*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : DE4550000 CHEMICAL NAME : 1,2-Benzisothiazolin-3-one, 1,1-dioxide, sodium salt CAS REGISTRY NUMBER : 128-44-9 LAST UPDATED : 199806 DATA ITEMS CITED : 57 MOLECULAR FORMULA : C7-H4-N-O3-S.Na MOLECULAR WEIGHT : 205.17 WISWESSER LINE NOTATION : T56 BSWMVJ &-NA- COMPOUND DESCRIPTOR : Tumorigen Drug Mutagen Reproductive Effector SYNONYMS/TRADE NAMES : * Artificial sweetening substanz gendorf 450 * Cristallose * Crystallose * Dagutan * Kristallose * Madhurin * ODA * Saccharinnatrium * Saccharin, sodium * Saccharin, sodium salt * Saccharin soluble * Saccharoidum natricum * Saxin * Sodium 1,2 benzisothiazolin-3-one-1,1-dioxide * Sodium o-benzosulfimide * Sodium benzosulphimide * Sodium o-benzosulphimide * Sodium 2-benzosulphimide * Sodium saccharide * Sodium saccharin * Sodium saccharinate * Sodium saccharine * Soluble gluside * Soluble saccharin * Sucra * o-Sulfonbenzoic acid imide sodium salt * Sulphobenzoic imide, sodium salt * Sweeta * Sykose * Willosetten *** HEALTH HAZARD DATA *** ** ACUTE TOXICITY DATA ** TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 14200 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FCTXAV Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. Volume(issue)/page/year: 6,313,1968 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 7100 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FCTXAV Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. Volume(issue)/page/year: 6,313,1968 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 17500 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FCTXAV Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. Volume(issue)/page/year: 6,313,1968 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 6 gm/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : USXXAM United States Patent Document. (U.S. Patent Office, Box 9, Washington, DC 20231) Volume(issue)/page/year: #4869913 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 7 gm/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,1367,1981 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rabbit DOSE/DURATION : 4 gm/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 32,1367,1981 ** OTHER MULTIPLE DOSE TOXICITY DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 756 gm/kg/36W-C TOXIC EFFECTS : Kidney, Ureter, Bladder - other changes in urine composition Kidney, Ureter, Bladder - other changes Nutritional and Gross Metabolic - weight loss or decreased weight gain REFERENCE : JTSCDR Journal of Toxicological Sciences. (Japanese Soc. of Toxicological Sciences, 4th Floor, Gakkai Center Bldg., 4-16, Yayoi 2-chome, Bunkyo-ku, Tokyo 113, Japan) V.1- 1976- Volume(issue)/page/year: 6,246,1981 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 32400 mg/kg/54D-C TOXIC EFFECTS : Immunological Including Allergic - decrease in humoral immune response REFERENCE : TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 8,1,1981 ** TUMORIGENIC DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1092 gm/kg/1Y-C TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Kidney, Ureter, Bladder - tumors REFERENCE : GANNA2 Gann. Japanese Journal of Cancer Research. (Tokyo, Japan) V.1-75, 1907-84. For publisher information, see JJCREP. Volume(issue)/page/year: 74,8,1983 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Implant SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 176 mg/kg TOXIC EFFECTS : Tumorigenic - neoplastic by RTECS criteria Kidney, Ureter, Bladder - tumors Tumorigenic - tumors at site of application REFERENCE : SCIEAS Science. (American Assoc. for the Advancement of Science, 1333 H St., NW, Washington, DC 20005) V.1- 1895- Volume(issue)/page/year: 168,1238,1970 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 112 gm/kg/8W-C TOXIC EFFECTS : Tumorigenic - neoplastic by RTECS criteria Kidney, Ureter, Bladder - Kidney tumors Skin and Appendages - tumors REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 37,2943,1977 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 224 gm/kg/8W-C TOXIC EFFECTS : Tumorigenic - neoplastic by RTECS criteria Kidney, Ureter, Bladder - Kidney tumors Skin and Appendages - tumors REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 37,2943,1977 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1330 gm/kg/95W-C TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Kidney, Ureter, Bladder - tumors REFERENCE : CBINA8 Chemico-Biological Interactions. (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 1969- Volume(issue)/page/year: 11,225,1975 