*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : TU4075000
CHEMICAL NAME : Pregna-4,6-diene-3,20-dione, 17-hydroxy-6-methyl-,
acetate
CAS REGISTRY NUMBER : 595-33-5
LAST UPDATED : 199806
DATA ITEMS CITED : 40
MOLECULAR FORMULA : C24-H32-O4
MOLECULAR WEIGHT : 384.56
WISWESSER LINE NOTATION : L E5 B666 OV KU MUTJ A1 E1 FV1 FOV1 L1
COMPOUND DESCRIPTOR : Tumorigen
Mutagen
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* 17-alpha-Acetoxy-6-dehydro-6-methylprogesterone
* 17-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
* 17-alpha-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
* 17-alpha-Acetoxy-6-methyl-4,6-pregnadiene-3,20-dione
* BDH 1298
* 6-Dehydro-6-methyl-17-alpha-acetoxyprogesterone
* DMAP
* 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
* Megace
* Megeron
* Megestrol acetate
* Megestryl acetate
* 6-Methyl-17-alpha-acetoxypregna-4,6-diene-3,20-dione
* 6-Methyl-6-dehydro-17-alpha-acetoxyprogesterone
* 6-Methyl-delta(sup 6)-dehydro-17-alpha-acetoxyprogesterone
* 6-Methyl-6-dehydro-17-alpha-acetylprogesterone
* 6-Methyl-17-alpha-hydroxy-delta(sup 6)-progesterone acetate
* 6-Methyl-delta(sup 4,6)-pregnadien-17-alpha-ol-3,20-dione acetate
* Niagestin
* NSC-71423
* Ovaban
* SC10363
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 56 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
CSLNX* U.S. Army Armament Research & Development Command, Chemical Systems
Laboratory, NIOSH Exchange Chemicals. (Aberdeen Proving Ground, MD 21010)
Volume(issue)/page/year: NX#00931
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 256 mg/kg/7Y-C
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Skin and Appendages - tumors
Endocrine - diabetes mellitus
REFERENCE :
JTEHD6 Journal of Toxicology and Environmental Health. (Hemisphere Pub.,
1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76-
Volume(issue)/page/year: 3,167,1977
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 182 mg/kg/2Y-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Skin and Appendages - 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:
219,1601,1972
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 210 ug/kg
SEX/DURATION : female 21 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 :
PMESAJ Postgraduate Medical Journal, Supplement. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1949- Volume(issue)/page/year:
43(Suppl),45,1967
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1825 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 :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
2,730,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 2430 ug/kg
SEX/DURATION : female 34 week(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: 6,361,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1820 ug/kg
SEX/DURATION : female 26 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 7,503,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Human - woman
DOSE : 1800 ug/kg
SEX/DURATION : female 30 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 :
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: 105,1135,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Human - woman
DOSE : 1440 ug/kg
SEX/DURATION : female 43 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: 105,1139,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Human - woman
DOSE : 1440 ug/kg
SEX/DURATION : female 40 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
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: 18,411,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Implant
SPECIES OBSERVED : Human - woman
DOSE : 1840 ug/kg
SEX/DURATION : female 43 week(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: 2,313,1970
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1200 mg/kg
SEX/DURATION : male 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information
Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
Volume(issue)/page/year: 3,213,1965
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 2790 ug/kg
SEX/DURATION : female 50 week(s) pre-mating
female 1-22 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
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: 15,711,1970
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 : 15 mg/kg
SEX/DURATION : male 15 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
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 : 15 mg/kg
SEX/DURATION : female 15 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 - rat
DOSE : 140 mg/kg
SEX/DURATION : female 1-7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
Reproductive - Fertility - other measures of fertility
REFERENCE :
ACENA7 Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E,
DK-2500 Valby, Denmark) V.1- 1948- Volume(issue)/page/year: 54,8,1967
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 7 mg/kg
SEX/DURATION : female 14 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 5,57,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 70 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: 5,57,1972
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 - Fertility - other measures of fertility
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 5,57,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - rat
DOSE : 15 mg/kg
SEX/DURATION : female 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
RPHRA6 Recent Progress In Hormone Research. Proceedings of the Laurentian
Hormone Conference. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802)
V.1- 1947- Volume(issue)/page/year: 20,395,1964
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 3 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 : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 16800 ug/kg
SEX/DURATION : female 21 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: 5,331,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 4600 ug/kg
SEX/DURATION : female 23 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
Reproductive - Maternal Effects - other effects
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: 38,237,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Primate - monkey
DOSE : 100 ug/kg
SEX/DURATION : female 5 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
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: 25,99,1971
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - cat
DOSE : 2 mg/kg
SEX/DURATION : female 1 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: 5,331,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 625 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - mating performance (e.g. # sperm positive females
per # females mated; # copulations per # estrus cycles)
REFERENCE :
ACEDAB Acta Endocrinologica, Supplementum (Copenhagen). (Periodica,
Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948-
Volume(issue)/page/year: 73,17,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 150 ug/kg
SEX/DURATION : female 3 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
Reproductive - Fertility - other measures of fertility
REFERENCE :
BJPCBM British Journal of Pharmacology. (Macmillan Press Ltd., Houndmills,
Basingstoke, Hants. RG21 2XS, UK) V.34- 1968- Volume(issue)/page/year:
40,759,1970
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 37500 ng/kg
SEX/DURATION : female 3 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
BJPCBM British Journal of Pharmacology. (Macmillan Press Ltd., Houndmills,
Basingstoke, Hants. RG21 2XS, UK) V.34- 1968- Volume(issue)/page/year:
40,759,1970
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 8 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
INJFA3 International Journal of Fertility. (Allen Press, 1041 New
Hampshire, St., Lawrence, KS 66044) V.1- 1955- Volume(issue)/page/year:
9,25,1964
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 50 ug/kg
SEX/DURATION : female 5 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
ANREAK Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY
10003) V.1- 1906/08- Volume(issue)/page/year: 142,469,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - cattle
DOSE : 128 ug/kg
SEX/DURATION : female 16 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
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: 18,193,1969
** MUTATION DATA **
TYPE OF TEST : DNA adduct
TEST SYSTEM : Human Liver
DOSE/DURATION : 20 umol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 395,179,1997
TYPE OF TEST : DNA adduct
TEST SYSTEM : Rodent - rat Liver
DOSE/DURATION : 30 umol/L
REFERENCE :
CRNGDP Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House,
Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1980-
Volume(issue)/page/year: 16,1483,1995
TYPE OF TEST : DNA adduct
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 100 mg/kg
REFERENCE :
CRNGDP Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House,
Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1980-
Volume(issue)/page/year: 16,1483,1995
TYPE OF TEST : Unscheduled DNA synthesis
ROUTE OF EXPOSURE : Subcutaneous
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 200 mg/kg
REFERENCE :
JOENAK Journal of Endocrinology. (Biochemical Soc. Book Depot, POB 32,
Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1939-
Volume(issue)/page/year: 60,167,1974
TYPE OF TEST : DNA inhibition
ROUTE OF EXPOSURE : Subcutaneous
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 200 mg/kg
REFERENCE :
JOENAK Journal of Endocrinology. (Biochemical Soc. Book Depot, POB 32,
Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1939-
Volume(issue)/page/year: 60,167,1974
*** REVIEWS ***
IARC Cancer Review:Animal Limited Evidence
IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
V.1- 1972- Volume(issue)/page/year: 21,431,1979
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
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X6284
No. of Facilities: 22 (estimated)
No. of Industries: 1
No. of Occupations: 1
No. of Employees: 771 (estimated)
No. of Female Employees: 372 (estimated)
*** END OF RECORD ***