The Registry of Toxic Effects of Chemical Substances

Theophylline

RTECS #: XH3850000

CAS #: 58-55-9

UPDATE: May 2005 MW: 180.19 MF: C7H8N4O2


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. NIOSH DOCUMENTATION AND SURVEILLANCE:
  8. STATUS IN FEDERAL AGENCIES:
  9. REFERENCES:

SYNONYMS:

  1. Acet - theocin
  2. Armophylline
  3. Asmax
  4. Austyn
  5. 3,7 - Dihydro - 1,3 - dimethyl - 1H - purine - 2,6 - dione
  6. 1,3 - Dimethylxanthine
  7. Nuelin
  8. NSC 2066
  9. Optiphyllin
  10. Teofilina (Polish)
  11. Teofyllamin
  12. Theophylline, anhydrous
  13. Theal tablets
  14. Theocin
  15. Theograd
  16. Theolair
  17. Theolix
  18. Theophyl - 225
  19. Theophyllin
  1. Duraphy
  2. Elixicon
  3. Elixophyllin
  4. Elixophylline
  5. Euphylong
  6. Lanophyllin
  7. Liquophylline
  8. Parkophyllin
  9. Pseudotheophylline
  10. 1H - Purine - 2,6 - dione, 3,7 - dihydro - 1,3 - dimethyl - (9CI)
  11. Quibron T/SR
  12. Slo - Phyllin
  13. Solosin
  14. Spophyllin retard
  15. Theo - Dur
  16. Theofol
  17. Uniphyllin
  18. Xanthine, 1,3 - dimethyl -


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
cytogenetic analysis hamster lung 450 mg/L GMCRDC 27,95,1981
cytogenetic analysis human lymphocyte 10 mg/L MUREAV 224,409,1989
cytogenetic analysis mouse mammary gland 3,200 µmol/L/24 hour- continuous JTSCDR 5,141,1980
DNA inhibition hamster lung 6 mmol/L MUREAV 26,73,1974
DNA inhibition human fibroblast 7 mg/L NEOLA4 33,699,1986
DNA inhibition human other cell types 4 mmol/L BIOJAU 35,665,1981
DNA inhibition mouse lymphocyte 6 mmol/L MUREAV 26,73,1974
DNA inhibition mouse fibroblast 6 mmol/L MUREAV 26,73,1974
unscheduled DNA synthesis human other cell types 1 mmol/L BIOJAU 35,665,1981
mutation in microorganisms Bacillus subtilis 7,500 mg/L (-enzymatic activation step) MUREAV 117,55,1983
mutation in microorganisms Escherichia coli 150 mg/L (-enzymatic activation step) CSHSAZ 16,337,1952
mutation in microorganisms Euglena gracilis 600 mg/L (-enzymatic activation step) MUREAV 32,169,1975
mutation in microorganisms other microorganisms 6,000 ppm (-enzymatic activation step) NATUAS 162,573,1948
mutation in microorganisms Salmonella typhimurium 10 µg/plate (+enzymatic activation step) MUREAV 444,17,1999
mutation in mammalian somatic cells hamster lung 7 mg/L NEOLA4 33,699,1986
other mutation test systems human lymphocyte 100 µmol/L MUREAV 15,197,1972
other mutation test systems mouse other cell types 100 µmol/L JIDEAE 66,313,1976
other mutation test systems rat other cell types 1 mmol/L INOPAO 13,210,1974
sister chromatid exchange hamster lung 360 mg/L SNSHBT (20),574,1980
sister chromatid exchange hamster ovary 2 mmol/L MUREAV 126,63,1984
sister chromatid exchange oral
hamster 		300 mg/kg EXPEAM 38,600,1982
sister chromatid exchange human embryo 360 mg/L SNSHBT (20),574,1980
sister chromatid exchange human lymphocyte 10 mg/L MUREAV 224,409,1989
sister chromatid exchange intraperitoneal
mouse 		12,500 µg/kg MUREAV 444,17,1999


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intraperitoneal
mouse 		lowest published toxic dose: 175 mg/kg (13 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Specific developmental abnormalities: Musculoskeletal system