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 2660 gm/kg/95W-C TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Kidney, Ureter, Bladder - tumors Kidney, Ureter, Bladder - changes in blood vessels or in circulation of kidney REFERENCE : BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year: 39,355,1979 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1428 gm/kg/2Y-C TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Kidney, Ureter, Bladder - tumors Kidney, Ureter, Bladder - changes in blood vessels or in circulation of kidney REFERENCE : BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year: 39,355,1979 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1190 gm/kg/85W-C TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Kidney, Ureter, Bladder - Kidney tumors Kidney, Ureter, Bladder - changes in blood vessels or in circulation of kidney REFERENCE : BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year: 39,355,1979 TYPE OF TEST : TD - Toxic dose (other than lowest) ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1827 gm/kg/87W-C TOXIC EFFECTS : Tumorigenic - Carcinogenic by RTECS criteria Kidney, Ureter, Bladder - tumors REFERENCE : TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 52,113,1980 ** REPRODUCTIVE DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 15 gm/kg SEX/DURATION : lactating female 15-21 day(s) post-birth TOXIC EFFECTS : Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain) REFERENCE : FCTOD7 Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- Volume(issue)/page/year: 26,899,1988 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 325 gm/kg SEX/DURATION : male 4 week(s) pre-mating female 4 week(s) pre-mating - 4 day(s) post-birth TOXIC EFFECTS : Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain) REFERENCE : FCTOD7 Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- Volume(issue)/page/year: 29,657,1991 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE : 103 gm/kg SEX/DURATION : male 30 day(s) pre-mating TOXIC EFFECTS : Reproductive - Effects on Embryo or Fetus - fetal death REFERENCE : IJMRAQ Indian Journal of Medical Research. (Indian Council of Medical Research, Ansari Nagar, New Delhi 110 029, India) V.1- 1913- Volume(issue)/page/year: 60,599,1972 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE : 2 gm/kg SEX/DURATION : multigenerations TOXIC EFFECTS : Reproductive - Fertility - male fertility index (e.g. # males impregnating females per # males exposed to fertile nonpregnant females) REFERENCE : TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 19,267,1983 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE : 2 gm/kg SEX/DURATION : male 1 day(s) pre-mating TOXIC EFFECTS : Reproductive - Fertility - male fertility index (e.g. # males impregnating females per # males exposed to fertile nonpregnant females) REFERENCE : JEPTDQ Journal of Environmental Pathology and Toxicology. (Park Forest South, IL) V.1-5(3), 1977-81(?). For publisher information, see JEPOEC. Volume(issue)/page/year: 2(4),1047,1979 ** MUTATION DATA ** TYPE OF TEST : Mutation in microorganisms TEST SYSTEM : Bacteria - Salmonella typhimurium DOSE/DURATION : 62 mmol/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 32,81,1975 TYPE OF TEST : Sex chromosome loss and nondisjunction ROUTE OF EXPOSURE : Parenteral TEST SYSTEM : Insect - Drosophila melanogaster DOSE/DURATION : 5 mmol/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 32,81,1975 TYPE OF TEST : Sex chromosome loss and nondisjunction ROUTE OF EXPOSURE : Oral TEST SYSTEM : Insect - Drosophila melanogaster DOSE/DURATION : 5 pph REFERENCE : SBJODP Science of Biology Journal. (Springfield, IL) V.1-4, 1975-78(?). Discontinued. Volume(issue)/page/year: 1,77,1975 TYPE OF TEST : Mutation in microorganisms TEST SYSTEM : Yeast - Saccharomyces cerevisiae DOSE/DURATION : 2 gm/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 67,215,1979 TYPE OF TEST : Gene conversion and mitotic recombination TEST SYSTEM : Yeast - Saccharomyces cerevisiae DOSE/DURATION : 2 gm/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 67,215,1979 TYPE OF TEST : DNA inhibition TEST SYSTEM : Human Fibroblast DOSE/DURATION : 100 mmol/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 183,89,1987 TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Human Leukocyte DOSE/DURATION : 500 mg/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 32,81,1975 TYPE OF TEST : Sister chromatid exchange TEST SYSTEM : Human Leukocyte DOSE/DURATION : 20 umol/L REFERENCE : ENMUDM Environmental Mutagenesis. (New York, NY) V.1-9, 