*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : BV8060000
CHEMICAL NAME : 5-alpha,17-beta-Androstan-3-one,
17-hydroxy-2-(hydroxymethylene)-17-methyl-
CAS REGISTRY NUMBER : 434-07-1
LAST UPDATED : 199712
DATA ITEMS CITED : 19
MOLECULAR FORMULA : C21-H32-O3
MOLECULAR WEIGHT : 332.53
WISWESSER LINE NOTATION : L E5 B666 OVTJ A1 E1 FQ F1 P1Q
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* Adroidin
* Adroyd
* Anadrol
* Anadroyd
* Anapolon
* Anasteron
* Anasteronal
* Anasterone
* Androstan-3-one, 17-hydroxy-2-(hydroxymethylene)-17-methyl-,
(5-alpha,17-beta)-
* 5-alpha-Androstan-3-one, 17-beta-hydroxy-2-(hydroxymethylene)-17-methyl-
* Androstano(2,3-c)(1,2,5)oxadiazol-17-ol, 17-methyl-, (5-alpha,17-beta)-
* Becorel
* CI-406
* 4,5-Dihydro-2-hydroxymethylene-17-alpha-methyltestosterone
* Dynasten
* HMD
* 17-Hydroxy-2-(hydroxymethylene)-17-methyl-5-alpha-17-beta-androst-3-one
* 17-beta-Hydroxy-2-hydroxymethylene-17-alpha-methyl-3-androstanone
* 17-beta-Hydroxy-2-(hydroxymethylene)-17-alpha-methyl-5-alpha-androstan-3
-one
* 17-beta-Hydroxy-2-(hydroxymethylene)-17-methyl-5-alpha-androstan-3-one
* 2-Hydroxymethylene-17-alpha-methyl-5-alpha-androstan-17-beta-ol-3-one
* 2-Hydroxymethylene-17-alpha-methyl-dihydrotestosterone
* 2-(Hydroxymethylene)-17-alpha-methyldihydrotestosterone
* 2-Hydroxymethylene-17-alpha-methyl-17-beta-hydroxy-3-androstanone
* Methabol
* 17-alpha-Methyl-2-hydroxymethylene-17-hydroxy-5-alpha-androstan-3-one
* Nastenon
* NSC-26,198
* Oximetholonum
* Oximetolona
* Oxitosona-50
* Oxymethalone
* Oxymethenolone
* Oxymetholone
* Pavisoid
* Plenastril
* Protanabol
* Roboral
* Synasteron
* Zenalosyn
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human
DOSE/DURATION : 46 mg/kg/14W-I
TOXIC EFFECTS :
Liver - liver function tests impaired
REFERENCE :
JAMAAP JAMA, Journal of the American Medical Association. (AMA, 535 N.
Dearborn St., Chicago, IL 60610) V.1- 1883- Volume(issue)/page/year:
240,243,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >1 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: 6,156,1982
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 5200 mg/kg/13W-I
TOXIC EFFECTS :
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Blood - changes in other cell count (unspecified)
Blood - changes in erythrocyte (RBC) count
REFERENCE :
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
Akron, OH 44311) V.1- 1981- Volume(issue)/page/year: 13,381,1993
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 270 mg/kg/9W-C
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - tumors
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
296,1411,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 2336 mg/kg/2Y-C
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - jaundice (or hyperbilirubinemia) hepatocellular
Liver - tumors
REFERENCE :
CANCAR Cancer (Philadelphia). (Lippincott/Harper, Journal Fulfillment
Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1948-
Volume(issue)/page/year: 43,440,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - child
DOSE/DURATION : 3050 mg/kg/3Y-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - tumors
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
87,122,1975
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 3735 mg/kg/3Y-C
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: 2,1273,1972
** REPRODUCTIVE DATA **
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 : 128 mg/kg
SEX/DURATION : male 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
JJPAAZ Japanese Journal of Pharmacology. (Japanese Pharmacological Soc.,
c/o Dept. of Pharmacology, Faculty of Medicine, Kyoto Univ., Sakyo-ku, Kyoto
606, Japan) V.1- 1951- Volume(issue)/page/year: 24,551,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 150 mg/kg
SEX/DURATION : female 7-12 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
REFERENCE :
STEDAM Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609)
V.1- 1963- Volume(issue)/page/year: 18,731,1971
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 28 mg/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 : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 30 mg/kg
SEX/DURATION : female 1-3 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 :
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: 117,167,1973
** MUTATION DATA **
TYPE OF TEST : Micronucleus test
TEST SYSTEM : Rodent - hamster Embryo
DOSE/DURATION : 10 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 392,61,1997
*** REVIEWS ***
IARC Cancer Review:Animal No Adequate Data
IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49
Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year:
7,96,1987
TOXICOLOGY REVIEW
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
8,259,1973
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X6172
No. of Facilities: 28 (estimated)
No. of Industries: 1
No. of Occupations: 1
No. of Employees: 742 (estimated)
No. of Female Employees: 359 (estimated)
*** STATUS IN U.S. ***
NTP 7th Annual Report on Carcinogens, 1992 : anticipated to be carcinogen
NTP Carcinogenesis studies; on test (two year studies), October 1997
*** END OF RECORD ***