*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : HN8225000
CHEMICAL NAME : 5H-Dibenz(b,f)azepine-5-carboxamide
CAS REGISTRY NUMBER : 298-46-4
BEILSTEIN REFERENCE NO. : 1246090
REFERENCE : 5-20-08-00247 (Beilstein Handbook Reference)
LAST UPDATED : 199706
DATA ITEMS CITED : 40
MOLECULAR FORMULA : C15-H12-N2-O
MOLECULAR WEIGHT : 236.29
WISWESSER LINE NOTATION : T C676 BNJ BVZ
COMPOUND DESCRIPTOR : Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Amizepin
* Biston
* Carbamazepen
* Carbamazepine
* 5-Carbamoyl-5H-dibenz(b,f)azepine
* 5-Carbamoyl-5H-dibenzo(b,f)azepine
* 5-Carbamyl-5H-dibenzo(b,f)azepine
* Carbazepine
* Finlepsin
* G 32883
* Geigy 32883
* Karbamazepin
* Neurotol
* Stazepine
* Tegretal
* Tegretol
* Telesmin
* Timonil
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 112 mg/kg/2W-I
TOXIC EFFECTS :
Gastrointestinal - nausea or vomiting
Blood - thrombocytopenia
REFERENCE :
AJPSAO American Journal of Psychiatry. (American Psychiatric Assoc.,
Circulation Dept., 1400 K St., NW, Washington, DC 20005) V.78- 1921-
Volume(issue)/page/year: 150,1750,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 65 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - coma
Lungs, Thorax, or Respiration - other changes
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
121,295,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 144 mg/kg/2W-I
TOXIC EFFECTS :
Blood - thrombocytopenia
Skin and Appendages - dermatitis, allergic (after systemic exposure)
REFERENCE :
JCLPDE Journal of Clinical Psychiatry. (Physicians Postgraduate Press,
Inc., POB 240008, Memphis, TN 38124) V.39- 1978-
Volume(issue)/page/year: 53,378,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 160 mg/kg/3W-I
TOXIC EFFECTS :
Skin and Appendages - dermatitis, other (after systemic exposure)
REFERENCE :
JCPYDR Journal of Clinical Pyschopharmacology. (Williams & Wilkins Co., 428
E. Preston St., Baltimore, MD 21202) V.1- 1981- Volume(issue)/page/year:
5,185,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 1050 mg/kg/6W-I
TOXIC EFFECTS :
Behavioral - muscle contraction or spasticity
REFERENCE :
AJPSAO American Journal of Psychiatry. (American Psychiatric Assoc.,
Circulation Dept., 1400 K St., NW, Washington, DC 20005) V.78- 1921-
Volume(issue)/page/year: 143,1176,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 253 mg/kg/6W-I
TOXIC EFFECTS :
Gastrointestinal - nausea or vomiting
Liver - liver function tests impaired
REFERENCE :
JCPYDR Journal of Clinical Pyschopharmacology. (Williams & Wilkins Co., 428
E. Preston St., Baltimore, MD 21202) V.1- 1981- Volume(issue)/page/year:
6,251,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 19 mg/kg/4W-I
TOXIC EFFECTS :
Peripheral Nerve and Sensation - fasciculations
REFERENCE :
PEDIAU Pediatrics. (American Academy of Pediatrics, P.O. Box 1034,
Evanston, IL 60204) V.1- 1948- Volume(issue)/page/year: 73,841,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 28 mg/kg/4D-I
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Gastrointestinal - nausea or vomiting
Nutritional and Gross Metabolic - other changes
REFERENCE :
AJPSAO American Journal of Psychiatry. (American Psychiatric Assoc.,
Circulation Dept., 1400 K St., NW, Washington, DC 20005) V.78- 1921-
Volume(issue)/page/year: 143,1328,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human
DOSE/DURATION : 43 mg/kg
TOXIC EFFECTS :
Behavioral - sleep
Behavioral - hallucinations, distorted perceptions
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:
1,754,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 560 mg/kg/4W-I
TOXIC EFFECTS :
Blood - changes in bone marrow (not otherwise specified)
REFERENCE :
BJCPAT British Journal of Clinical Practice. (Medical News Group, 1 Bedford
St., London WC2E 9HD, UK) V.10(10)- 1956- Volume(issue)/page/year:
43,302,1989
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 54 mg/kg/9D-I
TOXIC EFFECTS :
Behavioral - ataxia
Kidney, Ureter, Bladder - urine volume increased
Blood - agranulocytosis
REFERENCE :
CMAJAX Canadian Medical Association Journal. (Canadian Medical Assoc., POB
8650, Ottawa, ON K1G 0G8, Canada) V.1- 1911- Volume(issue)/page/year:
132,1040,1985
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 1920 mg/kg/17W-I
TOXIC EFFECTS :
Blood - aplastic anemia
REFERENCE :
AJPSAO American Journal of Psychiatry. (American Psychiatric Assoc.,
Circulation Dept., 1400 K St., NW, Washington, DC 20005) V.78- 1921-
Volume(issue)/page/year: 142,974,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 94 mg/kg/11D-I
TOXIC EFFECTS :
Blood - thrombocytopenia
REFERENCE :
JCPYDR Journal of Clinical Pyschopharmacology. (Williams & Wilkins Co., 428
E. Preston St., Baltimore, MD 21202) V.1- 1981- Volume(issue)/page/year:
10,305,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1957 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
REFERENCE :
JKXXAF Japanese Kokai Tokyo Koho Patents. (U.S. Patent and Trademark
Office, Foreign Patents, Washington, DC 20231) Volume(issue)/page/year:
#79-163823
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 158 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
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: 202,106,1973
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >1500 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: 30,477,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 529 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
FRMCE8 Farmaco. (Societa Chimica Italiana, Corso Strada Nova, 86, Casella
Postale 227, 27100 Pavia, Italy) V.44- 1989- Volume(issue)/page/year:
44,595,1989
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 114 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
