*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : YS4550000 CHEMICAL NAME : Urea, 1-butyl-3-(p-tolylsulfonyl)- CAS REGISTRY NUMBER : 64-77-7 BEILSTEIN REFERENCE NO. : 1984428 REFERENCE : 4-11-00-00396 (Beilstein Handbook Reference) LAST UPDATED : 199806 DATA ITEMS CITED : 40 MOLECULAR FORMULA : C12-H18-N2-O3-S MOLECULAR WEIGHT : 270.38 WISWESSER LINE NOTATION : 4MVMSWR D1 COMPOUND DESCRIPTOR : Tumorigen Drug Mutagen Reproductive Effector Human SYNONYMS/TRADE NAMES : * Aglicid * Arcosal * Arkozal * Artosin * Artozin * Beglucin * Butamid * Butamide * 1-Butyl-3-(p-methylphenylsulfonyl)urea * Benzenesulfonamide, N-((butylamino)carbonyl)-4-methyl- * N-Butyl-N'-p-toluenesulfonylurea * N-Butyl-N'-toluene-p-sulfonylurea * 1-Butyl-3-(p-tolylsulfonyl)urea * N-n-Butyl-N'-tosylurea * 1-Butyl-3-tosylurea * D 860 * Diaben * Diabetamid * Diabetol * Diabuton * Dolipol * Drabet * HLS 831 * Ipoglicone * N-4-Methylbenzolsulfonyl-N-butylurea * Mobenol * NCI-C01763 * Orabet * Oralin * Orezan * Orinase * Orinaz * Oterben * Rastinon * SK-Tolbutamide * N-(Sulfonyl-p-methylbenzene)-N'-n-butylurea * Tolbusal * Tolbutamid * Tolbutamide * Tolbutamidum * 1-p-Toluenesulfonyl-3-butylurea * Toluina * Tolumid * Toluvan * N-(p-Tolylsulfonyl)-N'-butylcarbamide * Tolylsulfonylbutylurea * 3-(p-Tolyl-4-sulfonyl)-1-butylurea * Willbutamide *** HEALTH HAZARD DATA *** ** ACUTE TOXICITY DATA ** TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE/DURATION : 1 gm/kg TOXIC EFFECTS : Gastrointestinal - nausea or vomiting Endocrine - hypoglycemia REFERENCE : ATXKA8 Archiv fuer Toxikologie. (Berlin, Fed. Rep. Ger.) V.15-31, 1954-74. For publisher information, see ARTODN. Volume(issue)/page/year: 23,153,1968 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 2490 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : PMDCAY Progress in Medical Chemistry. (Elsevier Science Pub. Co., Inc., 52 Vanderbilt Ave., New York, NY 10017) V.1- 1961- Volume(issue)/page/year: 1,187,1961 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 860 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FRPSAX Farmaco, Edizione Scientifica. (Casella Postale 227, 27100 Pavia, Italy) V.8-43 1953-88 For publisher information, see FRMCE8 Volume(issue)/page/year: 12,268,1957 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 700 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : PMDCAY Progress in Medical Chemistry. (Elsevier Science Pub. Co., Inc., 52 Vanderbilt Ave., New York, NY 10017) V.1- 1961- Volume(issue)/page/year: 1,187,1961 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 490 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : IJCREE International Journal of Crude Drug Research. (Swets & Zeitlinger B.V., POB 825, 2160 SZ Lisse, Netherlands) V.20- 1982- Volume(issue)/page/year: 26,81,1988 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 650 mg/kg TOXIC EFFECTS : Behavioral - ataxia Endocrine - hypoglycemia Nutritional and Gross Metabolic - body temperature decrease REFERENCE : TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 4,631,1962 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 980 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : NATUAS Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736) V.1- 1869- Volume(issue)/page/year: 193,891,1962 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 770 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : PMDCAY Progress in Medical Chemistry. (Elsevier Science Pub. Co., Inc., 52 Vanderbilt Ave., New York, NY 10017) V.1- 1961- Volume(issue)/page/year: 1,187,1961 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Unreported SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 700 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FRZKAP Farmatsevtichnii Zhurnal (Kiev). (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.3- 1930- Volume(issue)/page/year: (5),26,1983 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Mammal - species unspecified DOSE/DURATION : 750 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FRZKAP Farmatsevtichnii Zhurnal (Kiev). (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.3- 1930- Volume(issue)/page/year: (1),51,1985 ** REPRODUCTIVE DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE : 2 mg/kg SEX/DURATION : female 1-13 week(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - cardiovascular (circulatory) system Reproductive - Effects on Newborn - other neonatal measures or effects REFERENCE : CMAJAX Canadian Medical Association Journal. (Canadian Medical Assoc., POB 8650, Ottawa, ON K1G 0G8, Canada) V.1- 1911- Volume(issue)/page/year: 87,193,1962 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE : 2600 mg/kg SEX/DURATION : female 1-37 week(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - urogenital system Reproductive - Effects on Newborn - other neonatal measures or effects REFERENCE : JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year: 77,457,1970 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Unreported SPECIES OBSERVED : Human - woman DOSE : 1800 mg/kg SEX/DURATION : female 26-39 week(s) after conception TOXIC EFFECTS : Reproductive - Effects on Newborn - stillbirth REFERENCE : BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 2,187,1964 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 3 gm/kg SEX/DURATION : female 10 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetal death REFERENCE : PROEAS Problemy Endokrinologii. Problems of Endocrinology. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-6, 1936-41; 13- 1967- Volume(issue)/page/year: 14,89,1968 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 12 gm/kg SEX/DURATION : female 1-12 day(s) after conception TOXIC EFFECTS : Reproductive - Fertility - abortion Reproductive - Effects on Embryo or Fetus - fetal death REFERENCE : COREAF Comptes Rendus Hebdomadaires des Seances, Academie des Sciences. (Paris, France) V.1-261, 1835-1965. For publisher information, see CRASEV. Volume(issue)/page/year: 247,1134,1958 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 8400 mg/kg SEX/DURATION : male 3 day(s) pre-mating female 3 day(s) pre-mating - 22 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: 7,409,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 70 mg/kg SEX/DURATION : female 7-13 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 - Effects on Newborn - live birth index (measured after birth) REFERENCE : KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960- Volume(issue)/page/year: 6,1969,1972 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE : 1650 mg/kg SEX/DURATION : female 1-22 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Newborn - biochemical and metabolic REFERENCE : METAAJ Metabolism, Clinical and Experimental. (Grune & Stratton, Inc., Journal Subscriptions Dept., POB 6280, Duluth, MN 55806) V.1- 1952- Volume(issue)/page/year: 22,1389,1973 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE : 5400 mg/kg SEX/DURATION : female 9-14 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - eye/ear REFERENCE : SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho, Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher information, see CGANE7. Volume(issue)/page/year: 17,31,1977 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE : 1700 mg/kg SEX/DURATION : female 1-17 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - musculoskeletal system REFERENCE : SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho, Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher information, see CGANE7. Volume(issue)/page/year: 5,96,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE : 1250 mg/kg SEX/DURATION : female 2 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 36,219,1986 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE : 400 mg/kg SEX/DURATION : female 13 day(s) after conception TOXIC EFFECTS : Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) REFERENCE : ANREAK Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08- Volume(issue)/page/year: 178,308,1974 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rabbit DOSE : 1800 mg/kg SEX/DURATION : female 8-16 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 - cardiovascular (circulatory) system Reproductive - Effects on Embryo or Fetus - fetal death REFERENCE : TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 10,244,1967 ** MUTATION DATA ** TYPE OF TEST : Mutation in microorganisms TEST SYSTEM : Bacteria - Escherichia coli DOSE/DURATION : 50 mmol/L REFERENCE : BZARAZ Biologicheskii Zhurnal Armenii. Biological Journal of Armenia. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.19- 1966- Volume(issue)/page/year: 33,960,1980 TYPE OF TEST : Mutation in microorganisms TEST SYSTEM : Microorganism - not otherwise specified DOSE/DURATION : 200 mmol/L REFERENCE : BZARAZ Biologicheskii Zhurnal Armenii. Biological Journal of Armenia. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.19- 1966- Volume(issue)/page/year: 33,960,1980 TYPE OF TEST : Sister chromatid exchange ROUTE OF EXPOSURE : Oral TEST SYSTEM : Rodent - mouse DOSE/DURATION : 28600 ug/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 77,349,1980 TYPE OF TEST : Sister chromatid exchange ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 28600 ug/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 77,349,1980 TYPE OF TEST : Micronucleus test ROUTE OF EXPOSURE : Unreported TEST SYSTEM : Rodent - mouse DOSE/DURATION : 2860 mg/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 77,349,1980 TYPE OF TEST : Micronucleus test ROUTE OF EXPOSURE : Oral TEST SYSTEM : Rodent - mouse DOSE/DURATION : 2 gm/kg/24H REFERENCE : TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 34,153,1986 TYPE OF TEST : Sister chromatid exchange ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - hamster DOSE/DURATION : 28600 ug/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 77,349,1980 TYPE OF TEST : Sister chromatid exchange ROUTE OF EXPOSURE : Oral TEST SYSTEM : Rodent - hamster DOSE/DURATION : 28600 ug/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 77,349,1980 *** REVIEWS *** TOXICOLOGY REVIEW KDYIA5 Kidney International. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus Secaucus, NJ 07094) V.1- 1972- Volume(issue)/page/year: 10,82,1976 TOXICOLOGY REVIEW INTEAG Internist. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.1- 1960- Volume(issue)/page/year: 15,7,1974 TOXICOLOGY REVIEW ARVPAX Annual Review of Pharmacology. (Palo Alto, CA) V.1-15, 1961-75. For publisher information, see ARPTDI. Volume(issue)/page/year: 5,447,1965 TOXICOLOGY REVIEW ADVPA3 Advances in Pharmacology. (New York, NY) V.1-6, 1962-68. For publisher information, see AVPCAQ. Volume(issue)/page/year: 4,263,1966 TOXICOLOGY REVIEW LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823- Volume(issue)/page/year: 2,1424,1960 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X4772 No. of Facilities: 66 (estimated) No. of Industries: 1 No. of Occupations: 1 No. of Employees: 857 (estimated) No. of Female Employees: 600 (estimated) *** STATUS IN U.S. *** EPA GENETOX PROGRAM 1988, Positive: Mammalian micronucleus EPA TSCA Section 8(b) CHEMICAL INVENTORY NCI Carcinogenesis Bioassay (feed);no 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-31,77 *** END OF RECORD ***