Reproductive: Specific developmental abnormalities: Body wall 		OFAJAE 46,167,1969
intraperitoneal
mouse 		lowest published toxic dose: 200 mg/kg (13 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Other developmental abnormalities 		OFAJAE 46,167,1969
intraperitoneal
mouse 		lowest published toxic dose: 225 mg/kg (13 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) OFAJAE 46,167,1969
intravenous
rabbit 		lowest published toxic dose: 18,750 µg/kg (24-26 day pregnant) Reproductive: Effects on newborn: Other neonatal measures or effects PEREBL 12,38,1978
intravenous
rabbit 		lowest published toxic dose: 780 mg/kg (12-18 day pregnant) Reproductive: Other effects on female

Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) 		MFEPDX 22,101,2000
oral
mouse 		lowest published toxic dose: 3 gm/kg (6-15 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

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

Reproductive: Effects on embryo or fetus: Fetal death 		NTIS** PB86-103223
oral
mouse 		lowest published toxic dose: 4,375 mg/kg (7 day male/7 day prior to copulation-3 week pregnant) Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) FAATDF 10,525,1988
oral
mouse 		lowest published toxic dose: 3,720 mg/kg (6-15 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) 		FAATDF 14,167,1990
oral
mouse 		lowest published toxic dose: 17.5 gm/kg (7 day male/7 day prior to copulation/21 day pregnant) Reproductive: Effects on fertility: Other measures of fertility

Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) 		NTIS** #PB85204659/AS
oral
mouse 		lowest published toxic dose: 19 gm/kg (7 day male/7 day prior to copulation/24 day pregnant) Reproductive: Maternal effects: Parturition NTIS** #PB85204659/AS
oral
mouse 		lowest published toxic dose: 4.4 gm/kg (7 day male/7 day prior to copulation/21 day pregnant) Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) NTIS** #PB85204659/AS
oral
mouse 		lowest published toxic dose: 73,500 mg/kg (21 week prior to copulation) Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth)

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) 		NTIS** #PB85204659/AS
oral
rat 		lowest published toxic dose: 10,050 mg/kg (67 day male) Reproductive: Paternal effects: Testes, epididymis, sperm duct FAATDF 10,525,1988
oral
rat 		lowest published toxic dose: 1,500 mg/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) TJADAB 33,70C,1986
oral
rat 		lowest published toxic dose: 75,335 mg/kg (95 day male) Reproductive: Paternal effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count) FAATDF 10,525,1988
oral
rat 		lowest published toxic dose: 2,586 mg/kg (6-15 pregnant) Reproductive: Effects on embryo or fetus: Fetal death NTIS** #PB86-108172
oral
rat 		lowest published toxic dose: 2,175 mg/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) NTIS** #PB86-108172
subcutaneous
rat 		lowest published toxic dose: 1,700 mg/kg (1-17 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system AIPTAK 172,219,1968


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
intramuscular
child 		lowest published toxic dose: 50 mg/kg Behavioral: Excitement

Cardiac: Change in rate

Lung, Thorax, or Respiration: Respiratory stimulation 		JOPDAB 90,827,1977
intramuscular
mouse 		lethal dose (50 percent kill): 271 mg/kg N/R NIIRDN 6,34,1982
intraperitoneal
mouse 		lethal dose (50 percent kill): 70 mg/kg Behavioral: Convulsions or effect on seizure threshold BJPCBM 73,887,1981
intraperitoneal
mouse 		lowest published toxic dose: 0.25 mg/kg Behavioral: Analgesia EURNE* 13,165,2003
intraperitoneal
rat 		lethal dose (50 percent kill): 150 mg/kg N/R USXXAM #4120947
intraperitoneal
rat 		lowest published toxic dose: 80 µg/kg Behavioral: Alteration of classical conditioning EURNE* 12,S66,2002
intraperitoneal
rat 		lowest published toxic dose: 80 µg/kg Brain and Coverings: Changes in surface EEG

Behavioral: Change in motor activity (specific assay) 		EURNE* 12,S67,2002
intravenous
human 		lowest published toxic dose: 10 mg/kg/ day Behavioral: Tremor

Cardiac: Arrythmias (indlucing changes in conduction)

