*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : KB2625000
CHEMICAL NAME           : Ephedrine sulfate (2:1) (salt), (-)-
CAS REGISTRY NUMBER     : 134-72-5
LAST UPDATED            : 199710
DATA ITEMS CITED        : 25
MOLECULAR FORMULA       : C20-H30-N2-O2.H2-O4-S
MOLECULAR WEIGHT        : 428.60
WISWESSER LINE NOTATION : QYR&Y1&M1 2 WSQQ -L
COMPOUND DESCRIPTOR     : Tumorigen
                          Drug
                          Mutagen
                          Human
SYNONYMS/TRADE NAMES :
   * l-Ephedrine sulfate
   * Isofedrol
   * 1-alpha-(1-(Methylamino)ethyl)benzyl alcohol sulfate
   * NCI-C55652
   * 1-Phenyl-2-methylamine-propanol-1-sulfate
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human
DOSE/DURATION           : 1 mg/kg
TOXIC EFFECTS :
   Cardiac - pulse rate increase, without fall in BP
   Vascular - BP elevation not characterized in autonomic section
REFERENCE :
   AEPPAE Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und
   Pharmakologie.  (Berlin, Ger.) V.110-253, 1925-66.  For publisher
   information, see NSAPCC.  Volume(issue)/page/year: 120,189,1927
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 404 mg/kg
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
   (usually neuromuscular blockage)
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 94,150,1948
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 318 mg/kg
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
   (usually neuromuscular blockage)
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 94,150,1948
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 102 mg/kg
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
   (usually neuromuscular blockage)
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 94,150,1948
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 812 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Olfaction) - effect, not otherwise
   specified
   Behavioral - somnolence (general depressed activity)
   Behavioral - ataxia
REFERENCE :
   NTPTR* National Toxicology Program Technical Report Series.  (Research
   Triangle Park, NC 27709) No.206-  Volume(issue)/page/year: NTP-TR-307,1986
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 270 mg/kg
TOXIC EFFECTS :
   Behavioral - Straub tail
   Gastrointestinal - changes in structure or function of salivary glands
   Skin and Appendages - hair
REFERENCE :
   TXAPA9 Toxicology and Applied Pharmacology.  (Academic Press, Inc., 1 E.
   First St., Duluth, MN 55802) V.1-    1959-  Volume(issue)/page/year:
   15,304,1969
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 70 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - mydriasis (pupillary dilation)
   Behavioral - muscle weakness
   Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 27,61,1926
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - cat
DOSE/DURATION           : 75 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - mydriasis (pupillary dilation)
   Lungs, Thorax, or Respiration - respiratory stimulation
   Gastrointestinal - nausea or vomiting
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 27,61,1926
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 825 mg/kg
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
   (usually neuromuscular blockage)
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 94,150,1948
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 310 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - mydriasis (pupillary dilation)
   Behavioral - tremor
   Behavioral - convulsions or effect on seizure threshold
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 27,61,1926
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 383 mg/kg
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
   (usually neuromuscular blockage)
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 94,150,1948
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 73 mg/kg
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
   (usually neuromuscular blockage)
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 94,150,1948
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 340 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - mydriasis (pupillary dilation)
   Behavioral - tremor
   Behavioral - convulsions or effect on seizure threshold
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 27,61,1926
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 425 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - mydriasis (pupillary dilation)
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 27,61,1926
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Parenteral
SPECIES OBSERVED        : Amphibian - frog
DOSE/DURATION           : 530 mg/kg
TOXIC EFFECTS :
   Behavioral - muscle weakness
   Behavioral - ataxia
REFERENCE :
   JPETAB Journal of Pharmacology and Experimental Therapeutics.  (Williams &
   Wilkins Co., 428 E. Preston St., Baltimore, MD 21202)  V.1-    1909/10-
   Volume(issue)/page/year: 27,61,1926
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 18200 mg/kg/13W-C
TOXIC EFFECTS :
   Cardiac - changes in heart weight
   Endocrine - changes in adrenal weight
REFERENCE :
   NTPTR* National Toxicology Program Technical Report Series.  (Research
   Triangle Park, NC 27709) No.206-  Volume(issue)/page/year: NTP-TR-307,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 8120 mg/kg/14D-C
TOXIC EFFECTS :
   Blood - other changes
REFERENCE :
   NTPTR* National Toxicology Program Technical Report Series.  (Research
   Triangle Park, NC 27709) No.206-  Volume(issue)/page/year: NTP-TR-307,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 91 gm/kg/13W-C
TOXIC EFFECTS :
   Blood - other changes
REFERENCE :
   NTPTR* National Toxicology Program Technical Report Series.  (Research
   Triangle Park, NC 27709) No.206-  Volume(issue)/page/year: NTP-TR-307,1986
 
                            ** MUTATION DATA **
 
TYPE OF TEST            : DNA damage
TEST SYSTEM             : Rodent - rat Liver
DOSE/DURATION           : 3 mmol/L
REFERENCE :
   MUREAV Mutation Research.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1964-  Volume(issue)/page/year: 368,59,1996

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

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOHS - National Occupational Hazard Survey (1974)
     NOHS Hazard Code - 84417
       No. of Facilities: 2470 (estimated)
       No. of Industries: 4
       No. of Occupations: 9
       No. of Employees: 9457 (estimated)
   
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - 84417
       No. of Facilities: 233 (estimated)
       No. of Industries: 1
       No. of Occupations: 5
       No. of Employees: 5373 (estimated)
       No. of Female Employees: 3199 (estimated)

                          *** STATUS IN U.S. ***
 
   EPA TSCA Section 8(b) CHEMICAL INVENTORY
   
   EPA TSCA Section 8(d) unpublished health/safety studies
   
   EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998
   
   NTP Carcinogenesis Studies (feed);no evidence:mouse,rat
   NTPTR* National Toxicology Program Technical Report Series.  (Research
   Triangle Park, NC 27709) No.206-  Volume(issue)/page/year: NTP-TR-307,86

 
                            *** END OF RECORD ***