*** 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 ***