*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : XH5600000
CHEMICAL NAME           : Theophylline, compd. with ethylenediamine (2:1)
CAS REGISTRY NUMBER     : 317-34-0
OTHER CAS REGISTRY NOS. : 8013-40-9
                          12767-26-9
LAST UPDATED            : 199701
DATA ITEMS CITED        : 35
MOLECULAR FORMULA       : C7-H8-N4-O2.1/2C2-H8-N2
MOLECULAR WEIGHT        : 210.25
WISWESSER LINE NOTATION : T56 BM DN FNVNVJ F H & 2 &621 &Z2Z &622
COMPOUND DESCRIPTOR     : Drug
                          Mutagen
                          Human
SYNONYMS/TRADE NAMES :
   * Aminocardol
   * Aminodur
   * Aminofilina
   * Aminophylline
   * Ammophyllin
   * Cardophylin
   * Cardophyllin
   * Cardiofilina
   * Cardiomin
   * Carena
   * Cariomin
   * Diaphylline
   * 3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione compd. with  
   1,2-ethanediamine (2:1)
   * Diophyllin
   * Diuxanthine
   * DOBO
   * Dura-Tab S.M. Aminophylline
   * Ethophylline
   * Ethylenediamine, compd. with theophylline (1:2)
   * Etilen-xantisan tabl.
   * Eufilina
   * Euphyllin
   * Euphylline
   * Euufilin
   * Eurphyllin
   * Genophyllin
   * Grifomin
   * Inophylline
   * Lasodex
   * Linampheta
   * Metaphyllin
   * Metaphylline
   * Methophylline
   * Minaphil
   * Miofilin
   * Neophyiline
   * Peterphyllin
   * Phylcardin
   * Phyllindon
   * Phyllocontin
   * 1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, compd. with  
   1,2-ethanediamine (2:1)
   * Rectalad-aminophylline
   * Somophyllin
   * Somophyllin O
   * Stenovasan
   * TAD
   * Tefamin
   * Theodrox
   * Theolamine
   * Theolone
   * Theomin
   * Theophyldine
   * Theophyllamine
   * Theophyllaminium
   * Theophyllin aethylendiamin
   * Theophylline ethylenediamine
   * Theophyllin ethylenediamine
   * Thephyldine
   * TH/100
   * Vasofilina
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 1420 ug/kg
TOXIC EFFECTS :
   Cardiac - other changes
   Lungs, Thorax, or Respiration - other changes
REFERENCE :
   JAMAAP JAMA, Journal of the American Medical Association.  (AMA, 535 N.
   Dearborn St., Chicago, IL 60610)  V.1-    1883-  Volume(issue)/page/year:
   123,1115,1943
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - infant
DOSE/DURATION           : 7595 mg/kg/5D-I
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Gastrointestinal - hypermotility, diarrhea
REFERENCE :
   PEDIAU Pediatrics.  (American Academy of Pediatrics, P.O. Box 1034,
   Evanston, IL 60204) V.1-    1948-  Volume(issue)/page/year: 71,615,1983
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 19 mg/kg/3D
TOXIC EFFECTS :
   Behavioral - withdrawal
   Gastrointestinal - nausea or vomiting
REFERENCE :
   BCPHBM British Journal of Clinical Pharmacology.  (Blackwell Scientific Pub.
   Ltd., POB 88, Oxford, UK)  V.1-    1974-  Volume(issue)/page/year:
   10,101,1980
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 120 mg/kg
TOXIC EFFECTS :
   Endocrine - hyperglycemia
   Nutritional and Gross Metabolic - changes in potassium
   Nutritional and Gross Metabolic - metabolic acidosis
REFERENCE :
   AJEMEN American Journal of Emergency Medicine.  (WB Saunders, Philadelphia,
   PA)  V.1-    1983-  Volume(issue)/page/year: 3,408,1985
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human
DOSE/DURATION           : 139 mg/kg/7D-C
TOXIC EFFECTS :
   Behavioral - muscle contraction or spasticity
   Behavioral - coma
   Cardiac - arrhythmias (including changes in conduction)
REFERENCE :
   CLCHAU Clinical Chemistry (Winston-Salem, NC).  (American Assoc. for
   Clinical Chemistry, 1725 K St., NW, Washington, DC 20006)  V.1-    1955-
   Volume(issue)/page/year: 24,1603,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Rectal
SPECIES OBSERVED        : Human - child
DOSE/DURATION           : 39 mg/kg/8H
TOXIC EFFECTS :
   Behavioral - coma
   Gastrointestinal - nausea or vomiting
   Nutritional and Gross Metabolic - dehydration
REFERENCE :
   JAMAAP JAMA, Journal of the American Medical Association.  (AMA, 535 N.
   Dearborn St., Chicago, IL 60610)  V.1-    1883-  Volume(issue)/page/year:
   161,693,1956
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Rectal
