*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : XH3850000
CHEMICAL NAME : Theophylline
CAS REGISTRY NUMBER : 58-55-9
LAST UPDATED : 199801
DATA ITEMS CITED : 81
MOLECULAR FORMULA : C7-H8-N4-O2
MOLECULAR WEIGHT : 180.19
WISWESSER LINE NOTATION : T56 BM DN FNVNVJ F1 H1
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Acet-theocin
* Armophylline
* Asmax
* Austyn
* 3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione
* 1,3-Dimethylxanthine
* Duraphy
* Elixicon
* Elixophyllin
* Elixophylline
* Euphylong
* Lanophyllin
* Liquophylline
* NSC 2066
* Nuelin
* Optiphyllin
* Parkophyllin
* Pseudotheophylline
* 1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-
* Quibron T/SR
* Slo-Phyllin
* Solosin
* Spophyllin retard
* Teofilina
* Teofyllamin
* Theal tablets
* Theocin
* Theo-Dur
* Theofol
* Theograd
* Theolair
* Theolix
* Theophyl-225
* Theophyllin
* Theophylline, anhydrous
* Uniphyllin
* Xanthine, 1,3-dimethyl-
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 66 mg/kg
TOXIC EFFECTS :
Cardiac - change in rate
Vascular - BP lowering not characterized in autonomic section
Gastrointestinal - nausea or vomiting
REFERENCE :
AJEMEN American Journal of Emergency Medicine. (WB Saunders, Philadelphia,
PA) V.1- 1983- Volume(issue)/page/year: 11,609,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 108 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 : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 388 mg/kg
TOXIC EFFECTS :
Behavioral - coma
Cardiac - change in rate
Nutritional and Gross Metabolic - metabolic acidosis
REFERENCE :
AEMED3 Annals of Emergency Medicine. (American College of Emergency
Physicians, 1125 Executive Circle, Irving, TX 75038)
Volume(issue)/page/year: 20,1135,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - infant
DOSE/DURATION : 348 mg/kg/4D-I
TOXIC EFFECTS :
Behavioral - anorexia (human)
Behavioral - irritability
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
PPHAD4 Pediatric Pharmacology. (New York, NY) V.1-5, 1980-86. For
publisher information, see DPTHDL. Volume(issue)/page/year: 5,209,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 5 mg/kg
TOXIC EFFECTS :
Behavioral - coma
Cardiac - arrhythmias (including changes in conduction)
Gastrointestinal - nausea or vomiting
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
288,1497,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human
DOSE/DURATION : 5 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Gastrointestinal - nausea or vomiting
Nutritional and Gross Metabolic - body temperature decrease
REFERENCE :
34ZIAG "Toxicology of Drugs and Chemicals," Deichmann, W.B., New York,
Academic Press, Inc., 1969 Volume(issue)/page/year: -,92,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 66 mg/kg
TOXIC EFFECTS :
Behavioral - muscle contraction or spasticity
Gastrointestinal - nausea or vomiting
Gastrointestinal - contraction (isolated tissue)
REFERENCE :
MJAUAJ Medical Journal of Australia. (Australasian Medical Pub. Co. Ltd.,
71-79 Arundel St., Glebe, N.S.W., Australia) V.1- 1914-
Volume(issue)/page/year: 156,512,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 129 mg/kg
TOXIC EFFECTS :
Endocrine - hyperglycemia
Nutritional and Gross Metabolic - changes in potassium
Nutritional and Gross Metabolic - metabolic acidosis
REFERENCE :
AIMEAS Annals of Internal Medicine. (American College of Physicians, 4200
Pine St., Philadelphia, PA 19104) V.1- 1927- Volume(issue)/page/year:
104,284,1986
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 130 mg/kg
TOXIC EFFECTS :
Biochemical - Metabolism (Intermediary) - other
REFERENCE :
AIMEAS Annals of Internal Medicine. (American College of Physicians, 4200
Pine St., Philadelphia, PA 19104) V.1- 1927- Volume(issue)/page/year:
101,457,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 86 mg/kg
TOXIC EFFECTS :
Cardiac - change in rate
Vascular - BP lowering not characterized in autonomic section
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
AEMED3 Annals of Emergency Medicine. (American College of Emergency
Physicians, 1125 Executive Circle, Irving, TX 75038)
Volume(issue)/page/year: 20,1143,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 281 mg/kg/4W
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
281,1322,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 10 mg/kg
TOXIC EFFECTS :
Behavioral - headache
Cardiac - pulse rate increase, without fall in BP
Gastrointestinal - nausea or vomiting
REFERENCE :
SMJOAV Southern Medical Journal. (Southern Medical Assoc., POB 2446,
Birmingham, AL 35205) V.1- 1908- Volume(issue)/page/year: 78,1000,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Human
DOSE/DURATION : 3500 ug/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Gastrointestinal - nausea or vomiting
Nutritional and Gross Metabolic - body temperature decrease
REFERENCE :
34ZIAG "Toxicology of Drugs and Chemicals," Deichmann, W.B., New York,
Academic Press, Inc., 1969 Volume(issue)/page/year: -,92,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human
DOSE/DURATION : 10 mg/kg/D
TOXIC EFFECTS :
Behavioral - tremor
Cardiac - arrhythmias (including changes in conduction)
Gastrointestinal - nausea or vomiting
REFERENCE :
JAMAAP JAMA, Journal of the American Medical Association. (AMA, 535 N.
