*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : TU3850000
CHEMICAL NAME : Pregna-1,4-diene-3,20-dione,
9-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-
CAS REGISTRY NUMBER : 124-94-7
BEILSTEIN REFERENCE NO. : 2341955
REFERENCE : 4-08-00-03629 (Beilstein Handbook Reference)
LAST UPDATED : 199710
DATA ITEMS CITED : 20
MOLECULAR FORMULA : C21-H27-F-O6
MOLECULAR WEIGHT : 394.48
WISWESSER LINE NOTATION : L E5 B666 OV KU MUTJ A1 BF CQ E1 FV1Q FQ GQ
COMPOUND DESCRIPTOR : Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Aristocort
* 9-alpha-Fluoro-16-alpha-hydroxyprednisolone
* 9-alpha-Fluoro-11-beta,16-alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-
dione
* 9-alpha-Fluoro-11-beta,16-alpha,17,21-tetrahydroxy-1,4-pregnadiene-3,20-
dione
* 9-alpha-Fluoro-11-beta,16-alpha,17-alpha,21-tetrahydroxypregna-1,4-diene
-3,20-dione
* 9-Fluoro-11-beta,16-alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
* Fluoxyprednisolone
* Kenacort
* Pregna-1,4-diene-3,20-dione, 9-fluoro-11,16,17,21-tetrahydroxy-,
(11-beta,16-alpha)-
* SK-Triamcinolone
* Rodinolone
* 11-beta,16-alpha,17-alpha,21-Tetrahydroxy-9-alpha-fluoro-1,4-pregnadiene
-3,20-dione
* Triamcinolone
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 1200 ug/kg
TOXIC EFFECTS :
Musculoskeletal - other changes
REFERENCE :
BJRHDF British Journal of Rheumatology. (Bailliere Tindall, 33 The Avenue,
Eastborn BN21 3UN, UK) Volume(issue)/page/year: 34,385,1995
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 99 mg/kg
TOXIC EFFECTS :
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
8,250,1966
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >4 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
YAKUD5 Gekkan Yakuji. Pharmaceuticals Monthly. (Yakugyo Jihosha, Inaoka
Bldg., 2-36 Jinbo-cho, Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1959-
Volume(issue)/page/year: 21,2117,1979
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 105 mg/kg/6W-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - urine volume increased
Blood - other changes
Related to Chronic Data - death
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
1,305,1959
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 12600 ug/kg
SEX/DURATION : female 1-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
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: 96,985,1966
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1 gm/kg
SEX/DURATION : female 4-8 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 :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 22,735,1971
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1 gm/kg
SEX/DURATION : female 9-13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - stillbirth
REFERENCE :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 22,735,1971
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE : 10 mg/kg
SEX/DURATION : female 13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc.,
41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year:
3,313,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE : 20 mg/kg
SEX/DURATION : female 13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc.,
41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year:
3,313,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE : 100 mg/kg
SEX/DURATION : female 8-12 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - live birth index (measured after birth)
Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4
per # born alive)
REFERENCE :
TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc.,
41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year:
7,7,1987
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE : 10 mg/kg
SEX/DURATION : female 11 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - cytological changes (including
somatic cell genetic material)
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
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: 4,227,1971
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Primate - monkey
DOSE : 30 mg/kg
SEX/DURATION : female 63-65 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - blood and lymphatic
systems (including spleen and marrow)
REFERENCE :
DABBBA Dissertation Abstracts International, B: The Sciences and
Engineering. (University Microfilms International, 300 N. Zeeb Rd., Ann
Arbor, MI 48106) V.30- 1969- Volume(issue)/page/year: 38,145,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rabbit
DOSE : 4 mg/kg
SEX/DURATION : female 13-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
APTOD9 Abstracts of Papers, Society of Toxicology. Annual Meetings.
(Academic Press, Inc., 1 E. First St., Duluth, MN 55802)
Volume(issue)/page/year: 19,A90,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - pig
DOSE : 10500 ug/kg
SEX/DURATION : female 15-16 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - behavioral
Reproductive - Effects on Newborn - physical
REFERENCE :
THGNBO Theriogenology. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1974- Volume(issue)/page/year: 30,137,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - hamster
DOSE : 2 mg/kg
SEX/DURATION : female 11 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 :
JEEMAF Journal of Embryology and Experimental Morphology. (Essex, UK)
V.1-98, 1953-86. For Publisher information, see DEVPED
Volume(issue)/page/year: 36,101,1976
** MUTATION DATA **
TYPE OF TEST : Mutation test systems - not otherwise specified
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Human
DOSE/DURATION : 428 ug/kg
REFERENCE :
ARDEAC Archives of Dermatology. (AMA, 535 N. Dearborn St., Chicago, IL
60610) V.82- 1960- Volume(issue)/page/year: 103,39,1971
*** REVIEWS ***
TOXICOLOGY REVIEW
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: 96,985,1966
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOHS - National Occupational Hazard Survey (1974)
NOHS Hazard Code - M2730
No. of Facilities: 174 (estimated)
No. of Industries: 1
No. of Occupations: 1
No. of Employees: 174 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - M2730
No. of Facilities: 98 (estimated)
No. of Industries: 1
No. of Occupations: 3
No. of Employees: 2926 (estimated)
No. of Female Employees: 2097 (estimated)
*** STATUS IN U.S. ***
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998
*** END OF RECORD ***