Gastrointestinal: Nausea or vomiting 		JAMAAP 235,1983,1976
intravenous
man 		lowest published lethal dose: 3,429 µg/kg Behavioral: Convulsions or effect on seizure threshold

Lung, Thorax, or Respiration: Cyanosis

Gastrointestinal: Changes in structure or function of salivary glands 		JAMAAP 136,397,1948
intravenous
mouse 		lethal dose (50 percent kill): 136 mg/kg N/R PAHEAA 48,133,1973
intravenous
rat 		lowest published lethal dose: 240 mg/kg N/R 27ZIAQ -,259,1973
intravenous
rat 		lowest published toxic dose: 5 mg/kg Cardiac: Pulse rate increased without fall in BP

Vascular: BP elevation not characterized in autonomic section 		BPBLEO 24,1137,2001
intravenous
rat 		lowest published toxic dose: 10 mg/kg Lung, Thorax, or Respiration: Respiratory stimulation TOXID9 72,301,2003
intravenous
rat 		lowest published toxic dose: 3 mg/kg Behavioral: Alteration of operant conditioning NEROEW 26,422,2002
intravenous
rabbit 		lethal dose (50 percent kill): 150 mg/kg N/R NIIRDN 6,34,1982
intravenous
woman 		lowest published toxic dose: 120 mg/kg/3 day- continuous Cardiac: EKG changes not diagnostic of above

Biochemical: Metabolism (intermediary): Other 		DICPBB 16,877,1982
oral
child 		lowest published toxic dose: 10 mg/kg Behavioral: Headache

Cardiac: Pulse rate increased without fall in BP

Gastrointestinal: Nausea or vomiting 		SMJOAV 78,1000,1985
oral
guinea pig 		lethal dose (50 percent kill): 183 mg/kg N/R USXXAM #4089959
oral
guinea pig 		lowest published toxic dose: 27 mg/kg Lung, Thorax, or Respiration: Bronchiolar dilation JPETAB 297,165,2001
oral
guinea pig 		lowest published toxic dose: 100 mg/kg Lung, Thorax, or Respiration: Bronchiolar constriction, including asthma JPETAB 302,127,2002
oral
human 		lowest published toxic dose: 5 mg/kg Behavioral: Convulsions or effect on seizure threshold

Gastrointestinal: Nausea or vomiting

Nutritional and Gross Metabolic: Body temperature decrease 		34ZIAG -,92,1969
oral
human 		lowest published toxic dose: 7.14 mg/kg Brain and Coverings: Changes in surface EEG

Behavioral: Change in psychophysiological tests 		NEROEW 27,629,2002
oral
infant 		lowest published toxic dose: 348 mg/kg/4 day- intermittent Behavioral: Anorexia (human)

Behavioral: Irritability

Lung, Thorax, or Respiration: Respiratory stimulation 		PPHAD4 5,209,1985
oral
man 		lowest published toxic dose: 66 mg/kg Cardiac: Change in rate

Vascular: BP lowering not characterized in autonomic section

Gastrointestinal: Nausea or vomiting 		AJEMEN 11,609,1993
oral
man 		lowest published toxic dose: 66 mg/kg Behavioral: Muscle contraction or spasticity

Gastrointestinal: Nausea or vomiting

Gastrointestinal: Contraction (isolated tissue) 		MJAUAJ 156,512,1992
oral
man 		lowest published toxic dose: 129 mg/kg Endocrine: Hyperglycemia

Nutritional and Gross Metabolic: Changes in: K

Nutritional and Gross Metabolic: Changes in: Metabolic acidosis 		AIMEAS 104,284,1986
oral
man 		lowest published toxic dose: 86 mg/kg Cardiac: Change in rate

Vascular: BP lowering not characterized in autonomic section

Lung, Thorax, or Respiration: Respiratory stimulation 		AEMED3 20,1143,1991
oral
mouse 		lethal dose (50 percent kill): 235 mg/kg N/R ARZNAD 45,569,1995
oral
rat 		lethal dose (50 percent kill): 225 mg/kg N/R USXXAM #4089959
oral
rabbit 		lethal dose (50 percent kill): 350 mg/kg N/R 85JCAE -,865,1986
oral
woman 		lowest published toxic dose: 108 mg/kg Endocrine: Hyperglycemia

