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Pregna - 1,4 - diene - 3,20 - dione, 9 - fluoro - 11 - beta,16 - alpha,17,21 - tetrahydroxy - ,cyclic 16,17 - acetal with acetone

RTECS #: TU3920000

CAS #: 76-25-5

UPDATE: February 2009 MW: 434.55 MF: C24H31FO6


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. MUTATION DATA:
  3. REPRODUCTIVE EFFECTS DATA:
  4. ACUTE TOXICITY DATA:
  5. OTHER MULTIPLE DOSE DATA:
  6. REVIEWS:
  7. STANDARDS AND REGULATIONS:
  8. NIOSH DOCUMENTATION AND SURVEILLANCE:
  9. STATUS IN FEDERAL AGENCIES:
  10. REFERENCES:

SYNONYMS:

  1. 9 - alpha - Fluoro - 11 - beta,21 - dihydroxy - 16 - alpha - isopropylidenedioxy - 1,4 - pregnadiene,3,20 - dione
  2. 9 - alpha - Fluoro - 16 - alpha - 17 - alpha - isopropyledenedioxyprednisolone
  3. 9 - alpha - Fluoro - 16 - alpha - 17 - alpha - isopropylidenedioxy - delta - 1 - hydrocortisone
  4. 9 - alpha - Fluoro - 16 - alpha - hydroxyprednisolone 16 - alpha,17 - alpha - acetonide
  5. 9 - alpha - Fluoro - 16 - hydroxyprednisolone acetonide
  6. Acetospan
  7. Aristocort acetonide
  8. Aristoderm
  9. Aristogel
  10. Flutone
  1. Ftorocort
  2. Kenacort - A
  3. Kenalog
  4. Polcortolon
  5. Tramacin
  6. Triamcinolone 16,17 - acetonide
  7. Triamcinolone acetonide
  8. Triamsinolone acetonide
  9. Tricort
  10. Vetalog


SKIN AND EYE IRRITATION DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
N/R
 N/R N/R N/R


MUTATION DATA AND REFERENCES:

SYSTEM TEST ROUTE/
ORGANISM/
TISSUE 		DOSE REFERENCE
DNA inhibition human other cell types 10 nmol/L CNREA8 43,2664,1983
DNA inhibition mouse other cell types 1 nmol/L ARZNAD 36,1782,1986
DNA inhibition mouse leukocyte 10 nmol/L CNREA8 43,2536,1983
unscheduled DNA synthesis human other cell types 1 nmol/L CNREA8 43,2664,1983
other mutation test systems skin
human 		5,000 ppm ARDEAC 103,39,1971
other mutation test systems skin
human 		5,000 ppm 26UYA8 -,335,1971


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
implant
mouse 		lowest published toxic dose: 650 µg/kg (6-18 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) TJADAB 35,28A,1987
implant
mouse 		lowest published toxic dose: 6,500 µg/kg (6-18 day pregnant) Reproductive: Effects on fertility: Pre- implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea) TJADAB 35,28A,1987
intramuscular
hamster 		lowest published toxic dose: 500 µg/kg (9 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Specific developmental abnormalities: Central nervous system

Reproductive: Other developmental abnormalities 		ANREAK 193,633,1979
intramuscular
hamster 		lowest published toxic dose: 100 µg/kg (11 day pregnant) Reproductive: Specific developmental abnormalities: Endocrine system

Reproductive: Effects on newborn: Biochemical and metabolic 		ANREAK 199,135A,1981
intramuscular
monkey 		lowest published toxic dose: 50 mg/kg (23-31 day pregnant) Reproductive: Specific developmental abnormalities: Central nervous system

Reproductive: Specific developmental abnormalities: Eye, ear

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		TJADAB 28,35,1983
intramuscular
monkey 		lowest published toxic dose: 60 mg/kg (41-44 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Specific developmental abnormalities: Musculoskeletal system