Dearborn St., Chicago, IL 60610) V.1- 1883- Volume(issue)/page/year:
235,1983,1976
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - man
DOSE/DURATION : 3429 ug/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Lungs, Thorax, or Respiration - cyanosis
Gastrointestinal - changes in structure or function of salivary glands
REFERENCE :
JAMAAP JAMA, Journal of the American Medical Association. (AMA, 535 N.
Dearborn St., Chicago, IL 60610) V.1- 1883- Volume(issue)/page/year:
136,397,1948
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Human - child
DOSE/DURATION : 50 mg/kg
TOXIC EFFECTS :
Behavioral - excitement
Cardiac - change in rate
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
90,827,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 120 mg/kg/3D-C
TOXIC EFFECTS :
Cardiac - EKG changes not diagnostic of specified effects
Biochemical - Metabolism (Intermediary) - other
REFERENCE :
DICPBB Drug Intelligence and Clinical Pharmacy. (POB 42435, Cincinnati, OH
45242) V.3- 1969- Volume(issue)/page/year: 16,877,1982
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 12 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
DAKMAJ Deutsches Archiv fuer Klinische Medizin. (Leipzig, Ger. Dem. Rep.)
V.1-211, 1865-1965. For publisher information, see EJCIB8.
Volume(issue)/page/year: 80,510,1904
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Rectal
SPECIES OBSERVED : Human
DOSE/DURATION : 6 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Gastrointestinal - nausea or vomiting
Nutritional and Gross Metabolic - body temperature decrease
REFERENCE :
34ZIAG "Toxicology of Drugs and Chemicals," Deichmann, W.B., New York,
Academic Press, Inc., 1969 Volume(issue)/page/year: -,92,1969
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 225 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #4089959
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 188 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - muscle contraction or spasticity
Lungs, Thorax, or Respiration - other changes
REFERENCE :
PEREBL Pediatric Research. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1967- Volume(issue)/page/year: 11,783,1977
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 325 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
EPXXDW European Patent Application. (U.S. Patent and Trademark Office,
Foreign Patents, Washington, DC 20231) Volume(issue)/page/year: #0134762
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 240 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
27ZIAQ "Drug Dosages in Laboratory Animals - A Handbook," Rev. ed., Barnes,
C.D., and L.G. Eltherington, Berkeley, Univ. of California Press, 1973
Volume(issue)/page/year: -,259,1973
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 235 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: 45,569,1995
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 70 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
REFERENCE :
BJPCBM British Journal of Pharmacology. (Macmillan Press Ltd., Houndmills,
Basingstoke, Hants. RG21 2XS, UK) V.34- 1968- Volume(issue)/page/year:
73,887,1981
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 138 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: 3,328,1953
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 136 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
PAHEAA Pharmaceutica Acta Helvetiae. (Schweizerische Apothekerzeitung,
Postfach 3006, CH3000 Bern, 7, Switzerland) V.1- 1926-
Volume(issue)/page/year: 48,133,1973
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 271 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,34,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Rectal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 166 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - muscle contraction or spasticity
Lungs, Thorax, or Respiration - other changes
REFERENCE :
PEREBL Pediatric Research. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1967- Volume(issue)/page/year: 11,783,1977
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 350 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
85JCAE "Prehled Prumyslove Toxikologie; Organicke Latky," Marhold, J.,
Prague, Czechoslovakia, Avicenum, 1986 Volume(issue)/page/year: -,865,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 150 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,34,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 183 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #4089959
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 170 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
HBTXAC "Handbook of Toxicology," 4 vols., Philadelphia, W.B. Saunders Co.,
1956-59 Volume(issue)/page/year: 5,168,1959
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 600 mg/kg/2W-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - respiratory stimulation
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
10,477,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 5175 mg/kg/13W-I
TOXIC EFFECTS :
Liver - changes in liver weight
Kidney, Ureter, Bladder - urine volume increased
Blood - changes in leukocyte (WBC) count
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
11,472,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 39900 mg/kg/19W-C
TOXIC EFFECTS :
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
JEPTDQ Journal of Environmental Pathology and Toxicology. (Park Forest
South, IL) V.1-5(3), 1977-81(?). For publisher information, see JEPOEC.