FATOAO Farmakologiya i Toksikologiya (Moscow). For English translation, see
PHTXA6 and RPTOAN. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.2-
1939- Volume(issue)/page/year: 53(4),19,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >1 gm/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: 30,477,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 5620 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
27ZQAG "Psychotropic Drugs and Related Compounds," 2nd ed., Usdin, E., and
D.H. Efron, Washington, DC, 1972 Volume(issue)/page/year: -,63,1972
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 2680 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
27ZQAG "Psychotropic Drugs and Related Compounds," 2nd ed., Usdin, E., and
D.H. Efron, Washington, DC, 1972 Volume(issue)/page/year: -,63,1972
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 920 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
27ZQAG "Psychotropic Drugs and Related Compounds," 2nd ed., Usdin, E., and
D.H. Efron, Washington, DC, 1972 Volume(issue)/page/year: -,63,1972
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 96 mg/kg
SEX/DURATION : female 3 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
REFERENCE :
OBGNAS Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1953- Volume(issue)/page/year:
82,705,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 3192 mg/kg
SEX/DURATION : female 1-38 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
Reproductive - Effects on Newborn - delayed effects
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
320,1661,1989
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 7644 mg/kg
SEX/DURATION : female 1-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - skin and skin
appendages
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
320,1661,1989
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1288 mg/kg
SEX/DURATION : female 26-42 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - skin and skin
appendages
REFERENCE :
NRPDDB Neuropediatrics (Stuttgart). (Hippokrates Verlag GmbH, Postfach 593,
D-7000 Stuttgart 1, Fed. Rep. Ger.) V.11- 1980- Volume(issue)/page/year:
16,167,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 3492 mg/kg
SEX/DURATION : female 1-39 week(s) after conception
lactating female 17 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - biochemical and metabolic
REFERENCE :
EJPEDT European Journal of Pediatrics. (Springer-Verlag New York, Inc.,
Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.121- 1975-
Volume(issue)/page/year: 150,136,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 3600 mg/kg
SEX/DURATION : female 14 day(s) pre-mating
female 1-22 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - live birth index (measured after birth)
Reproductive - Effects on Newborn - weaning or lactation index (e.g., #
alive at weaning per # alive at day 4)
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
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: 29(3),33A,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 765 mg/kg
SEX/DURATION : female 9-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
EAMJAV East African Medical Journal. (P.O. Box 41632, Nairobi, Kenya) V.9-
1932- Volume(issue)/page/year: 60,407,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 4800 mg/kg
SEX/DURATION : female 7-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - other developmental
abnormalities
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: 41,311,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 7200 mg/kg
SEX/DURATION : female 7-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
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: 41,311,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 2400 mg/kg
SEX/DURATION : female 7-18 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: 41,311,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 440 mg/kg
SEX/DURATION : female 6-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
40,365,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 92 gm/kg
SEX/DURATION : male 2 week(s) pre-mating
female 2 week(s) pre-mating - 18 day(s) after
conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
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 :
TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc.,
41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year:
6,393,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 5628 mg/kg
SEX/DURATION : female 7-12 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - eye/ear
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
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: 23,33A,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 9984 mg/kg
SEX/DURATION : female 8-13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
ARNEAS Archives of Neurology (Chicago). (AMA, 535 N. Dearborn St., Chicago,
IL 60610) V.3- 1960- Volume(issue)/page/year: 36,832,1979
*** REVIEWS ***
TOXICOLOGY REVIEW
HFHBAG Hartford Hospital Bulletin. (Hartford Hospital, 80 Seymour St.,
Hartford, CT 06115) V.1- 1938/39- Volume(issue)/page/year: 30,31,1975
TOXICOLOGY REVIEW
EPILAK Epilepsia (New York). (Raven Press, 1185 Ave. of the Americas, New
York, NY 10036) Ser.1-3: 1909-55; Ser.4: V.1- 1959-
Volume(issue)/page/year: 16,159,1975
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X4467
No. of Facilities: 169 (estimated)
No. of Industries: 2
No. of Occupations: 5
No. of Employees: 5295 (estimated)
No. of Female Employees: 3361 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Inconclusive: Histidine reversion-Ames test
*** END OF RECORD ***