 66044) V.1- 1955- Volume(issue)/page/year:
11,389,1966
*** REVIEWS ***
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
TOXICOLOGY REVIEW
TJADAB Teratology, The International Journal of Abnormal Development. (Alan
R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
Volume(issue)/page/year: 21,225,1980
*** END OF RECORD ***