*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : RC8990000
CHEMICAL NAME : 19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-,
acetate mixed with 19-nor-17-alpha-
pregna-1,3,5-(10)-trien-20-yne-3,17-diol
CAS REGISTRY NUMBER : 8015-12-1
LAST UPDATED : 199706
DATA ITEMS CITED : 21
MOLECULAR FORMULA : C22-H28-O3.C20-H24-O2
MOLECULAR WEIGHT : 636.94
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* Anovlar 21
* Controvlar
* Ethinylestradiol and norethindrone acetate
* Ethinyl oestradiol mixed with norethisterone acetate
* Gyn-Anovlar
* Gynonlar 21
* Minovlar
* Norethindrone acetate and ethinylestradiol
* Norethisterone acetate mixed with ethinyl oestradiol
* Norlestrin
* Primodos
*** HEALTH HAZARD DATA ***
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 23562 ug/kg/94W-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Lungs, Thorax, or Respiration - tumors
Liver - tumors
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,207,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 11087 mg/kg/1Y-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Liver - tumors
REFERENCE :
KNZOAU Kanzo. Liver. (Nippon Kanzo Gakkai, c/o Kikka Bldg., 4-1-1 Hongo,
Bunkyo-ku, Tokyo 113, Japan) V.1- 1960- Volume(issue)/page/year:
23,57,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 69 mg/kg/69W-I
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Skin and Appendages - tumors
Blood - leukemia
REFERENCE :
PEXTAR Progress in Experimental Tumor Research. (S. Karger AG, Postfach
CH-4009 Basel, Switzerland) V.1- 1960- Volume(issue)/page/year:
11,440,1969
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 41 mg/kg/2Y-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 : Rodent - rat
DOSE/DURATION : 22174 mg/kg/1Y-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Liver - tumors
REFERENCE :
KNZOAU Kanzo. Liver. (Nippon Kanzo Gakkai, c/o Kikka Bldg., 4-1-1 Hongo,
Bunkyo-ku, Tokyo 113, Japan) V.1- 1960- Volume(issue)/page/year:
23,57,1982
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 81 mg/kg/8Y-I
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Liver - tumors
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
3,7,1974
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 11087 mg/kg/1Y-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Liver - tumors
REFERENCE :
GANNA2 Gann. Japanese Journal of Cancer Research. (Tokyo, Japan) V.1-75,
1907-84. For publisher information, see JJCREP. Volume(issue)/page/year:
71,576,1980
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1176 ug/kg
SEX/DURATION : lactating female 56 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 : 420 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 : 214 ug/kg
SEX/DURATION : female 20 day(s) pre-mating
TOXIC EFFECTS :
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: 25,463,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 9720 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 :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
2,75,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1620 ug/kg
SEX/DURATION : female 20 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 :
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: 4,229,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 401 ug/kg
SEX/DURATION : female 5 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
REFERENCE :
NATUAS Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736)
V.1- 1869- Volume(issue)/page/year: 216,83,1967
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 14280 ug/kg
SEX/DURATION : female 33-46 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
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: 21,44A,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 15300 ug/kg
SEX/DURATION : female 21-35 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
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: 27,215,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 24 mg/kg
SEX/DURATION : female 23-46 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - behavioral
REFERENCE :
NTOTDY Neurobehavioral Toxicology and Teratology. (Fayetteville, NY) V.3-8,
1981-86. For publisher information, see NETEEC. Volume(issue)/page/year:
5,301,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 621 mg/kg
SEX/DURATION : female 20-50 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
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: 35,119,1987
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 1864 mg/kg
SEX/DURATION : female 20-50 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
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: 35,119,1987
** MUTATION DATA **
TYPE OF TEST : Cytogenetic analysis
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 12 mg/kg/15D (Continuous)
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 260,47,1991
*** REVIEWS ***
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
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Negative: Rodent dominant lethal
*** END OF RECORD ***