Nutritional and Gross Metabolic: Changes in: K

Nutritional and Gross Metabolic: Changes in: Metabolic acidosis 		AJEMEN 3,408,1985
oral
woman 		lowest published toxic dose: 388 mg/kg Behavioral: Coma

Cardiac: Change in rate

Nutritional and Gross Metabolic: Changes in: Metabolic acidosis 		AEMED3 20,1135,1991
oral
woman 		lowest published toxic dose: 5 mg/kg Behavioral: Coma

Cardiac: Arrythmias (indlucing changes in conduction)

Gastrointestinal: Nausea or vomiting 		BMJOAE 288,1497,1984
oral
woman 		lowest published lethal dose: 130 mg/kg Biochemical: Metabolism (intermediary): Other AIMEAS 101,457,1984
oral
woman 		lowest published toxic dose: 281 mg/kg/4 week Behavioral: Somnolence (general depressed activity) BMJOAE 281,1322,1980
parenteral
man 		lowest published lethal dose: 12 mg/kg N/R DAKMAJ 80,510,1904
rectal
human 		lowest published toxic dose: 6 mg/kg Behavioral: Convulsions or effect on seizure threshold

Gastrointestinal: Nausea or vomiting

Nutritional and Gross Metabolic: Body temperature decrease 		34ZIAG -,92,1969
rectal
mouse 		lethal dose (50 percent kill): 166 mg/kg Behavioral: Convulsions or effect on seizure threshold

Behavioral: Muscle contraction or spasticity

Lung, Thorax, or Respiration: Other changes 		PEREBL 11,783,1977
subcutaneous
guinea pig 		lowest published lethal dose: 170 mg/kg N/R HBTXAC 5,168,1959
subcutaneous
human 		lowest published toxic dose: 3,500 µg/kg Behavioral: Convulsions or effect on seizure threshold

Gastrointestinal: Nausea or vomiting

Nutritional and Gross Metabolic: Body temperature decrease 		34ZIAG -,92,1969
subcutaneous
mouse 		lethal dose (50 percent kill): 138 mg/kg N/R ARZNAD 3,328,1953
subcutaneous
rat 		lowest published lethal dose: 325 mg/kg N/R EPXXDW #0134762
unreported route
mouse 		lethal dose (50 percent kill): 400 mg/kg N/R USXXAM #4767763
unreported route
rat 		lethal dose (50 percent kill): 300 mg/kg N/R USXXAM #4767763


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
oral
human 		lowest published toxic dose: 160 mg/kg/4 week- intermittent Lung, Thorax, or Respiration: Other changes

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation 		CYLPDN 22,475,2001
oral
mouse 		lowest published toxic dose: 4,800 mg/kg/2 week- intermittent Eye: Other eye effects

Behavioral: Somnolence (general depressed activity)

Related to Chronic Data: Death in the "MULTIPLE DOSE" data type field 		FAATDF 10,477,1988
oral
mouse 		lowest published toxic dose: 10,350 mg/kg/13 week- intermittent Brain and Coverings: Changes in brain weight

Liver: Other changes

Blood: Pigmented or nucleated red blood cells 		FAATDF 11,472,1988
oral
mouse 		lowest published toxic dose: 38,625 mg/kg/103 week- intermittent Liver: Tumors

Tumorigenic: Active as anti-cancer agent 		NTIS** PB99-113342
oral
mouse 		lowest published toxic dose: 4,410 mg/kg/35 day- continuous Skin and Appendages: Other: Hair NTIS** #PB85204659/AS
oral
mouse 		lowest published toxic dose: 73,500 mg/kg/21 week- continuous Liver: Changes in liver weight

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		NTIS** #PB85204659/AS
oral
mouse 		lowest published toxic dose: 73,500 mg/kg/21 week- continuous Reproductive: Paternal effects: Testes, epididymis, sperm duct

Reproductive: Paternal effects: Prostate, seminal vesicle, Cowper's gland, accessory glands

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		NTIS** #PB85204659/AS
oral
rat 		lowest published toxic dose: 600 mg/kg/2 week- intermittent Lung, Thorax, or Respiration: Respiratory stimulation

