*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : US7875000
CHEMICAL NAME           : Pyridine, 2,6-diamino-3-(phenylazo)-,
                          monohydrochloride
CAS REGISTRY NUMBER     : 136-40-3
LAST UPDATED            : 199710
DATA ITEMS CITED        : 29
MOLECULAR FORMULA       : C11-H11-N5.Cl-H
MOLECULAR WEIGHT        : 249.73
WISWESSER LINE NOTATION : T6NJ BZ CNUNR& FZ &GH
COMPOUND DESCRIPTOR     : Tumorigen
                          Drug
                          Mutagen
                          Human
SYNONYMS/TRADE NAMES :
   * Azodyne
   * Bisteril
   * 2,6-Diamino-3-phenylazopyridine hydrochloride
   * 2,6-Diamino-3-(phenylazo)pyridine monohydrochloride
   * Diridone
   * Dolonil
   * Eucistin
   * Giracid
   * Mallofeen
   * Mallophene
   * NC 150
   * NCI-C01672
   * Nefrecil
   * Phenazodine
   * Phenazopyridine hydrochloride
   * Phenazopyridinium chloride
   * Phenylazodiaminopyridine hydrochloride
   * beta-Phenylazo-alpha,alpha'-diaminopyridine hydrochloride
   * 3-Phenylazo-2,6-diaminopyridine hydrochloride
   * Phenylazo-alpha,alpha'-diaminopyridine monohydrochloride
   * Phenylazopyridine hydrochloride
   * 3-(Phenylazo)-2,6-pyridinediamine, hydrochloride
   * Phenylazo tablets
   * Phenyl-idium
   * Phenyl-idium 200
   * Pirid
   * 2,6-Pyridinediamine, 3-(phenylazo)-, monohydrochloride
   * Pyridium
   * Pyridivite
   * Pyripyridium
   * Pyrizin
   * Sedural
   * Thiosulfil-A forte
   * Urazium
   * Uridinal
   * Uriplex
   * Urobiotic-250
   * Urodine
   * W 1655
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 114 mg/kg
TOXIC EFFECTS :
   Gastrointestinal - hypermotility, diarrhea
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Kidney, Ureter, Bladder - urine volume decreased
REFERENCE :
   HUTODJ Human Toxicology.  (Macmillan Press Ltd., Houndmills, Basingstoke,
   Hants., RG 21 2XS, UK) V.1-    1981-  Volume(issue)/page/year: 2,539,1983
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 86 mg/kg/10D-I
TOXIC EFFECTS :
   Spinal Cord - inflammatory changes
REFERENCE :
   AIMEAS Annals of Internal Medicine.  (American College of Physicians, 4200
   Pine St., Philadelphia, PA 19104)  V.1-    1927-  Volume(issue)/page/year:
   106,164,1987
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - child
DOSE/DURATION           : 35 mg/kg
TOXIC EFFECTS :
   Vascular - BP elevation not characterized in autonomic section
   Kidney, Ureter, Bladder - hematuria
   Blood - methemoglobinemia-carboxyhemoglobin
REFERENCE :
   AJDCAI American Journal of Diseases of Children.  (AMA, 535 N. Dearborn St.,
   Chicago, IL 60610) V.1-80(3), 1911-50; V.100-    1960-
   Volume(issue)/page/year: 117,369,1969
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - child
DOSE/DURATION           : 400 mg/kg
TOXIC EFFECTS :
   Behavioral - somnolence (general depressed activity)
   Lungs, Thorax, or Respiration - cyanosis
REFERENCE :
   AJDCAI American Journal of Diseases of Children.  (AMA, 535 N. Dearborn St.,
   Chicago, IL 60610) V.1-80(3), 1911-50; V.100-    1960-
   Volume(issue)/page/year: 110,105,1965
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 34 mg/kg
TOXIC EFFECTS :
   Gastrointestinal - hypermotility, diarrhea
   Kidney, Ureter, Bladder - urine volume decreased
   Nutritional and Gross Metabolic - changes in sodium
REFERENCE :
   AIMEAS Annals of Internal Medicine.  (American College of Physicians, 4200
   Pine St., Philadelphia, PA 19104)  V.1-    1927-  Volume(issue)/page/year:
   72,89,1970
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - child
DOSE/DURATION           : 125 mg/kg
TOXIC EFFECTS :
   Lungs, Thorax, or Respiration - cyanosis
   Blood - other hemolysis with or without anemia
   Blood - methemoglobinemia-carboxyhemoglobin
REFERENCE :
   CPEDAM Clinical Pediatrics (Philadelphia).  (Lippincott/Harper, Journal
   Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740)  V.1-    1962-
   Volume(issue)/page/year: 10,537,1971
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 140 mg/kg
TOXIC EFFECTS :
   Gastrointestinal - nausea or vomiting
   Blood - normocytic anemia
   Nutritional and Gross Metabolic - dehydration
REFERENCE :
   CMAJAX Canadian Medical Association Journal.  (Canadian Medical Assoc., POB
   8650, Ottawa, ON K1G 0G8, Canada)  V.1-    1911-  Volume(issue)/page/year:
   91,756,1964
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 472 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   TXAPA9 Toxicology and Applied Pharmacology.  (Academic Press, Inc., 1 E.
   First St., Duluth, MN 55802) V.1-    1959-  Volume(issue)/page/year:
   1,42,1959
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 200 mg/kg
TOXIC EFFECTS :
   Behavioral - somnolence (general depressed activity)
   Lungs, Thorax, or Respiration - structural or functional change in trachea
   or bronchi
   Lungs, Thorax, or Respiration - dyspnea
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: 51,200,1934
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 180 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   CSLNX* U.S. Army Armament Research & Development Command, Chemical Systems
   Laboratory, NIOSH Exchange Chemicals.  (Aberdeen Proving Ground, MD 21010)
   Volume(issue)/page/year: NX#04014
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 1 gm/kg/24D-I
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - flaccid paralysis with appropriate
   anesthesia
   Liver - fatty liver degeneration
   Related to Chronic Data - death
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: 51,200,1934
 
