*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : YS5000000 CHEMICAL NAME : Urea, 1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitroso- CAS REGISTRY NUMBER : 13909-09-6 LAST UPDATED : 199510 DATA ITEMS CITED : 44 MOLECULAR FORMULA : C10-H18-Cl-N3-O2 MOLECULAR WEIGHT : 247.76 WISWESSER LINE NOTATION : L6TJ AMVNNO&2G D1 COMPOUND DESCRIPTOR : Tumorigen Drug Mutagen Human Primary Irritant SYNONYMS/TRADE NAMES : * 1-(2-Chloroethyl)-3-(4-methyl-cyclohexyl)-1-nitrosourea * 1-(2-Chloroethyl)-3-(trans-4-methyl-cyclohexyl)-1-nitrosourea * N-(2-Chloroethyl)-N'-(trans-4-methylcyclohexyl)-N-nitrosourea * ICIG 1110 * Lomustine, methyl- * ME-Ccnu * Methyl-ccnu * trans-Methyl-ccnu * NCI-C04955 * NSC-95441 * Semustine * Urea, N-(2-chloroethyl)-N'-(4-methylcyclohexyl)-N-nitroso- * Urea, 1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitroso-, trans- *** HEALTH HAZARD DATA *** ** SKIN/EYE IRRITATION DATA ** TYPE OF TEST : Rinsed with water ROUTE OF EXPOSURE : Administration onto the skin SPECIES OBSERVED : Rodent - rabbit DOSE/DURATION : 5 mg/24H REFERENCE : TXCYAC Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- Volume(issue)/page/year: 14,117,1979 ** ACUTE TOXICITY DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human DOSE/DURATION : 90 mg/kg TOXIC EFFECTS : Gastrointestinal - nausea or vomiting Blood - leukopenia Blood - thrombocytopenia REFERENCE : CCYPBY Cancer Chemotherapy Reports, Part 3. (Washington, DC) V.1-6, 1968-75. For publisher information, see CTRRDO. Volume(issue)/page/year: 4,257,1973 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human DOSE/DURATION : 6 mg/kg TOXIC EFFECTS : Gastrointestinal - nausea or vomiting Blood - leukopenia Blood - thrombocytopenia REFERENCE : CTRRDO Cancer Treatment Reports. (Washington, DC) V.60-71, 1976-87. For publisher information, see JNCIEQ. Volume(issue)/page/year: 60,709,1976 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - child DOSE/DURATION : 5550 mg/kg/30W-I TOXIC EFFECTS : Kidney, Ureter, Bladder - changes in both tubules and glomeruli REFERENCE : NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10 Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year: 300,1200,1979 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - child DOSE/DURATION : 37950 mg/kg/2Y-I TOXIC EFFECTS : Kidney, Ureter, Bladder - changes in both tubules and glomeruli REFERENCE : NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10 Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year: 300,1200,1979 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 100 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: 82,540,1986 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 49900 ug/kg TOXIC EFFECTS : Behavioral - changes in motor activity (specific assay) Behavioral - withdrawal REFERENCE : NTIS** National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. Volume(issue)/page/year: PB269-473 TYPE OF TEST : LD10 - Lethal Dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 37 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 34,194,1974 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Unreported SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 30 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : EJMCA5 European Journal of Medicinal Chemistry--Chimie Therapeutique. (Editions Scientifiques Elsevier, 29 rue Buffon, F-75005, Paris, France) V.9- 1974- Volume(issue)/page/year: 12,397,1977 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Mammal - dog DOSE/DURATION : 25 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ACRSAJ Advances in Cancer Research. (Academic Press, Inc., 465 S. Lincoln Dr., Troy, MO 63379) V.1- 1953- Volume(issue)/page/year: 16,273,1972 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Mammal - dog DOSE/DURATION : 14 mg/kg TOXIC EFFECTS : Gastrointestinal - hypermotility, diarrhea Blood - agranulocytosis Nutritional and Gross Metabolic - body temperature decrease REFERENCE : CTRRDO Cancer Treatment Reports. (Washington, DC) V.60-71, 1976-87. For publisher information, see JNCIEQ. Volume(issue)/page/year: 60,1559,1976 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Primate - monkey DOSE/DURATION : 100 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : CCYPBY Cancer Chemotherapy Reports, Part 3. (Washington, DC) V.1-6, 1968-75. For publisher information, see CTRRDO. Volume(issue)/page/year: 4(3),13,1973 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Primate - monkey DOSE/DURATION : 45 mg/kg TOXIC EFFECTS : Gastrointestinal - hypermotility, diarrhea Blood - changes in bone marrow (not otherwise specified) Blood - other changes REFERENCE : CTRRDO Cancer Treatment Reports. (Washington, DC) V.60-71, 1976-87. For publisher information, see JNCIEQ. Volume(issue)/page/year: 60,1559,1976 ** TUMORIGENIC DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human DOSE/DURATION : 22 mg/kg/60W-C TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Blood - leukemia REFERENCE : NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10 Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year: 309,1079,1983 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 30 mg/kg/7W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Lungs, Thorax, or Respiration - tumors Skin and Appendages - tumors REFERENCE : CANCAR Cancer (Philadelphia). (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1948- Volume(issue)/page/year: 40,1935,1977 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 32 mg/kg/60W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Gastrointestinal - tumors REFERENCE : DTESD7 52 Vanderbilt Ave., New York, NY 10017) V.1-15, 1977-87. Discontinued 52 Vanderbilt Ave., New York, NY 10017) V.1- 