Reproductive: Specific developmental abnormalities: Blood and lymphatic systems (including spleen and marrow) 		FEPRA7 34,1661,1975
intramuscular
monkey 		lowest published toxic dose: 60 mg/kg (41-44 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Effects on embryo or fetus: Fetal death 		FEPRA7 34,1661,1975
intramuscular
monkey 		lowest published toxic dose: 50 mg/kg (23-31 day pregnant) Reproductive: Specific developmental abnormalities: Homeostasis TJADAB 28,35,1983
intramuscular
monkey 		lowest published toxic dose: 3 mg/kg (63-65 day pregnant) Reproductive: Specific developmental abnormalities: Respiratory system FEPRA7 42,797,1983
intramuscular
mouse 		lowest published toxic dose: 480 µg/kg (11-14 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) SCIEAS 149,862,1965
intramuscular
mouse 		lowest published toxic dose: 10 mg/kg (11 day pregnant) Reproductive: Other effects to embryo or fetus FEPRA7 29,348,1970
intramuscular
mouse 		lowest published toxic dose: 5 mg/kg (11 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		PNASA6 67,779,1970
intramuscular
mouse 		lowest published toxic dose: 10 mg/kg (11 day pregnant) Reproductive: Effects on embryo or fetus: Cytological changes (including somatic cell genetic material) PNASA6 67,779,1970
intramuscular
mouse 		lowest published toxic dose: 10 mg/kg (11 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Effects on embryo or fetus: Fetal death

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		TJADAB 26(1),13A,1982
intramuscular
rat 		lowest published toxic dose: 375 µg/kg (12-14 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) TJADAB 27,13,1983
intramuscular
rat 		lowest published toxic dose: 500 µg/kg (14 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Other effects to embryo or fetus 		TJADAB 11,57,1975
intramuscular
rat 		lowest published toxic dose: 750 µg/kg (12-14 day pregnant) Reproductive: Specific developmental abnormalities: Body wall TJADAB 27,13,1983
intramuscular
rat 		lowest published toxic dose: 1,500 µg/kg (12-14 day pregnant) Reproductive: Specific developmental abnormalities: Urogenital system TJADAB 27,13,1983
intramuscular
rat 		lowest published toxic dose: 750 µg/kg (12-14 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on fertility: Litter size (e.g., # fetuses per litter; measured before birth)

Reproductive: Effects on embryo or fetus: Fetal death 		TJADAB 27,13,1983
intraperitoneal
mouse 		lowest published toxic dose: 13 mg/kg (12 day pregnant) Reproductive: Other effects to embryo or fetus TJADAB 18,343,1978
subcutaneous
mouse 		lowest published toxic dose: 12,800 µg/kg (11-14 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) SEIJBO 13,245,1973
subcutaneous
mouse 		lowest published toxic dose: 960 µg/kg (11-14 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) SCIEAS 149,862,1965
subcutaneous
mouse 		lowest published toxic dose: 2,500 µg/kg (12 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		TJADAB 27,395,1983
subcutaneous
mouse 		lowest published toxic dose: 10 mg/kg (11 day pregnant) Reproductive: Effects on embryo or fetus: Fetal death

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		SHKKAN 20,844,1978
subcutaneous
mouse 		lowest published toxic dose: 12,800 µg/kg (11 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) SEIJBO 13,245,1973
subcutaneous
rat 		lowest published toxic dose: 450 µg/kg (11-19 day pregnant) Reproductive: Maternal effects: Parturition

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) 		TJADAB 44,507,1991
subcutaneous
rat 		lowest published toxic dose: 900 mg/kg (11-19 day pregnant) Reproductive: Effects on embryo or fetus: Fetal death TJADAB 44,507,1991
subcutaneous
rat 		lowest published toxic dose: 1 mg/kg (14-15 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) CGANE7 35,133,1995
subcutaneous
rat 		lowest published toxic dose: 2 mg/kg (14-15 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) CGANE7 35,133,1995
skin
woman 		lowest published toxic dose: 101 mg/kg (12-29 week pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Specific developmental abnormalities: Gastrointestinal system 		AJOGAH 162,396,1990


