*** 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 ***