*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : TU4154060
CHEMICAL NAME           : Pregna-1,4-diene-3,20-dione,
                          11-beta,17,21-trihydroxy-6-alpha-methyl-, 21-
                          (hydrogen succinate), monosodium salt
CAS REGISTRY NUMBER     : 2375-03-3
LAST UPDATED            : 199612
DATA ITEMS CITED        : 26
MOLECULAR FORMULA       : C26-H33-O8.Na
MOLECULAR WEIGHT        : 496.58
WISWESSER LINE NOTATION : L E5 B666 OV AHTTT&J A1 CQ FV1OV2VO FQ L1 &-NA-
COMPOUND DESCRIPTOR     : Drug
                          Reproductive Effector
                          Human
                          Hormone
SYNONYMS/TRADE NAMES :
   * Methylprednisolone sodium succinate
   * 6-alpha-Methylprednisolone sodium succinate
   * MPS
   * Solu-Medrol
   * Solu-Medrone
   * 11-beta,17,21-Trihydroxy-6-alpha-methyl-1,4-pregnadiene-3,20-dione  
   21-(sodium succinate)
   * U 9088
   * Urbason solubile
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 43 mg/kg/3D-I
TOXIC EFFECTS :
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   AIMEAS Annals of Internal Medicine.  (American College of Physicians, 4200
   Pine St., Philadelphia, PA 19104)  V.1-    1927-  Volume(issue)/page/year:
   104,58,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 60 ug/kg/3D-I
TOXIC EFFECTS :
   Cardiac - pulse rate
REFERENCE :
   SJRHAT Scandinavian Journal of Rheumatology.  (Almqvist & Wiksell, POB
   45150, S-10430 Stockholm, Sweden)  V.1-    1972-  Volume(issue)/page/year:
   15,302,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 571 ug/kg/1M-C
TOXIC EFFECTS :
   Cardiac - pulse rate increase, without fall in BP
   Lungs, Thorax, or Respiration - acute pulmonary edema
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   AJEMEN American Journal of Emergency Medicine.  (WB Saunders, Philadelphia,
   PA)  V.1-    1983-  Volume(issue)/page/year: 5,42,1987
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : >5 gm/kg
TOXIC EFFECTS :
   Lungs, Thorax, or Respiration - respiratory stimulation
   Skin and Appendages - hair
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 640 mg/kg
TOXIC EFFECTS :
   Vascular - regional or general arteriolar or venous dilation
   Lungs, Thorax, or Respiration - chronic pulmonary edema
   Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 750 mg/kg
TOXIC EFFECTS :
   Behavioral - stiffness
   Vascular - regional or general arteriolar or venous dilation
   Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 640 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - lacrimation
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : >5 gm/kg
TOXIC EFFECTS :
   Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 880 mg/kg
TOXIC EFFECTS :
   Behavioral - changes in motor activity (specific assay)
   Vascular - regional or general arteriolar or venous dilation
   Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 860 mg/kg
TOXIC EFFECTS :
   Vascular - regional or general arteriolar or venous dilation
   Lungs, Thorax, or Respiration - chronic pulmonary edema
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 750 mg/kg
TOXIC EFFECTS :
   Behavioral - changes in motor activity (specific assay)
   Vascular - regional or general arteriolar or venous dilation
   Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,633,1974
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 300 mg/kg/30D-C
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes in urine composition
   Endocrine - changes in spleen weight
   Blood - changes in erythrocyte (RBC) count
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,637,1974
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 455 mg/kg/13W-C
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes in urine composition
   Endocrine - changes in spleen weight
   Blood - changes in leukocyte (WBC) count
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,649,1974
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 182 mg/kg/26W-C
TOXIC EFFECTS :
   Endocrine - changes in spleen weight
   Blood - changes in leukocyte (WBC) count
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 8,649,1974
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 280 mg/kg/14D-I
TOXIC EFFECTS :
   Endocrine - changes in adrenal weight
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
   JTSCDR Journal of Toxicological Sciences.  (Japanese Soc. of Toxicological
   Sciences, 4th Floor, Gakkai Center Bldg., 4-16, Yayoi 2-chome, Bunkyo-ku,
   Tokyo 113, Japan)  V.1-    1976-  Volume(issue)/page/year: 5,303,1980
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 400 mg/kg/5D-I
TOXIC EFFECTS :
   Immunological Including Allergic - decrease in cellular immune response
REFERENCE :
   TOLED5 Toxicology Letters.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1977-  Volume(issue)/page/year: 13,129,1982
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 320 mg/kg/10D-I
TOXIC EFFECTS :
   Immunological Including Allergic - decrease in cellular immune response
   Immunological Including Allergic - decrease in humoral immune response
REFERENCE :
   TOLED5 Toxicology Letters.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1977-  Volume(issue)/page/year: 13,129,1982
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 240 mg/kg
SEX/DURATION            : female 15-22 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
   e.g., stunted fetus)
   Reproductive - Specific Developmental Abnormalities - musculoskeletal system
   Reproductive - Effects on Newborn - stillbirth
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 16,203,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 80 mg/kg
SEX/DURATION            : female 15-22 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 16,203,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 690 mg/kg
SEX/DURATION            : female 61 day(s) pre-mating
                          female 1-8 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - other measures of fertility
   Reproductive - Effects on Embryo or Fetus - fetal death
   Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 16,193,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 2070 mg/kg
SEX/DURATION            : female 61 day(s) pre-mating
                          female 1-8 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - extra-embryonic structures
   (e.g., placenta, umbilical cord)
   Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
   e.g., stunted fetus)
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 16,193,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 100 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)
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: 33,68C,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 400 mg/kg
SEX/DURATION            : female 6-15 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Specific Developmental Abnormalities - musculoskeletal system
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: 33,68C,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE                    : 300 mg/kg
SEX/DURATION            : female 7-12 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
   e.g., stunted fetus)
REFERENCE :
   KSRNAM Kiso to Rinsho.  Clinical Report.  (Yubunsha Co., Ltd., 1-5, Kanda
   Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan)  V.1-    1960-
   Volume(issue)/page/year: 6,105,1972
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - mouse
DOSE                    : 330 mg/kg
SEX/DURATION            : female 10 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
   resorbed implants per total number of implants)
   Reproductive - Specific Developmental Abnormalities - Central Nervous System
REFERENCE :
   TXAPA9 Toxicology and Applied Pharmacology.  (Academic Press, Inc., 1 E.
   First St., Duluth, MN 55802) V.1-    1959-  Volume(issue)/page/year:
   56,23,1980

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

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - X3735
       No. of Facilities: 175 (estimated)
       No. of Industries: 1
       No. of Occupations: 5
       No. of Employees: 12723 (estimated)
       No. of Female Employees: 10390 (estimated)

 
                            *** END OF RECORD ***