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
N/R
 N/R N/R N/R


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
inhalation
rat 		lowest published toxic concentration: 0.2 mg/m3/4 hour Behavioral: Change in motor activity (specific assay)

Liver: Other changes

Liver: Changes in liver weight 		TOVEFN (4),47,2002
inhalation
rat 		lowest published toxic concentration: 0.2 mg/m3/4 hour Kidney, Ureter, and Bladder: Changes in kidney weight

Endocrine: Hyperglycemia

Endocrine: Changes in thymus weight 		TOVEFN (4),47,2002
inhalation
rat 		lowest published toxic concentration: 0.2 mg/m3/4 hour Blood: Changes in serum composition (e.g. TP, bilirubin, cholesterol)

Blood: Changes in other cell count (unspecified)

Nutritional and Gross Metabolic: Body temperature decrease 		TOVEFN (4),47,2002
inhalation
rat 		lowest published toxic concentration: 0.9 mg/m3/4 hour Endocrine: Other changes

Blood: Luekopenia 		TOVEFN (4),47,2002
intramuscular
man 		lowest published toxic dose: 571 µg/kg Vascular: Shock

Skin: After systemic exposure: Dermatitis, other

Immunological Including Allergic: Anaphylaxis (multiple organ involvement) 		APHRER 28,1310,1994
intraperitoneal
mouse 		lethal dose (50 percent kill): 105 mg/kg N/R NIIRDN 6,516,1982
intraperitoneal
mouse 		lowest published toxic dose: 1 mg/kg Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Hepatic microsomal mixed oxidase (dealkylation, hydroxylation, etc.) FATOAO 53,54,1990
ocular
rabbit 		lowest published toxic dose: 0.95 mg/kg Eye: Corneal damage IJTOFN 24,419,2005
oral
mouse 		lethal dose (50 percent kill): 5 gm/kg N/R YAKUD5 21,2117,1979
oral
mouse 		lethal dose (50 percent kill): 2,168 mg/kg Behavioral: Somnolence (general depressed activity)

Lung, Thorax, or Respiration: Respiratory stimulation

Blood: Hemorrhage 		TOVEFN (4),47,2002
oral
rat 		lethal dose (50 percent kill): 1,451 mg/kg Behavioral: Somnolence (general depressed activity)

Lung, Thorax, or Respiration: Respiratory stimulation

Blood: Hemorrhage 		TOVEFN (4),47,2002
parenteral
woman 		lowest published toxic dose: 4 mg/kg Behavioral: Muscle weakness

Vascular: BP elevation not characterized in autonomic section 		NLJMAV 56,12,2000
subcutaneous
mouse 		lethal dose (50 percent kill): 132 mg/kg N/R NIIRDN 6,516,1982
subcutaneous
rat 		lethal dose (50 percent kill): 13,100 µg/kg N/R DRFUD4 6,44,1981


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
inhalation
human 		lowest published toxic concentration: 18.8 mg/kg/3 year- intermittent Musculoskeletal: Osteoporosis NEJMAG 343,1902,2000
inhalation
human 		lowest published toxic concentration: 4,680 µg/kg/39 week- intermittent Lung, Thorax, or Respiration: Other changes NEJMAG 343,1902,2000
inhalation
monkey 		lowest published toxic dose: 7.252 µg/kg/14 day- intermittent Endocrine: Changes in thymus weight

Lung, Thorax, or Respiration: Other changes 		TOXID9 -,43,2008
inhalation
monkey 		lowest published toxic dose: 28,742 µg/kg/14 day- intermittent Endocrine: Changes in adrenal weight