                          ** TUMORIGENIC DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 225 gm/kg/78W-C
TOXIC EFFECTS :
   Tumorigenic - Carcinogenic by RTECS criteria
   Gastrointestinal - colon tumors
REFERENCE :
   NCITR* National Cancer Institute Carcinogenesis Technical Report Series.
   (Bethesda, MD)  No.0-205. For publisher information, see NTPTR*.
   Volume(issue)/page/year: NCI-TR-99,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 81 gm/kg/80W-C
TOXIC EFFECTS :
   Tumorigenic - Carcinogenic by RTECS criteria
   Liver - tumors
REFERENCE :
   NCITR* National Cancer Institute Carcinogenesis Technical Report Series.
   (Bethesda, MD)  No.0-205. For publisher information, see NTPTR*.
   Volume(issue)/page/year: NCI-TR-99,1978
 
TYPE OF TEST            : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 110 gm/kg/78W-C
TOXIC EFFECTS :
   Tumorigenic - equivocal tumorigenic agent by RTECS criteria
   Gastrointestinal - colon tumors
REFERENCE :
   NCITR* National Cancer Institute Carcinogenesis Technical Report Series.
   (Bethesda, MD)  No.0-205. For publisher information, see NTPTR*.
   Volume(issue)/page/year: NCI-TR-99,1978
 
TYPE OF TEST            : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 40 gm/kg/78W-C
TOXIC EFFECTS :
   Tumorigenic - equivocal tumorigenic agent by RTECS criteria
   Liver - tumors
REFERENCE :
   NCITR* National Cancer Institute Carcinogenesis Technical Report Series.
   (Bethesda, MD)  No.0-205. For publisher information, see NTPTR*.
   Volume(issue)/page/year: NCI-TR-99,1978
 
                            ** MUTATION DATA **
 
TYPE OF TEST            : Unscheduled DNA synthesis
TEST SYSTEM             : Rodent - rat Liver
DOSE/DURATION           : 60 umol/L
REFERENCE :
   MUREAV Mutation Research.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1964-  Volume(issue)/page/year: 315,147,1994
 
TYPE OF TEST            : Micronucleus test
ROUTE OF EXPOSURE       : Intraperitoneal
TEST SYSTEM             : Rodent - mouse
DOSE/DURATION           : 155 mg/kg/48H (Intermittent)
REFERENCE :
   MUREAV Mutation Research.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1964-  Volume(issue)/page/year: 389,3,1997
 
TYPE OF TEST            : Specific locus test
TEST SYSTEM             : Rodent - mouse Lymphocyte
DOSE/DURATION           : 20 mg/L
REFERENCE :
   EMMUEG Environmental and Molecular Mutagenesis.  (Alan R. Liss, Inc., 41 E.
   11th St., New York, NY 10003)  V.10-    1987-  Volume(issue)/page/year:
   17,196,1991
 
TYPE OF TEST            : Cytogenetic analysis
TEST SYSTEM             : Rodent - hamster Ovary
DOSE/DURATION           : 30 mg/L
REFERENCE :
   EMMUEG Environmental and Molecular Mutagenesis.  (Alan R. Liss, Inc., 41 E.
   11th St., New York, NY 10003)  V.10-    1987-  Volume(issue)/page/year:
   10(Suppl 10),1,1987
 
TYPE OF TEST            : Sister chromatid exchange
TEST SYSTEM             : Rodent - hamster Ovary
DOSE/DURATION           : 10 mg/L
REFERENCE :
   EMMUEG Environmental and Molecular Mutagenesis.  (Alan R. Liss, Inc., 41 E.
   11th St., New York, NY 10003)  V.10-    1987-  Volume(issue)/page/year:
   10(Suppl 10),1,1987

                              *** REVIEWS ***
 
   IARC Cancer Review:Animal Sufficient 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: 24,163,1980

   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: 24,163,1980

   IARC Cancer Review:Group 2B
   IMSUDL IARC Monographs, Supplement.  (WHO Publications Centre USA, 49
   Sheridan Ave., Albany, NY 12210)  No.1-    1979-  Volume(issue)/page/year:
   7,312,1987

         *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOHS - National Occupational Hazard Survey (1974)
     NOHS Hazard Code - 83539
       No. of Facilities: 68 (estimated)
       No. of Industries: 1
       No. of Occupations: 6
       No. of Employees: 2770 (estimated)
   
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - 83539
       No. of Facilities: 94 (estimated)
       No. of Industries: 1
       No. of Occupations: 2
       No. of Employees: 2546 (estimated)
       No. of Female Employees: 1328 (estimated)

                          *** STATUS IN U.S. ***
 
   EPA GENETOX PROGRAM 1988, Positive: Carcinogenicity-mouse/rat
   
   EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998
   
   NCI Carcinogenesis Bioassay (feed);clear evidence:mouse,rat
   NCITR* National Cancer Institute Carcinogenesis Technical Report Series.
   (Bethesda, MD)  No.0-205. For publisher information, see NTPTR*.
   Volume(issue)/page/year: NCI-TR-99,78

   NTP 7th Annual Report on Carcinogens, 1992 : anticipated to be carcinogen

 
                            *** END OF RECORD ***