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Oraviron

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*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER : BV8400000
CHEMICAL NAME : Androst-4-en-3-one, 17-beta-hydroxy-17-methyl-
CAS REGISTRY NUMBER : 58-18-4
BEILSTEIN REFERENCE NO. : 2057425
REFERENCE : 4-08-00-01010 (Beilstein Handbook Reference)
LAST UPDATED : 199707
DATA ITEMS CITED : 36
MOLECULAR FORMULA : C20-H30-O2
MOLECULAR WEIGHT : 302.50
WISWESSER LINE NOTATION : L E5 B666 OV MUTJ A E FQ F -B&AEF
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :

  • Andrometh

  • Androsan (tablets)

  • 4-Androstene-17-alpha-methyl-17-beta-ol-3-one

  • Androst-4-en-3-one, 17-hydroxy-17-methyl-, (17-beta)-

  • Anertan (tablets)

  • Glosso sterandryl

  • Homandren

  • Hormale

  • 17-beta-Hydroxy-17-methylandrost-4-en-3-one

  • Malestrone

  • Malogen

  • Mastestona

  • Metandren

  • 17-Methyltestosteron

  • 17-Methyltestosterone

  • 17-alpha-Methyltestosterone

  • Metrone

  • M.T.Mucorettes

  • Nabolin

  • NSC-9701

  • Nu-man

  • Oraviron

  • Oreton-M

  • Oreton methyl

  • RU 24400

  • Steronyl

  • Synandrets

  • Synandrotabs

  • Testhormone

  • Testora

  • Testoviron (tablet)

                  *** HEALTH HAZARD DATA ***
    
                   ** ACUTE TOXICITY DATA **
    

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 39 mg/kg/33W-I
TOXIC EFFECTS :
Liver - jaundice, cholestatic
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
AJGAAR American Journal of Gastroenterology. (American College of
Gastroenterology, Inc., 428 E. Preston St., Baltimore, MD 21202) V.21-
1954- Volume(issue)/page/year: 82,461,1987

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 2500 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: 6,830,1982

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1050 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: 6,830,1982

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
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: 6,830,1982

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 1860 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: 6,830,1982

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 400 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: 6,830,1982

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
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: 6,830,1982

             ** OTHER MULTIPLE DOSE TOXICITY DATA **

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 378 mg/kg/27W-I
TOXIC EFFECTS :
Liver - other changes
Kidney, Ureter, Bladder - changes in bladder weight
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
TXCYAC Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85,
Limerick, Ireland) V.1- 1973- Volume(issue)/page/year: 7,357,1977

                      ** TUMORIGENIC DATA **

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 5366 mg/kg/7Y-C
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - tumors
REFERENCE :
BJSUAM British Journal of Surgery. (Quadrant Subscription Services Ltd.,
Oakfield House, Perrymount Rd., Haywards Heath, W. Sussex RH16 3DH, UK) V.1-
1913- Volume(issue)/page/year: 66,212,1979

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 420 mg/kg/4Y-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 : Human - woman
DOSE : 30 mg/kg
SEX/DURATION : female 6-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
MACPAJ Mayo Clinic Proceedings. (Room 1035, Plummer Bldg., Mayo Clinic,
Rochester, MN 55905) V.39- 1964- Volume(issue)/page/year: 32,41,1957

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 37800 ug/kg
SEX/DURATION : female 12-31 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 2,267,1958

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 25200 ug/kg
SEX/DURATION : female 7-14 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:
52,279,1958

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 210 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 : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 9 mg/kg
SEX/DURATION : female 15-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
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: 5,331,1963

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 4 mg/kg
SEX/DURATION : male 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper’s gland,
accessory glands
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 1,87,1970

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 14 mg/kg
SEX/DURATION : male 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper’s gland,
accessory glands
Reproductive - Paternal Effects - other effects on male
REFERENCE :
ACENA7 Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E,
DK-2500 Valby, Denmark) V.1- 1948- Volume(issue)/page/year: 22,318,1956

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 112 mg/kg
SEX/DURATION : male 14 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
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: 71,500,1958

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - rat
DOSE : 1900 ug/kg
SEX/DURATION : female 1-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
GTPZAB Gigiena Truda i Professional’nye Zabolevaniya. Labor Hygiene and
Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR)
V.1-36, 1957-1992. For publisher information, see MTPEEI
Volume(issue)/page/year: 22(6),25,1978

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 16800 ug/kg
SEX/DURATION : male 21 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper’s gland,
accessory glands
REFERENCE :
ACENA7 Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E,
DK-2500 Valby, Denmark) V.1- 1948- Volume(issue)/page/year: 49,145,1965

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 40 ug/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:
22,439,1975

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 100 ug/kg
SEX/DURATION : female 17-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - physical
REFERENCE :
ECJPAE Endocrinologia Japonica. (Japan Pub. Trading Co., Ltd., POB 5030,
Tokyo International, Tokyo, Japan) V.1- 1954- Volume(issue)/page/year:
25,1,1978

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 100 ug/kg
SEX/DURATION : multigenerations
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
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:
25,1,1978

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 10 mg/kg
SEX/DURATION : female 8 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
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: 48,159,1976

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE : 35 mg/kg
SEX/DURATION : female 15-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
PTRBAE Philosophical Transactions of the Royal Society of London, Series B:
Biological Sciences. (Royal Soc., 6 Carlton House Terrace, London SW1Y 5AG,
UK) V.178- 1887- Volume(issue)/page/year: 259,179,1970

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 30 mg/kg
SEX/DURATION : female 3 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
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: 5,331,1963

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 1280 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
85GRAA “The Control of Fertility,” Pincus, G., New York, Academic Press,
1965 Volume(issue)/page/year: -,150,1965

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 9 mg/kg
SEX/DURATION : female 1-60 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
1,41,1969

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 4500 mg/kg
SEX/DURATION : male 90 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper’s gland,
accessory glands
REFERENCE :
THGNBO Theriogenology. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1974- Volume(issue)/page/year: 33,1057,1990

TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 4500 mg/kg
SEX/DURATION : male 90 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - other effects on male
Endocrine - changes in luteinizing hormone
Endocrine - androgenic
REFERENCE :
THGNBO Theriogenology. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1974- Volume(issue)/page/year: 33,1057,1990

                          *** REVIEWS ***

TOXICOLOGY REVIEW
PCNAA8 Pediatric Clinics of North America. (W.B. Saunders Co., W.
Washington Sq., Philadelphia, PA 19105) V.1- 1954-
Volume(issue)/page/year: 8,413,1961

TOXICOLOGY REVIEW
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,21,1959

                *** OCCUPATIONAL EXPOSURE LIMITS ***

OEL-RUSSIA:STEL 0.005 mg/m3 JAN 1993

     *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOHS - National Occupational Hazard Survey (1974)
NOHS Hazard Code - 80462
No. of Facilities: 129 (estimated)
No. of Industries: 2
No. of Occupations: 8
No. of Employees: 7715 (estimated)

                      *** STATUS IN U.S. ***

EPA GENETOX PROGRAM 1988, Negative: Sperm morphology-human

EPA TSCA Section 8(b) CHEMICAL INVENTORY

                        *** END OF RECORD ***