*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : KE7625000
CHEMICAL NAME : Ergotaman-3',6',18-trione,
2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpr
opyl)-, (5'-alpha)-
CAS REGISTRY NUMBER : 25614-03-3
LAST UPDATED : 199703
DATA ITEMS CITED : 38
MOLECULAR FORMULA : C32-H40-Br-N5-O5
MOLECULAR WEIGHT : 654.68
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Bromergocryptine
* Bromocriptin
* Bromocriptine
* Bromocryptine
* Bromoergocriptine
* alpha-Bromoergocriptine
* Bromoergocryptine
* 2-Bromoergocryptine
* 2-Bromo-alpha-ergocryptine
* 2-Bromo-alpha-ergokryptin
* 2-Bromo-alpha-ergokryptine
* 2-Bromo-12'-hydroxy-2'-(1-methylethyl)-5'-alpha-(2-methylpropyl)ergotami
n-3',6',18-trione
* Ergocryptine, 2-bromo-
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 6 mg/kg/60D-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Olfaction) - effect, not otherwise
specified
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
306,178,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 72 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
DRUGAY Drugs. International Journal of Current Therapeutics and Applied
Pharmacology Reviews. (ADIS Press International Inc., Suite B-30, Oxford
Ct. Business Center, 582 Middletown Blvd., Langhorne, PA 19047) V.1- 1971-
Volume(issue)/page/year: 17,313,1979
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >800 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
EJMCA5 European Journal of Medicinal Chemistry--Chimie Therapeutique.
(Editions Scientifiques Elsevier, 29 rue Buffon, F-75005, Paris, France)
V.9- 1974- Volume(issue)/page/year: 24,421,1989
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 200 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
BBIADT Biomedica Biochimica Acta. (Akademie-Verlag GmbH, Postfach 1233,
Berlin DDR-1086, Ger. Dem. Rep.) V.42- 1983- Volume(issue)/page/year:
43,1305,1984
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : >1 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #3752814
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 12 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #3752814
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 7 gm/kg/2Y-C
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Reproductive - Tumorigenic effects - uterine tumors
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
2,1605,1977
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 2423 ug/kg
SEX/DURATION : lactating female 3 week(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects
REFERENCE :
CCMDC7 Critical Care Medicine. (Williams & Wilkins, 428 E. Preston Street,
Baltimore, MD 21202) V.1- 1973- Volume(issue)/page/year: 18,1180,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1500 ug/kg
SEX/DURATION : lactating female 9 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
2,743,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1500 ug/kg
SEX/DURATION : lactating female 15 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
REFERENCE :
OBGNAS Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1953- Volume(issue)/page/year:
41,884,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1750 ug/kg
SEX/DURATION : lactating female 21 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
REFERENCE :
BJOGAS British Journal of Obstetrics and Gynaecology. (Blackwell Scientific
Pub. Ltd., POB 88, Oxford, UK) V.82- 1975- Volume(issue)/page/year:
98,270,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 21700 ug/kg
SEX/DURATION : female 28 week(s) pre-mating
female 1-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - respiratory system
REFERENCE :
BCPHBM British Journal of Clinical Pharmacology. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1974- Volume(issue)/page/year:
5,227,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 3500 ug/kg
SEX/DURATION : female 14 day(s) pre-mating
female 1-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
BCPHBM British Journal of Clinical Pharmacology. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1974- Volume(issue)/page/year:
5,227,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 11900 ug/kg
SEX/DURATION : female 77 day(s) pre-mating
female 1-42 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
BCPHBM British Journal of Clinical Pharmacology. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1974- Volume(issue)/page/year:
5,227,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 11200 ug/kg
SEX/DURATION : female 44 day(s) pre-mating
female 1-12 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
BCPHBM British Journal of Clinical Pharmacology. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1974- Volume(issue)/page/year:
5,227,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 2800 ug/kg
SEX/DURATION : female 24-52 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - body wall
REFERENCE :
BCPHBM British Journal of Clinical Pharmacology. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1974- Volume(issue)/page/year:
5,227,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 70 mg/kg
SEX/DURATION : female 13-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - behavioral
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: 33,100C,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 1950 ug/kg
