*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : TH9000000
CHEMICAL NAME : Phthalazine, 1-hydrazino-, monohydrochloride
CAS REGISTRY NUMBER : 304-20-1
OTHER CAS REGISTRY NOS. : 40671-54-3
LAST UPDATED : 199806
DATA ITEMS CITED : 28
MOLECULAR FORMULA : C8-H8-N4.Cl-H
MOLECULAR WEIGHT : 196.66
WISWESSER LINE NOTATION : T66 CNNJ BMZ &GH
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
SYNONYMS/TRADE NAMES :
* Aiselazine
* Apresine
* Apresoline-esidrix
* Apresoline hydrochloride
* Hydralazine chloride
* Hydralazine monohydrochloride
* 1-Hydrazinophthalazine monohydrochloride
* Nor-press 25
* 1(2H)-Phthalazinone, hydrazone, monohydrochloride
* Praparat 5968
* Rolazine
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 280 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: -,1006,1995
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 34 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: 6,619,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 188 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 3,97,1969
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 83 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams &
Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10-
Volume(issue)/page/year: 101,368,1951
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 73 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - excitement
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
SIZSAR Sapporo Igaku Zasshi. Sapporo Medical Journal. (Sapporo Igaku
Daigaku, Nishi-17-chome, Minami-1-jo, Chuo-ku, Sapporo 060, Japan) V.3-
1952- Volume(issue)/page/year: 6,362,1954
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 71 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: -,1006,1995
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 59 mg/kg/2D-I
TOXIC EFFECTS :
Endocrine - hyperglycemia
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Nutritional and Gross Metabolic - changes in chlorine
REFERENCE :
TOPADD Toxicologic Pathology. (c/o Dr. F.A. de la Iglesia, Warner-Lambert
Co., Pharmaceutical Research Div., POB 1047, Ann Arbor, MI 48106) V.6(3/4)-
1978- Volume(issue)/page/year: 15,409,1987
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 2950 mg/kg/78W-C
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Lungs, Thorax, or Respiration - tumors
Blood - lymphoma, including Hodgkin's disease
REFERENCE :
JJIND8 JNCI, Journal of the National Cancer Institute. (Washington, DC)
V.61-79, 1978-87. For publisher information, see JNCIEQ.
Volume(issue)/page/year: 61,1363,1978
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 176 mg/kg
SEX/DURATION : female 1-22 day(s) after conception
TOXIC EFFECTS :
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: 34,469,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1100 mg/kg
SEX/DURATION : female 7-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 19,2503,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1100 mg/kg
SEX/DURATION : female 7-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - stillbirth
Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4
per # born alive)
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 19,2503,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 360 mg/kg
SEX/DURATION : female 8-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co.,
11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920-
Volume(issue)/page/year: 169,1027,1993
** MUTATION DATA **
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Bacteria - Salmonella typhimurium
DOSE/DURATION : 500 ug/plate
REFERENCE :
RCOCB8 Research Communications in Chemical Pathology and Pharmacology. (PJD
Pub. Ltd., P.O. Box 966, Westbury, NY 11590) V.1- 1970-
Volume(issue)/page/year: 49,415,1985
TYPE OF TEST : DNA repair
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 7500 ng/well
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 133,161,1984
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Human HeLa cell
DOSE/DURATION : 150 umol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 92,427,1982
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 1 mmol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 77,383,1980
TYPE OF TEST : DNA repair
TEST SYSTEM : Rodent - rat Liver
DOSE/DURATION : 10 umol/L
REFERENCE :
JJCREP Japanese Journal of Cancer Research. (Elsevier Science Pub. BV, POB
211, 1000 AE Amsterdam, Netherlands) V.76- 1985-
Volume(issue)/page/year: 79,204,1988
TYPE OF TEST : Unscheduled DNA synthesis
TEST SYSTEM : Rodent - rat Liver
DOSE/DURATION : 100 umol/L
REFERENCE :
RCOCB8 Research Communications in Chemical Pathology and Pharmacology. (PJD
Pub. Ltd., P.O. Box 966, Westbury, NY 11590) V.1- 1970-
Volume(issue)/page/year: 49,415,1985
TYPE OF TEST : DNA repair
TEST SYSTEM : Rodent - mouse Liver
DOSE/DURATION : 10 umol/L
REFERENCE :
JJCREP Japanese Journal of Cancer Research. (Elsevier Science Pub. BV, POB
211, 1000 AE Amsterdam, Netherlands) V.76- 1985-
Volume(issue)/page/year: 79,204,1988
TYPE OF TEST : DNA damage
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 83 mg/kg
REFERENCE :
ENMUDM Environmental Mutagenesis. (New York, NY) V.1-9, 1979-87. For
publisher information, see EMMUEG. Volume(issue)/page/year: 4,605,1982
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - mouse Mammary gland
DOSE/DURATION : 20 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 : 83 mg/kg
REFERENCE :
ENMUDM Environmental Mutagenesis. (New York, NY) V.1-9, 1979-87. For
publisher information, see EMMUEG. Volume(issue)/page/year: 4,605,1982
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 1 mg/L
REFERENCE :
AMONDS Applied Methods in Oncology. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1978- Volume(issue)/page/year:
3,253,1980
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - hamster Fibroblast
DOSE/DURATION : 7500 ug/L
REFERENCE :
ESKHA5 Eisei Shikenjo Hokoku. Bulletin of the Institute of Hygienic
Sciences. (Kokuritsu Eisei Shikenjo Kagaku, 18-1 Bushitsu Johobu,
Setagaya-ku, Tokyo 158, Japan) V.1- 1886- Volume(issue)/page/year:
(96),55,1978
*** REVIEWS ***
IARC Cancer Review:Animal Limited 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: 24,85,1980
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X6128
No. of Facilities: 145 (estimated)
No. of Industries: 1
No. of Occupations: 4
No. of Employees: 3818 (estimated)
No. of Female Employees: 3142 (estimated)
*** STATUS IN U.S. ***
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998
*** END OF RECORD ***