*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : KN6800000 CHEMICAL NAME : Ether, 2-chloro-1,1,2-trifluoroethyl difluoromethyl CAS REGISTRY NUMBER : 13838-16-9 BEILSTEIN REFERENCE NO. : 1903921 LAST UPDATED : 199712 DATA ITEMS CITED : 39 MOLECULAR FORMULA : C3-H2-Cl-F5-O MOLECULAR WEIGHT : 184.50 WISWESSER LINE NOTATION : GYFXFFOYFF COMPOUND DESCRIPTOR : Tumorigen Drug Mutagen Reproductive Effector Human Primary Irritant SYNONYMS/TRADE NAMES : * Anesthetic Compound No. 347 * 2-Chloro-1-(difluoromethoxy)-1,1,2-trifluoroethane * 2-Chloro-1,1,2-trifluoroethyl difluoromethyl ether * Compound 347 * Enflurane * Ethane, 2-chloro-1-(difluoromethoxy)-1,1,2-trifluoro- * Ethrane * Methylflurether * NSC-115944 * OHIO 347 *** HEALTH HAZARD DATA *** ** SKIN/EYE IRRITATION DATA ** TYPE OF TEST : Standard Draize test ROUTE OF EXPOSURE : Administration into the eye SPECIES OBSERVED : Rodent - rabbit DOSE/DURATION : 100 mg REACTION SEVERITY : Moderate REFERENCE : FEPRA7 Federation Proceedings, Federation of American Societies for Experimental Biology. (Bethesda, MD) V.1-46, 1942-87. Volume(issue)/page/year: 35,729,1976 ** ACUTE TOXICITY DATA ** TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Human DOSE/DURATION : 1 pph/6H TOXIC EFFECTS : Kidney, Ureter, Bladder - urine volume decreased REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 45,557,1976 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 5450 uL/kg TOXIC EFFECTS : Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - other changes REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 TYPE OF TEST : LC50 - Lethal concentration, 50 percent kill ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 14000 ppm/3H TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 12,668,1981 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 6 mL/kg TOXIC EFFECTS : Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - other changes REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 19500 uL/kg TOXIC EFFECTS : Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - other changes REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 5 mL/kg TOXIC EFFECTS : Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - other changes REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 TYPE OF TEST : LC50 - Lethal concentration, 50 percent kill ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 8100 ppm/3H TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 12,668,1981 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 3900 uL/kg TOXIC EFFECTS : Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - other changes REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 38800 uL/kg TOXIC EFFECTS : Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - other changes REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 ** OTHER MULTIPLE DOSE TOXICITY DATA ** TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 170 ppm/3H/4W-I TOXIC EFFECTS : Liver - other changes Liver - changes in liver weight REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,491,1981 ** TUMORIGENIC DATA ** TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 3000 ppm/4H/78W-I TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Lungs, Thorax, or Respiration - tumors Liver - tumors REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 56,9,1982 ** REPRODUCTIVE DATA ** TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - rat DOSE : 16500 ppm/6H SEX/DURATION : female 8-10 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 64,339,1986 TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - rat DOSE : 20 ppm/8H SEX/DURATION : female 28 day(s) pre-mating female 1-21 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) REFERENCE : BJANAD British Journal of Anesthesia. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1923- Volume(issue)/page/year: 53,203,1981 TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - rat DOSE : 1500 ppm/6H SEX/DURATION : female 1-20 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Newborn - other postnatal measures or effects REFERENCE : AIPTAK Archives Internationales de Pharmacodynamie et de Therapie. (Heymans Institute of Pharmacology, De Pintelaan 185, B-9000 Ghent, Belgium) V.4- 1898- Volume(issue)/page/year: 256,134,1982 TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - rat DOSE : 16500 ppm/6H SEX/DURATION : female 11-13 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - musculoskeletal system REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 64,339,1986 TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - mouse DOSE : 1 pph/4H SEX/DURATION : female 6-15 day(s) after conception TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) 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: 19,53A,1979 TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - mouse DOSE : 10000 ppm/4H SEX/DURATION : female 6-15 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - Central Nervous System Reproductive - Specific Developmental Abnormalities - craniofacial (including nose and tongue) Reproductive - Specific Developmental Abnormalities - musculoskeletal system REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 54,505,1981 TYPE OF TEST : TCLo - Lowest published toxic concentration ROUTE OF EXPOSURE : Inhalation SPECIES OBSERVED : Rodent - mouse DOSE : 10000 ppm/4H SEX/DURATION : female 6-15 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - urogenital system REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 54,505,1981 ** MUTATION DATA ** TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Human Lymphocyte DOSE/DURATION : 1000 ppm REFERENCE : ENVRAL Environmental Research. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1967- Volume(issue)/page/year: 12,366,1976 TYPE OF TEST : Mutation test systems - not otherwise specified ROUTE OF EXPOSURE : Inhalation TEST SYSTEM : Rodent - rat DOSE/DURATION : 1 pph/3H (Continuous) REFERENCE : EXPEAM Experientia. (Birkhaeuser Verlag, POB 133, CH-4010 Basel, Switzerland) V.1- 1945- Volume(issue)/page/year: 35,71,1979 TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Rodent - mouse Fibroblast DOSE/DURATION : 1000 ppm REFERENCE : ENVRAL Environmental Research. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1967- Volume(issue)/page/year: 12,366,1976 TYPE OF TEST : Sperm Morphology ROUTE OF EXPOSURE : Inhalation TEST SYSTEM : Rodent - mouse DOSE/DURATION : 12000 ppm/4H/5D (Intermittent) REFERENCE : ANESAV Anesthesiology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1940- Volume(issue)/page/year: 54,53,1981 TYPE OF TEST : Cytogenetic analysis ROUTE OF EXPOSURE : Parenteral TEST SYSTEM : Bird - chicken DOSE/DURATION : 10 mg REFERENCE : ENVRAL Environmental Research. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1967- Volume(issue)/page/year: 12,366,1976 *** REVIEWS *** ACGIH TLV-Not classifiable as a human carcinogen DTLVS* The Threshold Limit Values (TLVs) and Biological Exposure Indices (BEIs) booklet issues by American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, OH, 1996 Volume(issue)/page/year: TLV/BEI,1997 ACGIH TLV-TWA 566 mg/m3 (75 ppm) DTLVS* The Threshold Limit Values (TLVs) and Biological Exposure Indices (BEIs) booklet issues by American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, OH, 1996 Volume(issue)/page/year: TLV/BEI,1997 IARC Cancer Review:Animal Inadequate Evidence IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year: 7,93,1987 *** OCCUPATIONAL EXPOSURE LIMITS *** OEL-AUSTRALIA:TWA 0.5 ppm (3.8 mg/m3) JAN 1993 OEL-BELGIUM:TWA 75 ppm (566 mg/m3) JAN 1993 OEL-DENMARK:TWA 2 ppm (15 mg/m3) JAN 1993 OEL-SWEDEN:TWA 10 ppm (80 mg/m3);STEL 20 ppm (150 mg/m3) JAN 1993 OEL IN BULGARIA, COLOMBIA, JORDAN, KOREA check ACGIH TLV OEL IN NEW ZEALAND, SINGAPORE, VIETNAM check ACGIH TLV *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH RECOMMENDED EXPOSURE LEVEL (REL) : NIOSH REL TO ENFLURANE-air:CL 2 ppm/60M REFERENCE : NIOSH* National Institute for Occupational Safety and Health, U.S. Dept. of Health, Education, and Welfare, Reports and Memoranda. Volume(issue)/page/year: DHHS #92-100,1992 NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X3127 No. of Facilities: 2871 (estimated) No. of Industries: 2 No. of Occupations: 12 No. of Employees: 86214 (estimated) No. of Female Employees: 73439 (estimated) NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X9341 No. of Facilities: 21 (estimated) No. of Industries: 1 No. of Occupations: 1 No. of Employees: 453 (estimated) No. of Female Employees: 329 (estimated) *** STATUS IN U.S. *** EPA GENETOX PROGRAM 1988, Negative: V79 cell culture-gene mutation EPA GENETOX PROGRAM 1988, Inconclusive: Histidine reversion-Ames test; Sperm morphology-mouse OSHA ANALYTICAL METHOD #29 *** END OF RECORD ***