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		FAATDF 10,477,1988
oral
rat 		lowest published toxic dose: 5,175 mg/kg/13 week- intermittent Liver: Changes in liver weight

Kidney, Ureter, and Bladder: Urine volume increased

Blood: Changes in leukocyte (WBC) count 		FAATDF 11,472,1988
oral
rat 		lowest published toxic dose: 39,900 mg/kg/19 week- continuous Nutritional and Gross Metabolic: Weight loss or decreased weight gain JEPTDQ 2(3),687,1979
oral
rat 		lowest published toxic dose: 3,500 mg/kg/5 week- intermittent Cardiac: Other changes

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Other transferases 		TXCYAC 145,185,2000
oral
rat 		lowest published toxic dose: 12,875 mg/kg/103 week- intermittent Skin and Appendages: Tumors

Tumorigenic: Active as anti-cancer agent 		NTIS** PB99-113342
oral
rat 		lowest published toxic dose: 12,000 mg/kg/48 week- continuous Brain and Coverings: Tumors

Tumorigenic: Protects against induction of experimental tumors

Tumorigenic: Active as anti-cancer agent 		EXONC* 15,23,1993
oral
rat 		lowest published toxic dose: 9,600 mg/kg/32 week- continuous Gastrointestinal: Tumors

Tumorigenic: Protects against induction of experimental tumors

Tumorigenic: Active as anti-cancer agent 		EXONC* 15,23,1993
oral
rat 		lowest published toxic dose: 1,238 mg/kg/10 day- continuous Skin and Appendages: Other: Hair

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		NTIS** #PB86-108172
oral
rat 		lowest published toxic dose: 2,586 mg/kg/10 day- continuous Nutritional and Gross Metabolic: Weight loss or decreased weight gain NTIS** #PB86-108172
oral
rat 		lowest published toxic dose: 2,175 mg/kg/10 day- continuous Behavioral: Food intake (animal) NTIS** #PB86-108172
oral
rat 		lowest published toxic dose: 1,238 mg/kg/10 day- continuous Behavioral: Fluid intake NTIS** #PB86-108172
unreported route
mouse 		lowest published toxic dose: 2,160 mg/kg/3 day- intermittent Related to Chronic Data: Death in the "MULTIPLE DOSE" data type field FATOAO 49,74,1986


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
International Agency for Research on Cancer (IARC) Cancer Review Human Inadequate Evidence IMEMDT 51,391,1991
International Agency for Research on Cancer (IARC) Cancer Review Animal Inadequate Evidence IMEMDT 51,391,1991
International Agency for Research on Cancer (IARC) Cancer Review Group 3 IMEMDT 51,391,1991
TOXICOLOGY REVIEW
JRPMAP 12,27,1974
TOXICOLOGY REVIEW
FAATDF 13,747,1989
TOXICOLOGY REVIEW
JTSCDR 25,1,2000
TOXICOLOGY REVIEW
MUREAV 488,151,2001
TOXICOLOGY REVIEW
MUREAV 5432012003
TOXICOLOGY REVIEW
TOLED5 144,383,2003
TOXICOLOGY REVIEW
TPHSDY 23,83,2002


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
N/R N/R N/R


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: M0977;
Number of Industries 3;
Total Number of Facilities 1,681;
Number of Occupations 18;
Total Number of Employees Exposed 7,418
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: M0977;
Number of Industries 6;
Total Number of Facilities 1,091;
Number of Occupations 13;
Total Number of Employees Exposed 29,718;
Total Number of Female Employees Exposed 21,742


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
EPA TSCA Section 8(b) CHEMICAL INVENTORY
Used as a diuretic, cardiac stimulant, smooth muscle relaxant
NCI Carcinogenesis Studies (gavage);no evidence:mouse,rat


REFERENCES:

CODEN
REFERENCE
27ZIAQ "Drug Dosages in Laboratory Animals - A Handbook," Rev. ed., Barnes, C.D., and L.G. Eltherington, Berkeley, Univ. of California Press, 1973
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Used as a diuretic, cardiac stimulant, smooth muscle relaxant

FDA-over the counter drug

RTECS Compound Description:
   Tumorigen
   Drug
   Mutagen
   Reproductive Effector
   Human Data

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