*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : TU4056000
CHEMICAL NAME : Pregna-1,4-diene-3,20-dione,
9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-,
21-(dihydrogen phosphate) disodium salt
CAS REGISTRY NUMBER : 2392-39-4
LAST UPDATED : 199806
DATA ITEMS CITED : 27
MOLECULAR FORMULA : C22-H28-F-O8-P.2Na
MOLECULAR WEIGHT : 516.45
WISWESSER LINE NOTATION : L E5 B666 OV AHTTT&J A1 BF CQ E1 FV1OPWO FQ G1 &-NA-
2
COMPOUND DESCRIPTOR : Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* Decadron phosphate
* Dexacort
* Dexadreson
* Dexagro
* Dexamethasone disodium phosphate
* Dexamethasone sodium phosphate
* Disodium dexamethasone phosphate
* Megacort
* Sodium dexamethasone phosphate
* Soldesam
* Solu-Decadron
* Spersadox
* Turbinaire
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - infant
DOSE/DURATION : 1500 ug/kg/3D-I
TOXIC EFFECTS :
Brain and Coverings - recordings from specific areas of CNS
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,632,1987
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 320 mg/kg
TOXIC EFFECTS :
Gastrointestinal - other changes
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,1035,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - child
DOSE/DURATION : 1 mg/kg
TOXIC EFFECTS :
Gastrointestinal - peritonitis
REFERENCE :
AJEMEN American Journal of Emergency Medicine. (WB Saunders, Philadelphia,
PA) V.1- 1983- Volume(issue)/page/year: 10,268,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - man
DOSE/DURATION : 357 ug/kg
TOXIC EFFECTS :
Gastrointestinal - peritonitis
REFERENCE :
AJEMEN American Journal of Emergency Medicine. (WB Saunders, Philadelphia,
PA) V.1- 1983- Volume(issue)/page/year: 10,268,1992
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 1800 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ATSUDG Archives of Toxicology, Supplement. (Springer-Verlag New York, Inc.,
Service Center, 44 Hartz Way, Secaucus, NJ 07094) No.1- 1978-
Volume(issue)/page/year: 7,90,1984
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 550 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ATSUDG Archives of Toxicology, Supplement. (Springer-Verlag New York, Inc.,
Service Center, 44 Hartz Way, Secaucus, NJ 07094) No.1- 1978-
Volume(issue)/page/year: 7,90,1984
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 932 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: -,785,1995
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 7500 ug/kg
SEX/DURATION : female 6-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica,
Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year:
119,391,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1 mg/kg
SEX/DURATION : female 6-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica,
Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year:
119,391,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 400 ug/kg
SEX/DURATION : female 19-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
PEDIAU Pediatrics. (American Academy of Pediatrics, P.O. Box 1034,
Evanston, IL 60204) V.1- 1948- Volume(issue)/page/year: 65,287,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 10 mg/kg
SEX/DURATION : female 6-15 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 - fetal death
REFERENCE :
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica,
Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year:
119,391,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 2 mg/kg
SEX/DURATION : female 6-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica,
Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year:
119,391,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 12800 ug/kg
SEX/DURATION : female 11-14 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o
Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho,
Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher
information, see CGANE7. Volume(issue)/page/year: 13,245,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 130 ug/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica,
Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year:
119,391,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 650 ug/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica,
Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year:
119,391,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rabbit
DOSE : 9 mg/kg
SEX/DURATION : female 21-26 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
Reproductive - Effects on Embryo or Fetus - fetal death
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: 64,363,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rabbit
DOSE : 300 ug/kg
SEX/DURATION : female 25-27 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - gastrointestinal
system
REFERENCE :
JSGRA2 Journal of Surgical Research. (Academic Press, Inc., 1 E. First St.,
Duluth, MN 55802) V.1- 1961- Volume(issue)/page/year: 57,274,1994
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 8 mg/kg
SEX/DURATION : female 11-14 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - body wall
REFERENCE :
ANIFAC Annales de Chirurgie Infantile. (Paris, France) V.1- 1960(?)-
Volume(issue)/page/year: 3,73,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 8 mg/kg
SEX/DURATION : female 11-14 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 - fetal death
REFERENCE :
ANIFAC Annales de Chirurgie Infantile. (Paris, France) V.1- 1960(?)-
Volume(issue)/page/year: 3,73,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 4 mg/kg
SEX/DURATION : female 11 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
Reproductive - Fertility - abortion
REFERENCE :
ANIFAC Annales de Chirurgie Infantile. (Paris, France) V.1- 1960(?)-
Volume(issue)/page/year: 3,73,1962
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - domestic
DOSE : 145 ug/kg
SEX/DURATION : female 20 week(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
REFERENCE :
AAAHAN Australian Journal of Experimental Agriculture and Animal Husbandry.
(Commonwealth Scientific and Industrial Research Organization, 314 Albert
St., E. Melbourne, Vic. 3002, Australia) V.1- 1961-
Volume(issue)/page/year: 16,462,1976
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - horse, donkey
DOSE : 2739 ug/kg
SEX/DURATION : female 21 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects
REFERENCE :
JRFSAR Journal of Reproduction and Fertility, Supplement. (Biochemical Soc.
Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) No.1-
1966- Volume(issue)/page/year: 32,247,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - horse, donkey
DOSE : 1304 ug/kg
SEX/DURATION : female 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
JRFSAR Journal of Reproduction and Fertility, Supplement. (Biochemical Soc.
Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) No.1-
1966- Volume(issue)/page/year: 32,247,1982
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOHS - National Occupational Hazard Survey (1974)
NOHS Hazard Code - 82148
No. of Facilities: 67 (estimated)
No. of Industries: 2
No. of Occupations: 1
No. of Employees: 680 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - 82148
No. of Facilities: 363 (estimated)
No. of Industries: 2
No. of Occupations: 7
No. of Employees: 16943 (estimated)
No. of Female Employees: 14180 (estimated)
*** STATUS IN U.S. ***
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998
*** END OF RECORD ***