*** 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 ***