SEX/DURATION : female 5-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #3752814
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 5100 ug/kg
SEX/DURATION : lactating female 3 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #3752814
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 17500 ug/kg
SEX/DURATION : male 35 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
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: 22,164,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 88 mg/kg
SEX/DURATION : female 1-22 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)
Reproductive - Fertility - other measures of fertility
REFERENCE :
ARCGDG Archives of Gynecology. (Springer-Verlag New York, Inc., Service
Center, 44 Hartz Way, Secaucus, NJ 07094) V.226- 1978-
Volume(issue)/page/year: 229,77,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE : 8125 ug/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - extra-embryonic structures
(e.g., placenta, umbilical cord)
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
ARCGDG Archives of Gynecology. (Springer-Verlag New York, Inc., Service
Center, 44 Hartz Way, Secaucus, NJ 07094) V.226- 1978-
Volume(issue)/page/year: 233,31,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 84 mg/kg
SEX/DURATION : lactating female 21 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - weaning or lactation index (e.g., #
alive at weaning per # alive at day 4)
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
EXPEAM Experientia. (Birkhaeuser Verlag, POB 133, CH-4010 Basel,
Switzerland) V.1- 1945- Volume(issue)/page/year: 30,1353,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 200 mg/kg
SEX/DURATION : female 50 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 :
EXPEAM Experientia. (Birkhaeuser Verlag, POB 133, CH-4010 Basel,
Switzerland) V.1- 1945- Volume(issue)/page/year: 30,1353,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 212 mg/kg
SEX/DURATION : female 32 day(s) pre-mating
female 21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
REFERENCE :
EXPEAM Experientia. (Birkhaeuser Verlag, POB 133, CH-4010 Basel,
Switzerland) V.1- 1945- Volume(issue)/page/year: 30,1353,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
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 :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
11,319,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 750 ug/kg
SEX/DURATION : female 43-48 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
THGNBO Theriogenology. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1974- Volume(issue)/page/year: 33,829,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - dog
DOSE : 600 ug/kg
SEX/DURATION : female 42-47 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
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: 81,175,1987
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 8 mg/kg
SEX/DURATION : female 27-30 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
Reproductive - Effects on Embryo or Fetus - other effects to embryo
REFERENCE :
PEREBL Pediatric Research. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1967- Volume(issue)/page/year: 15,183,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - cattle
DOSE : 400 ug/kg
SEX/DURATION : male 50 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
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:
22,781,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - domestic
DOSE : 3 mg/kg
SEX/DURATION : male 84 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 :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
17,192,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - horse, donkey
DOSE : 75200 ug/kg
SEX/DURATION : female 42-49 week(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
Reproductive - Maternal Effects - postpartum
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: 92,179,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - horse, donkey
DOSE : 22400 ug/kg
SEX/DURATION : female 42-44 week(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects
Endocrine - estrogenic
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: 92,179,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - species unspecified
DOSE : 1 mg/kg
SEX/DURATION : female 23 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4
per # born alive)
REFERENCE :
RFDEEH Reproduction, Fertility and Development. (Reproduction, Fertility
and Development, 314 Albert Street, East Melbourne, Victoria 3002 Australia)
V.2- 1990- Volume(issue)/page/year: 2,79,1990
** MUTATION DATA **
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 100 umol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 117,163,1983
TYPE OF TEST : DNA inhibition
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 4 mg/kg
REFERENCE :
CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut
Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year:
36,2223,1976
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X6252
No. of Facilities: 9 (estimated)
No. of Industries: 1
No. of Occupations: 1
No. of Employees: 339 (estimated)
No. of Female Employees: 170 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Negative: Sperm morphology-human
*** END OF RECORD ***