Volume(issue)/page/year: 2(3),687,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 4800 mg/kg/2W-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - effect, not otherwise specified
Behavioral - somnolence (general depressed activity)
Related to Chronic Data - death
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
10,477,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 10350 mg/kg/13W-I
TOXIC EFFECTS :
Brain and Coverings - changes in brain weight
Liver - other changes
Blood - pigmented or nucleated red blood cells
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
11,472,1988
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 10050 mg/kg
SEX/DURATION : male 67 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
10,525,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1500 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: 33,70C,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 75335 mg/kg
SEX/DURATION : male 95 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
10,525,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 1700 mg/kg
SEX/DURATION : female 1-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
AIPTAK Archives Internationales de Pharmacodynamie et de Therapie. (Heymans
Institute of Pharmacology, De Pintelaan 185, B-9000 Ghent, Belgium) V.4-
1898- Volume(issue)/page/year: 172,219,1968
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 3 gm/kg
SEX/DURATION : female 6-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - 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
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: PB86-103223
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 4375 mg/kg
SEX/DURATION : male 7 day(s) pre-mating
female 7 day(s) pre-mating - 3 week(s) after
conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
10,525,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 3720 mg/kg
SEX/DURATION : female 6-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - 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)
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
14,167,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE : 175 mg/kg
SEX/DURATION : female 13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
Reproductive - Specific Developmental Abnormalities - body wall
REFERENCE :
OFAJAE Okajimas Folia Anatomica Japonica. (Keio Univ., School of Medicine,
Dept. of Anatomy, 35 Shinano-machi, Shinjuku-ku, Tokyo 160, Japan) V.14-
1936- Volume(issue)/page/year: 46,167,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE : 200 mg/kg
SEX/DURATION : female 13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
Reproductive - Specific Developmental Abnormalities - other developmental
abnormalities
REFERENCE :
OFAJAE Okajimas Folia Anatomica Japonica. (Keio Univ., School of Medicine,
Dept. of Anatomy, 35 Shinano-machi, Shinjuku-ku, Tokyo 160, Japan) V.14-
1936- Volume(issue)/page/year: 46,167,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE : 225 mg/kg
SEX/DURATION : female 13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
REFERENCE :
OFAJAE Okajimas Folia Anatomica Japonica. (Keio Univ., School of Medicine,
Dept. of Anatomy, 35 Shinano-machi, Shinjuku-ku, Tokyo 160, Japan) V.14-
1936- Volume(issue)/page/year: 46,167,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 18750 ug/kg
SEX/DURATION : female 24-26 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - other neonatal measures or effects
REFERENCE :
PEREBL Pediatric Research. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1967- Volume(issue)/page/year: 12,38,1978
** MUTATION DATA **
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 150 mg/L
REFERENCE :
CSHSAZ Cold Spring Harbor Symposia on Quantitative Biology. (Cold Spring
Harbor Laboratory, POB 100, Cold Spring Harbor, NY 11724) V.1- 1933-
Volume(issue)/page/year: 16,337,1952
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Bacteria - Bacillus subtilis
DOSE/DURATION : 7500 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 117,55,1983
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Microorganism - not otherwise specified
DOSE/DURATION : 6000 ppm
REFERENCE :
NATUAS Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736)
V.1- 1869- Volume(issue)/page/year: 162,573,1948
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Protozoa - Euglena gracilis
DOSE/DURATION : 600 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 32,169,1975
TYPE OF TEST : Unscheduled DNA synthesis
TEST SYSTEM : Human Cells - not otherwise specified
DOSE/DURATION : 1 mmol/L
REFERENCE :
BIOJAU Biophysical Journal. (Rockefeller Univ. Press, 1230 York Ave., New
York, NY 10021) V.1- 1960- Volume(issue)/page/year: 35,665,1981
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Human Fibroblast
DOSE/DURATION : 7 mg/L
REFERENCE :