Lung, Thorax, or Respiration: Changes in lung weight

Related to Chronic Data: Changes in testicular weight 		TOXID9 -,43,2008
parenteral
woman 		lowest published toxic dose: 2 mg/kg Behavioral: Muscle weakness

Vascular: BP elevation not characterized in autonomic section

Blood: Hemorrhage 		NLJMAV 56,12,2000
skin
human 		lowest published toxic dose: 1.7 µg/kg/8 day- intermittent Skin: After systemic exposure: Dermatitis, other BJDEAZ 144,507,2001


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
TOXICOLOGY REVIEW
TJADAB 11,47,1975
TOXICOLOGY REVIEW
DIMON* 25,557,2005
TOXICOLOGY REVIEW
DIMON* 25,557,2005
TOXICOLOGY REVIEW
MUREAV 584,1,2005


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
Occupational Exposure Limit - RUSSIA short term exposure limit 0.001 mg/m3, Skin, JUN2003


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 82031;
Number of Industries 6;
Total Number of Facilities 1,877;
Number of Occupations 7;
Total Number of Employees Exposed 16,168
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 82031;
Number of Industries 2;
Total Number of Facilities 526;
Number of Occupations 10;
Total Number of Employees Exposed 20,690;
Total Number of Female Employees Exposed 11,196


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001


REFERENCES:

CODEN
REFERENCE
26UYA8 "Psoriasis, Proceedings of the International Symposium, Stanford, CA, 1971," Farber, E.M., and A.J. Cox, eds., Stanford, CA, Stanford Univ. Press, 1971
AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920-
ANREAK Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08-
APHRER Annals of Pharmacotherpy. (Harvey Whitney Books Co., POB 42696, Cincinnati, OH 45242) V. 26- 1992-
ARDEAC Archives of Dermatology. (AMA, 535 N. Dearborn St., Chicago, IL 60610) V.82- 1960-
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
BJDEAZ British Journal of Dermatology. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.63- 1951-
CGANE7 Congenital Anomalies. (Nippon Senten Ijo Gakkai, 377-2 Ono-higashi, Osakasayama, Osaka-Fu 589 Japan) V.27- 1987-
CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941-
DIMON* Disease-a Month (Chicago : Year Book Publishers) V. 24- 1978-
DRFUD4 Drugs of the Future. (J.R. Prous, S.A., Apartado de Correos 540, 08080 Barcelona, Spain) V.1- 1975/76-
FATOAO Farmakologiya i Toksikologiya (Moscow). For English translation, see PHTXA6 and RPTOAN. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.2- 1939-
FEPRA7 Federation Proceedings, Federation of American Societies for Experimental Biology. (Bethesda, MD) V.1-46, 1942-87.
IJTOFN International Journal of Toxicology. (Taylor & Francis, 47 Runway Rd., Suite g, Levittown, PA 19057) V.16- 1997-
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10 Shattuck St., Boston, MA 02115) V.198- 1928-
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan)
NLJMAV Netherlands Journal of Medicine. (Elsevier Science, POB 211, 1000 AE Amsterdam. Netherlands) V.16- 1973-
PNASA6 Proceedings of the National Academy of Sciences of the United States of America. (National Academy of Sciences, Printing & Pub. Office, 2101 Constitution Ave., Washington, DC 20418) V.1- 1915-
SCIEAS Science. (American Assoc. for the Advancement of Science, 1333 H St., NW, Washington, DC 20005) V.1- 1895-
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.
SHKKAN Shika Kiso Igakkai Zasshi. Journal of the Japanese Association for Basic Dentistry. (Shika Kiso Igakkai, Hanayama Bldg., 1-44-2 Komagome, Toshima-ku, Tokyo 170, Japan) V.1- 1959-
TJADAB Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
TOVEFN Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway, Akron, OH 44311) V.1- 1981-
YAKUD5 Gekkan Yakuji. Pharmaceuticals Monthly. (Yakugyo Jihosha, Inaoka Bldg., 2-36 Jinbo-cho, Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1959-

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