*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : TU3830000
CHEMICAL NAME           : Pregna-1,4-diene-3,20-dione,
                          6,9-difluoro-11,12-dihydroxy-16,17-((1-methylethylide
                          ne) bis(oxy))-, (6-alpha,11-beta,16-alpha)-
CAS REGISTRY NUMBER     : 67-73-2
LAST UPDATED            : 199710
DATA ITEMS CITED        : 21
MOLECULAR FORMULA       : C24-H30-F2-O6
MOLECULAR WEIGHT        : 452.54
WISWESSER LINE NOTATION : T F5 E5 B666 GO IO RV AHTTTT&J A BF CQ E FVIQ H H  OF
                          -A&BHO -B&ACEF
COMPOUND DESCRIPTOR     : Drug
                          Mutagen
                          Reproductive Effector
SYNONYMS/TRADE NAMES :
   * Dermalar
   * 6-alpha,9-alpha-Difluoro-16-alpha-hydroxyprednisolone 16,17-acetonide
   * Flucinar
   * Fluocinolone acetonide
   * Fluocinolone 16,17-acetonide
   * Fluovitif
   * Jellin
   * Localyn
   * Percutina
   * Radiocin
   * RS-1401 AT
   * Sinalar
   * Synamol
   * Synandone
   * Synalar
   * Synandrone
   * Synsac
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : >4 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: 6,694,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 42 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: 6,694,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 108 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: 6,694,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : >4 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: 6,694,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 103 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: 6,694,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 200 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: 6,694,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : >3170 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: 6,694,1982
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 1750 ug/kg/35D-I
TOXIC EFFECTS :
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
   Related to Chronic Data - death
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 27,2102,1977
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 1 mg/kg
SEX/DURATION            : female 1-20 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
   before birth)
   Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
   e.g., stunted fetus)
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 27,2102,1977
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rabbit
DOSE                    : 1200 ug/kg
SEX/DURATION            : female 8-31 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Newborn - stillbirth
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 27,2102,1977
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rabbit
DOSE                    : 1625 ug/kg
SEX/DURATION            : female 6-18 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - abortion
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 37,43,1987
 
                            ** MUTATION DATA **
 
TYPE OF TEST            : Mutation test systems - not otherwise specified
TEST SYSTEM             : Human Lymphocyte
DOSE/DURATION           : 500 nmol/L
REFERENCE :
   BCPCA6 Biochemical Pharmacology.  (Pergamon Press Inc., Maxwell House,
   Fairview Park, Elmsford, NY 10523)  V.1-    1958-  Volume(issue)/page/year:
   19,1471,1970
 
TYPE OF TEST            : DNA inhibition
TEST SYSTEM             : Rodent - mouse Lymphocyte
DOSE/DURATION           : 500 nmol/L
REFERENCE :
   BCPCA6 Biochemical Pharmacology.  (Pergamon Press Inc., Maxwell House,
   Fairview Park, Elmsford, NY 10523)  V.1-    1958-  Volume(issue)/page/year:
   19,1471,1970
 
TYPE OF TEST            : Mutation test systems - not otherwise specified
ROUTE OF EXPOSURE       : Administration onto the skin
TEST SYSTEM             : Human
DOSE/DURATION           : 2000 ppm
REFERENCE :
   ARDEAC Archives of Dermatology.  (AMA, 535 N. Dearborn St., Chicago, IL
   60610)  V.82-    1960-  Volume(issue)/page/year: 103,39,1971
 
TYPE OF TEST            : DNA inhibition
TEST SYSTEM             : Rodent - rat Embryo
DOSE/DURATION           : 10 gm/L
REFERENCE :
   CRNGDP Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House,
   Southfield Road, Eynsham, Oxford OX8 1JJ, UK)  V.1-    1980-
   Volume(issue)/page/year: 4,653,1983
 
TYPE OF TEST            : DNA inhibition
ROUTE OF EXPOSURE       : Administration onto the skin
TEST SYSTEM             : Rodent - mouse
DOSE/DURATION           : 40 ug/kg
REFERENCE :
   CBINA8 Chemico-Biological Interactions.  (Elsevier Scientific Pub. Ireland
   Ltd., POB 85, Limerick, Ireland)  V.1-    1969-  Volume(issue)/page/year:
   17,331,1977
 
TYPE OF TEST            : Morphological transformation
TEST SYSTEM             : Rodent - hamster Embryo
DOSE/DURATION           : 620 ug/L
REFERENCE :
   AETODY Advances in Modern Environmental Toxicology.  (Senate Press, Inc.,
   P.O. Box 252, Princeton Junction, NJ 08550)  V.1-    1980-
   Volume(issue)/page/year: 1,241,1980

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

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOHS - National Occupational Hazard Survey (1974)
     NOHS Hazard Code - 83287
       No. of Facilities: 100 (estimated)
       No. of Industries: 2
       No. of Occupations: 3
       No. of Employees: 1551 (estimated)
   
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - 83287
       No. of Facilities: 72 (estimated)
       No. of Industries: 1
       No. of Occupations: 5
       No. of Employees: 4106 (estimated)
       No. of Female Employees: 3249 (estimated)

                          *** STATUS IN U.S. ***
 
   EPA GENETOX PROGRAM 1988, Positive: Cell transform.-SA7/SHE
   
   EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998

 
                            *** END OF RECORD ***