1979-87. For publisher information, see EMMUEG. Volume(issue)/page/year: 1,177,1979 TYPE OF TEST : Mutation in mammalian somatic cells TEST SYSTEM : Human Embryo DOSE/DURATION : 10 gm/L REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 209,13,1988 TYPE OF TEST : Unscheduled DNA synthesis ROUTE OF EXPOSURE : Oral TEST SYSTEM : Rodent - rat DOSE/DURATION : 441 gm/kg/21W (Continuous) REFERENCE : CALEDQ Cancer Letters (Shannon, Ireland). (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 1975- Volume(issue)/page/year: 33,119,1986 TYPE OF TEST : Unscheduled DNA synthesis TEST SYSTEM : Rodent - rat Liver DOSE/DURATION : 1 mg/L REFERENCE : CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year: 40,4541,1980 TYPE OF TEST : Mutation in microorganisms TEST SYSTEM : Rodent - mouse Lymphocyte DOSE/DURATION : 11 gm/L/4H REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 59,61,1979 TYPE OF TEST : DNA damage ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 50 mg/kg REFERENCE : BSIBAC Bolletino della Societe Italiana di Biologia Sperimentale. (Casa Editrice Idelson, Via A. de Gasperi, 55, 80133 Naples, Italy) V.2- 1927- Volume(issue)/page/year: 56,2486,1980 TYPE OF TEST : Cytogenetic analysis ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 1 gm/kg/60H (Intermittent) REFERENCE : BECTA6 Bulletin of Environmental Contamination and Toxicology. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.1- 1966- Volume(issue)/page/year: 12,186,1974 TYPE OF TEST : Dominant lethal test ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 500 mg/kg/60H (Intermittent) REFERENCE : BECTA6 Bulletin of Environmental Contamination and Toxicology. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.1- 1966- Volume(issue)/page/year: 12,186,1974 TYPE OF TEST : Dominant lethal test ROUTE OF EXPOSURE : Oral TEST SYSTEM : Rodent - mouse DOSE/DURATION : 6 gm/kg/30D REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 32,81,1975 TYPE OF TEST : Sperm Morphology ROUTE OF EXPOSURE : Intraperitoneal TEST SYSTEM : Rodent - mouse DOSE/DURATION : 1 gm/kg/60H REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 32,81,1975 TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Rodent - hamster Fibroblast DOSE/DURATION : 8 gm/L/48H REFERENCE : MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 48,337,1977 TYPE OF TEST : Cytogenetic analysis TEST SYSTEM : Rodent - hamster Lung DOSE/DURATION : 1 gm/L REFERENCE : HEREAY Hereditas (Lund, Sweden). (Gjoerloffsgatan 121, S-261 34 Landskrona, Sweden) V.1- 1947- Volume(issue)/page/year: 70,271,1972 *** 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: 22,111,1980 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: 7,334,1987 TOXICOLOGY REVIEW AEHLAU Archives of Environmental Health. (Heldref Pub., 4000 Albemarle St., NW, Washington, DC 20016) V.1- 1960- Volume(issue)/page/year: 23,6,1971 TOXICOLOGY REVIEW EVHPAZ EHP, Environmental Health Perspectives. (U.S. Government Printing Office, Supt of Documents, Washington, DC 20402) No.1- 1972- Volume(issue)/page/year: 25,173,1978 TOXICOLOGY REVIEW BLFSBY Basic Life Sciences. (Plenum Pub. Corp., 223 Spring St., New York, NY 10003) V.1- 1973- Volume(issue)/page/year: 24,253,1983 TOXICOLOGY REVIEW FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year: 13,747,1989 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOHS - National Occupational Hazard Survey (1974) NOHS Hazard Code - 80527 No. of Facilities: 2086 (estimated) No. of Industries: 17 No. of Occupations: 22 No. of Employees: 13433 (estimated) NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X8578 No. of Facilities: 11 (estimated) No. of Industries: 1 No. of Occupations: 5 No. of Employees: 1150 (estimated) No. of Female Employees: 591 (estimated) NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - 80527 No. of Facilities: 1735 (estimated) No. of Industries: 18 No. of Occupations: 44 No. of Employees: 67252 (estimated) No. of Female Employees: 49525 (estimated) *** STATUS IN U.S. *** EPA GENETOX PROGRAM 1988, Positive: Rodent dominant lethal; D melanogaster Sex-linked lethal EPA GENETOX PROGRAM 1988, Positive/dose response: In vitro SCE-human lymphocytes EPA GENETOX PROGRAM 1988, Positive/dose response: In vitro SCE-human; In vitro SCE-nonhuman EPA GENETOX PROGRAM 1988, Negative: Histidine reversion-Ames test; Sperm morphology-mouse EPA GENETOX PROGRAM 1988, Inconclusive: D melanogaster-reciprocal translocation EPA TSCA Section 8(b) CHEMICAL INVENTORY NTP 7th Annual Report on Carcinogens, 1992 : anticipated to be carcinogen *** END OF RECORD ***