*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : TR7400000 CHEMICAL NAME : Polysorbate 20 CAS REGISTRY NUMBER : 9005-64-5 LAST UPDATED : 199710 DATA ITEMS CITED : 21 MOLECULAR FORMULA : C58-H114-O26 MOLECULAR WEIGHT : 1227.72 COMPOUND DESCRIPTOR : Drug Reproductive Effector Primary Irritant SYNONYMS/TRADE NAMES : * Armotan pml-20 * Capmul * Dxewmulse poe-sml * Emsorb 6915 * Glycosperse L-20 * Glycosperse L-20X * Hodag psml-20 * Liposorb L-20 * Poe 20 sorbitan monolaurate * Polyoxyethylene (20) sorbitan monolaurate * Protasorb L-20 * PSML * Sorbimacrogol laurate 300 * Sorbitan, monododecanote, poly(oxy-1,2-ethanediyl) derivatives * Tween 20 *** HEALTH HAZARD DATA *** ** SKIN/EYE IRRITATION DATA ** TYPE OF TEST : Standard Draize test ROUTE OF EXPOSURE : Administration onto the skin SPECIES OBSERVED : Human DOSE/DURATION : 15 mg/3D (Intermittent) REACTION SEVERITY : Mild REFERENCE : 85DKA8 "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977 Volume(issue)/page/year: -,127,1977 ** ACUTE TOXICITY DATA ** TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 36700 uL/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FOREAE Food Research. (Champaign, IL) V.1-25, 1936-60. For publisher information, see JFDSAZ. Volume(issue)/page/year: 21,348,1956 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 3850 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 26,1581,1976 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 770 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 26,1581,1976 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : >33 gm/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 26,1581,1976 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 2640 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 26,1581,1976 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 1420 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : RPOBAR Research Progress in Organic-Biological and Medicinal Chemistry. (New York, NY) V.1-3, 1964-72. Discontinued. Volume(issue)/page/year: 2,316,1970 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - hamster DOSE/DURATION : 18 mL/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FOREAE Food Research. (Champaign, IL) V.1-25, 1936-60. For publisher information, see JFDSAZ. Volume(issue)/page/year: 21,348,1956 ** OTHER MULTIPLE DOSE TOXICITY DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 832 gm/kg/59D-C TOXIC EFFECTS : Gastrointestinal - hypermotility, diarrhea Related to Chronic Data - death REFERENCE : ABBIA4 Archives of Biochemistry and Biophysics. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.31- 1951- Volume(issue)/page/year: 34,249,1951 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 931 gm/kg/70D-C TOXIC EFFECTS : Gastrointestinal - hypermotility, diarrhea Liver - fatty liver degeneration Liver - other changes REFERENCE : ABBIA4 Archives of Biochemistry and Biophysics. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.31- 1951- Volume(issue)/page/year: 34,249,1951 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 2756 gm/kg/21W-C TOXIC EFFECTS : Gastrointestinal - hypermotility, diarrhea Kidney, Ureter, Bladder - other changes Blood - other changes REFERENCE : FOREAE Food Research. (Champaign, IL) V.1-25, 1936-60. For publisher information, see JFDSAZ. Volume(issue)/page/year: 21,348,1956 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 33250 gm/kg/95W-C TOXIC EFFECTS : Blood - pigmented or nucleated red blood cells Blood - changes in erythrocyte (RBC) count REFERENCE : TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 7,320,1965 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - hamster DOSE/DURATION : 3276 gm/kg/39W-C TOXIC EFFECTS : Gastrointestinal - other changes Liver - other changes Blood - changes in spleen REFERENCE : FOREAE Food Research. (Champaign, IL) V.1-25, 1936-60. For publisher information, see JFDSAZ. Volume(issue)/page/year: 21,348,1956 ** REPRODUCTIVE DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE : 1 gm/kg SEX/DURATION : female 9 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - musculoskeletal system REFERENCE : ZNCBDA Zeitschrift fuer Naturforschung, Section C: Biosciences. (Verlag der Zeitschrift fuer Naturforschung, Postfach 2645, D-7400 Tuebingen, Fed. Rep. Ger.) V.29- 1974- Volume(issue)/page/year: 36,904,1981 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE : 2500 mg/kg SEX/DURATION : female 9 day(s) after conception TOXIC EFFECTS : Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) REFERENCE : ZNCBDA Zeitschrift fuer Naturforschung, Section C: Biosciences. (Verlag der Zeitschrift fuer Naturforschung, Postfach 2645, D-7400 Tuebingen, Fed. Rep. Ger.) V.29- 1974- Volume(issue)/page/year: 36,904,1981 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE : 1 gm/kg SEX/DURATION : female 9 day(s) after conception TOXIC EFFECTS : Reproductive - Specific Developmental Abnormalities - other developmental abnormalities 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: 26(3),19A,1982 *** U.S. STANDARDS AND REGULATIONS *** EPA FIFRA 1988 PESTICIDE SUBJECT TO REGISTRATION OR RE-REGISTRATION FEREAC Federal Register. (U.S. Government Printing Office, Supt. of Documents, Washington, DC 20402) V.1- 1936- Volume(issue)/page/year: 54,7740,1989 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X6874 No. of Facilities: 5475 (estimated) No. of Industries: 22 No. of Occupations: 48 No. of Employees: 161625 (estimated) No. of Female Employees: 125776 (estimated) *** STATUS IN U.S. *** EPA TSCA Section 8(b) CHEMICAL INVENTORY EPA TSCA Section 8(d) unpublished health/safety studies EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998 *** END OF RECORD ***