SPECIES OBSERVED        : Human - child
DOSE/DURATION           : 221 mg/kg/3D
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Gastrointestinal - nausea or vomiting
   Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
   JAMAAP JAMA, Journal of the American Medical Association.  (AMA, 535 N.
   Dearborn St., Chicago, IL 60610)  V.1-    1883-  Volume(issue)/page/year:
   161,693,1956
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 243 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   BCFAAI Bollettino Chimico Farmaceutico.  (Societa Editoriale Farmaceutica,
   Via Ausonio 12, 20123 Milan, Italy)  V.33-    1894- Volume(issue)/page/year:
   110,653,1971
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 129 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   EJMCA5 European Journal of Medicinal Chemistry--Chimie Therapeutique.
   (Editions Scientifiques Elsevier, 29 rue Buffon, F-75005, Paris, France)
   V.9-    1974-  Volume(issue)/page/year: 29,295,1994
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 176 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
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: 230,194,1957
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 104 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   EJMCA5 European Journal of Medicinal Chemistry--Chimie Therapeutique.
   (Editions Scientifiques Elsevier, 29 rue Buffon, F-75005, Paris, France)
   V.9-    1974-  Volume(issue)/page/year: 29,295,1994
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 167 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - respiratory stimulation
   Gastrointestinal - changes in structure or function of salivary glands
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 29,1013,1979
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 150 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
REFERENCE :
   JLCMAK Journal of Laboratory and Clinical Medicine.  (C.V. Mosby Co., 11830
   Westline Industrial Dr., St. Louis, MO 63141)  V.1-    1915-
   Volume(issue)/page/year: 31,1337,1946
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 37 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   STRAAA Strahlentherapie.  (Urban & Schwarzenberg, Postfach 202440, D-8000
   Munich 2, Fed. Rep. Ger.) V.1-    1912-  Volume(issue)/page/year:
   127,245,1965
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 186 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 4,649,1954
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 125 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   EJMCA5 European Journal of Medicinal Chemistry--Chimie Therapeutique.
   (Editions Scientifiques Elsevier, 29 rue Buffon, F-75005, Paris, France)
   V.9-    1974-  Volume(issue)/page/year: 29,295,1994
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 215 mg/kg
TOXIC EFFECTS :
   Behavioral - tremor
   Behavioral - convulsions or effect on seizure threshold
REFERENCE :
   CTYAD8 Zhongcaoyao.  Chinese Traditional and Herbal Medicine.  (China
   International Book Trading Corp., POB 2820, Beijing, Peop. Rep. China) V.11-
      1980-  Volume(issue)/page/year: 11,555,1980
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Unreported
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 350 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   RPTOAN Russian Pharmacology and Toxicology (English Translation).
   Translation of FATOAO.  (Euromed Pub., 33, Woodlands Rd., Surbiton, Surrey,
   UK)  V.30-    1967-  Volume(issue)/page/year: 48,67,1985
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 200 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   BTSRAF Biochimica e Terapia Sperimentale.  (Milan, Italy)  V.1-30, 1909-43.
   For publisher information, see NIVAAY.  Volume(issue)/page/year: 29,69,1942
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 150 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   BTSRAF Biochimica e Terapia Sperimentale.  (Milan, Italy)  V.1-30, 1909-43.
   For publisher information, see NIVAAY.  Volume(issue)/page/year: 29,69,1942
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Rectal