NEOLA4 Neoplasma. (Karger-Libri, P.O. Box, CH-4009 Basel, Switzerland) V.4-
1957- Volume(issue)/page/year: 33,699,1986
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Human Cells - not otherwise specified
DOSE/DURATION : 4 mmol/L
REFERENCE :
BIOJAU Biophysical Journal. (Rockefeller Univ. Press, 1230 York Ave., New
York, NY 10021) V.1- 1960- Volume(issue)/page/year: 35,665,1981
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 100 umol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 15,197,1972
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 10 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 224,409,1989
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Human Embryo
DOSE/DURATION : 360 mg/L
REFERENCE :
SNSHBT Senshokutai. Chromosome. (Sensyokutai Gakkai, Kaokusai Kirisutokyo
Daigaku, Mitaka, Tokyo-to, Japan) No.1- 1946- Adopted new numbering
in 1976. Volume(issue)/page/year: (20),574,1980
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 10 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 224,409,1989
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 360 mg/L
REFERENCE :
SNSHBT Senshokutai. Chromosome. (Sensyokutai Gakkai, Kaokusai Kirisutokyo
Daigaku, Mitaka, Tokyo-to, Japan) No.1- 1946- Adopted new numbering
in 1976. Volume(issue)/page/year: (20),574,1980
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 6 mmol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 26,73,1974
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Rodent - mouse Fibroblast
DOSE/DURATION : 6 mmol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 26,73,1974
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Rodent - rat Cells - not otherwise specified
DOSE/DURATION : 1 mmol/L
REFERENCE :
INOPAO Investigative Ophthalmology. (St. Louis, MO) V.1-15, 1962-76. For
publisher information, see IOVSDA. Volume(issue)/page/year: 13,210,1974
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Rodent - mouse Cells - not otherwise specified
DOSE/DURATION : 100 umol/L
REFERENCE :
JIDEAE Journal of Investigative Dermatology. (Williams & Wilkins Co., 428
E. Preston St., Baltimore, MD 21202) V.1- 1938- Volume(issue)/page/year:
66,313,1976
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - mouse Mammary gland
DOSE/DURATION : 3200 umol/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
TYPE OF TEST : Sister chromatid exchange
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 125 mg/kg
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 264,219,1991
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 6 mmol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 26,73,1974
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 450 mg/L
REFERENCE :
GMCRDC Gann Monograph on Cancer Research. (Plenum Pub. Corp., 233 Spring
St., New York, NY 10013) No. 11- 1971- Volume(issue)/page/year:
27,95,1981
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Rodent - hamster Ovary
DOSE/DURATION : 2 mmol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 126,63,1984
TYPE OF TEST : Sister chromatid exchange
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - hamster
DOSE/DURATION : 300 mg/kg
REFERENCE :
EXPEAM Experientia. (Birkhaeuser Verlag, POB 133, CH-4010 Basel,
Switzerland) V.1- 1945- Volume(issue)/page/year: 38,600,1982
TYPE OF TEST : Mutation in mammalian somatic cells
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 7 mg/L
REFERENCE :
NEOLA4 Neoplasma. (Karger-Libri, P.O. Box, CH-4009 Basel, Switzerland) V.4-
1957- Volume(issue)/page/year: 33,699,1986
*** REVIEWS ***
IARC Cancer Review:Human Inadequate Evidence
IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
V.1- 1972- Volume(issue)/page/year: 51,391,1991
IARC Cancer Review:Animal Inadequate Evidence
IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
V.1- 1972- Volume(issue)/page/year: 51,391,1991
IARC Cancer Review:Group 3
IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
V.1- 1972- Volume(issue)/page/year: 51,391,1991
TOXICOLOGY REVIEW
JRPMAP Journal of Reproductive Medicine. (2 Jacklynn Ct., St. Louis, MO
63132) V.3- 1969- Volume(issue)/page/year: 12,27,1974
TOXICOLOGY REVIEW
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
13,747,1989
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOHS - National Occupational Hazard Survey (1974)
NOHS Hazard Code - M0977
No. of Facilities: 1681 (estimated)
No. of Industries: 3
No. of Occupations: 18
No. of Employees: 7418 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - M0977
No. of Facilities: 1091 (estimated)
No. of Industries: 6
No. of Occupations: 13
No. of Employees: 29718 (estimated)
No. of Female Employees: 21742 (estimated)
*** STATUS IN U.S. ***
EPA TSCA Section 8(b) CHEMICAL INVENTORY
NTP Carcinogenesis studies; test completed (post peer review), October 1997
*** END OF RECORD ***