1977- Volume(issue)/page/year: 8,273,1980 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 117 mg/kg/26W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Blood - leukemia Blood - lymphoma, including Hodgkin's disease REFERENCE : CANCAR Cancer (Philadelphia). (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1948- Volume(issue)/page/year: 40,1935,1977 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 64 mg/kg/60W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Gastrointestinal - tumors REFERENCE : DTESD7 52 Vanderbilt Ave., New York, NY 10017) V.1-15, 1977-87. Discontinued 52 Vanderbilt Ave., New York, NY 10017) V.1- 1977- Volume(issue)/page/year: 8,273,1980 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 127 mg/kg/60W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Brain and Coverings - tumors Gastrointestinal - tumors REFERENCE : DTESD7 52 Vanderbilt Ave., New York, NY 10017) V.1-15, 1977-87. Discontinued 52 Vanderbilt Ave., New York, NY 10017) V.1- 1977- Volume(issue)/page/year: 8,273,1980 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 203 mg/kg/48W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Lungs, Thorax, or Respiration - tumors Gastrointestinal - tumors REFERENCE : DTESD7 52 Vanderbilt Ave., New York, NY 10017) V.1-15, 1977-87. Discontinued 52 Vanderbilt Ave., New York, NY 10017) V.1- 1977- Volume(issue)/page/year: 8,273,1980 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Human - woman DOSE/DURATION : 73 mg/kg/3Y-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Blood - leukemia REFERENCE : NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10 Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year: 302,120,1980 ** MUTATION DATA ** TYPE OF TEST : Mutation in microorganisms TEST SYSTEM : Bacteria - Salmonella typhimurium DOSE/DURATION : 100 nmol/plate 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: 65,149,1980 TYPE OF TEST : DNA adduct TEST SYSTEM : Bacteria - Escherichia coli DOSE/DURATION : 50 umol/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 89,95,1981 TYPE OF TEST : Gene conversion and mitotic recombination TEST SYSTEM : Yeast - Saccharomyces cerevisiae DOSE/DURATION : 238 mg/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 204,239,1988 TYPE OF TEST : DNA inhibition TEST SYSTEM : Human Leukocyte DOSE/DURATION : 1 umol/L REFERENCE : BBACAQ Biochimica et Biophysica Acta. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1947- Volume(issue)/page/year: 425,463,1976 TYPE OF TEST : Mutation test systems - not otherwise specified TEST SYSTEM : Human Lymphocyte DOSE/DURATION : 2 mg/L REFERENCE : TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 44,153,1988 TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Human Lymphocyte DOSE/DURATION : 2 mg/L REFERENCE : TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 44,153,1988 TYPE OF TEST : Sister chromatid exchange TEST SYSTEM : Human Lymphocyte DOSE/DURATION : 1 mg/L REFERENCE : TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 44,153,1988 TYPE OF TEST : Micronucleus test ROUTE OF EXPOSURE : Oral TEST SYSTEM : Rodent - mouse DOSE/DURATION : 4 mg/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 286,101,1993 TYPE OF TEST : Micronucleus test ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 5 mg/kg REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 286,101,1993 TYPE OF TEST : Unscheduled DNA synthesis ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 4 mg/kg REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 35,2420,1975 TYPE OF TEST : DNA inhibition ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 4 mg/kg REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 35,2420,1975 TYPE OF TEST : DNA inhibition TEST SYSTEM : Rodent - mouse Cells - not otherwise specified DOSE/DURATION : 10 umol/L REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 43,5837,1983 TYPE OF TEST : DNA inhibition ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - hamster DOSE/DURATION : 40 mg/kg REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 34,1957,1974 TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Rodent - hamster Ovary DOSE/DURATION : 5 mg/L REFERENCE : NEOLA4 Neoplasma. (Karger-Libri, P.O. Box, CH-4009 Basel, Switzerland) V.4- 1957- Volume(issue)/page/year: 33,33,1986 TYPE OF TEST : Sister chromatid exchange TEST SYSTEM : Rodent - hamster Ovary DOSE/DURATION : 1 mg/L REFERENCE : NEOLA4 Neoplasma. (Karger-Libri, P.O. Box, CH-4009 Basel, Switzerland) V.4- 1957- Volume(issue)/page/year: 33,33,1986 TYPE OF TEST : DNA damage TEST SYSTEM : Mammal - species unspecified Lymphocyte DOSE/DURATION : 2 mmol/L REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 44,1887,1984 *** REVIEWS *** IARC Cancer Review:Animal Limited Evidence IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year: 7,150,1987 IARC Cancer Review:Human Sufficient Evidence IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year: 7,150,1987 IARC Cancer Review:Group 1 IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year: 7,150,1987 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X1943 No. of Facilities: 8 (estimated) No. of Industries: 1 No. of Occupations: 1 No. of Employees: 229 (estimated) No. of Female Employees: 82 (estimated) *** STATUS IN U.S. *** NCI Carcinogenesis Studies (ipr);clear evidence:rat CANCAR Cancer (Philadelphia). (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1948- Volume(issue)/page/year: 40,1935,77 NCI Carcinogenesis Studies (ipr);no evidence:mouse CANCAR Cancer (Philadelphia). (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1948- Volume(issue)/page/year: 40,1935,77 NTP 7th Annual Report on Carcinogens, 1992 : known to be carcinogenic *** END OF RECORD ***