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 200 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   BTSRAF Biochimica e Terapia Sperimentale.  (Milan, Italy)  V.1-30, 1909-43.
   For publisher information, see NIVAAY.  Volume(issue)/page/year: 29,69,1942
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 330 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   THMOAM Therapeutische Monatshefte.  (Berlin, Germany)  V.1-33, 1887-1919.
   For publisher information, see KLWOAZ.  Volume(issue)/page/year: 24,613,1910
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 150 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
REFERENCE :
   JLCMAK Journal of Laboratory and Clinical Medicine.  (C.V. Mosby Co., 11830
   Westline Industrial Dr., St. Louis, MO 63141)  V.1-    1915-
   Volume(issue)/page/year: 31,1337,1946
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 184 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - respiratory stimulation
   Gastrointestinal - changes in structure or function of salivary glands
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 29,1013,1979
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 130 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   GWXXBX German Offenlegungsschrift Patent Document.  (U.S. Patent and
   Trademark Office, Foreign Patents, Washington, DC 20231)
   Volume(issue)/page/year: #2445399
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 222 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
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: 230,194,1957
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 143 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - respiratory stimulation
   Gastrointestinal - changes in structure or function of salivary glands
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 29,1013,1979
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 2400 mg/kg/12D-I
TOXIC EFFECTS :
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
   Related to Chronic Data - death
REFERENCE :
   TXAPA9 Toxicology and Applied Pharmacology.  (Academic Press, Inc., 1 E.
   First St., Duluth, MN 55802) V.1-    1959-  Volume(issue)/page/year:
   7,291,1965
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 200 mg/kg/8D-I
TOXIC EFFECTS :
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
   Immunological Including Allergic - increase in humoral immune response
REFERENCE :
   CYLPDN Zhongguo Yaoli Xuebao.  Acta Pharmacologica Sinica.  Chinese Journal
   of Pharmacology.  (China International Book Trading Corp., POB 2820,
   Beijing, Peop. Rep. China)  V.1-    1980-  Volume(issue)/page/year:
   10,457,1989
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 175 mg/kg/7D-I
TOXIC EFFECTS :
   Immunological Including Allergic - decrease in cellular immune response
REFERENCE :
   CYLPDN Zhongguo Yaoli Xuebao.  Acta Pharmacologica Sinica.  Chinese Journal
   of Pharmacology.  (China International Book Trading Corp., POB 2820,
   Beijing, Peop. Rep. China)  V.1-    1980-  Volume(issue)/page/year:
   10,457,1989
 
                            ** MUTATION DATA **
 
TYPE OF TEST            : Cytogenetic analysis
TEST SYSTEM             : Rodent - mouse Mammary gland
DOSE/DURATION           : 500 mg/L/24H (Continuous)
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: 5,141,1980

                    *** OCCUPATIONAL EXPOSURE LIMITS ***
 
   OEL-RUSSIA:STEL 0.5 mg/m3 JAN 1993

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

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOHS - National Occupational Hazard Survey (1974)
     NOHS Hazard Code - 84313
       No. of Facilities: 2405 (estimated)
       No. of Industries: 4
       No. of Occupations: 18
       No. of Employees: 10320 (estimated)
   
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - 84313
       No. of Facilities: 724 (estimated)
       No. of Industries: 5
       No. of Occupations: 16
       No. of Employees: 37320 (estimated)
       No. of Female Employees: 28051 (estimated)

                          *** STATUS IN U.S. ***
 
   EPA TSCA Section 8(b) CHEMICAL INVENTORY

 
                            *** END OF RECORD ***