*** 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 ***