*** CHEMICAL IDENTIFICATION *** RTECS NUMBER : WG2932500 CHEMICAL NAME : Sorbitan, monooleate polyoxyethylene deriv. CAS REGISTRY NUMBER : 9005-65-6 LAST UPDATED : 199710 DATA ITEMS CITED : 28 COMPOUND DESCRIPTOR : Tumorigen Mutagen Reproductive Effector Primary Irritant SYNONYMS/TRADE NAMES : * Armotan pmo-20 * Atlox 1087 * Atlox 8916TF * Capmul poe-O * Crill 10 * Crill 11 * Crillet 4 * Crill S 10 * Drewmulse poe-smo * Durfax 80 * Emsorb 6900 * Ethoxylated sorbitan monooleate * Glycosperse O-20 * Glycosperse O-20 VEG * Glycosperse O-20X * Hodag SVO 9 * MO 55F * Monitan * Montanox 80 * NCI-C60286 * Nikkol TO * Nikkol TO 10 * Olothorb * Polyethylene oxide sorbitan mono-oleate * Polyoxyethylene sorbitan monooleate * Polyoxyethylene (20) sorbitan mono-oleate * Polyoxyethylene sorbitan oleate * Polysorban 80 * Polysorbate 80 * Polysorbate 81 * Polysorbate 80 B.P.C. * Polysorbate 80, U.S.P. * Protasorb O-20 * Romulgin O * Sorbimacrogol oleate * Sorbimacrogol oleate 300 * Sorbital 0 20 * Sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivatives * Sorbon T 80 * Sorethytan (20) monooleate * Sorlate * SVO 9 * TO 10 * Tween 80 * Tween 81 * Tween 80 A *** 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 : 150 mg REACTION SEVERITY : Mild REFERENCE : AROPAW Archives of Ophthalmology (Chicago). (AMA, 535 N. Dearborn St., Chicago, IL 60610) New series: V.1-44(3), 1929-50; V.64- 1960- Volume(issue)/page/year: 40,668,1948 ** ACUTE TOXICITY DATA ** TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 34500 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 : 6804 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: 35,804,1985 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 1790 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : FAONAU FAO Nutrition Meetings Report Series. (Rome, Italy) No.?-57, 1948-77. Discontinued. Volume(issue)/page/year: 53A,254,1974 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 25 gm/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica, Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year: 101,173,1962 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 7600 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : PHTHDT Pharmacology and Therapeutics. (Pergamon Press Ltd., Headington Hill Hall, Oxford OX3 0BW, UK) V.4- 1979- Volume(issue)/page/year: 5,467,1979 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Rodent - mouse DOSE/DURATION : 4500 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: 18,666,1968 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Mammal - dog DOSE/DURATION : 500 mg/kg TOXIC EFFECTS : Behavioral - altered sleep time (including change in righting reflex) Cardiac - other changes REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 28,1586,1978 TYPE OF TEST : LDLo - Lowest published lethal dose ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Mammal - cat DOSE/DURATION : 500 mg/kg TOXIC EFFECTS : Behavioral - altered sleep time (including change in righting reflex) Cardiac - other changes REFERENCE : ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- Volume(issue)/page/year: 28,1586,1978 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Mammal - species unspecified DOSE/DURATION : 25 gm/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ZYZAEU Zhongguo Yaoxue Zazhi. Chinese Pharmacuetical Journal. (China International Book Trading Corp., POB 2820, Beijing, Peop. China) V.24- 1989- Volume(issue)/page/year: 26,459,1991 TYPE OF TEST : LD50 - Lethal dose, 50 percent kill ROUTE OF EXPOSURE : Intravenous SPECIES OBSERVED : Mammal - species unspecified DOSE/DURATION : 5800 mg/kg TOXIC EFFECTS : Details of toxic effects not reported other than lethal dose value REFERENCE : ZYZAEU Zhongguo Yaoxue Zazhi. Chinese Pharmacuetical Journal. (China International Book Trading Corp., POB 2820, Beijing, Peop. China) V.24- 1989- Volume(issue)/page/year: 26,459,1991 ** OTHER MULTIPLE DOSE TOXICITY DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 42 gm/kg/2W-C TOXIC EFFECTS : Nutritional and Gross Metabolic - weight loss or decreased weight gain REFERENCE : NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-415,1992 ** TUMORIGENIC DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 2163 gm/kg/2Y-C TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Endocrine - adrenal cortex tumors REFERENCE : NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-415,1992 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Subcutaneous SPECIES OBSERVED : Rodent - rat DOSE/DURATION : 10 gm/kg/27W-I TOXIC EFFECTS : Tumorigenic - equivocal tumorigenic agent by RTECS criteria Tumorigenic - tumors at site of application REFERENCE : FCTXAV Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. Volume(issue)/page/year: 9,463,1971 ** REPRODUCTIVE DATA ** TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 635 gm/kg SEX/DURATION : multigenerations TOXIC EFFECTS : Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4 per # born alive) Reproductive - Effects on Newborn - weaning or lactation index (e.g., # alive at weaning per # alive at day 4) REFERENCE : JONUAI Journal of Nutrition. (Subscription Dept., 9650 Rockville Pike, Bethesda, MD 20014) V.1- 1928- Volume(issue)/page/year: 60,489,1956 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Oral SPECIES OBSERVED : Rodent - rat DOSE : 1270 gm/kg SEX/DURATION : female 84 day(s) pre-mating - 21 day(s) post-birth TOXIC EFFECTS : Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4 per # born alive) REFERENCE : JONUAI Journal of Nutrition. (Subscription Dept., 9650 Rockville Pike, Bethesda, MD 20014) V.1- 1928- Volume(issue)/page/year: 60,489,1956 TYPE OF TEST : TDLo - Lowest published toxic dose ROUTE OF EXPOSURE : Intraperitoneal SPECIES OBSERVED : Rodent - rat DOSE : 80 uL/kg SEX/DURATION : lactating female 4 day(s) post-birth TOXIC EFFECTS : Reproductive - Maternal Effects - uterus, cervix, vagina Reproductive - Maternal Effects - menstrual cycle changes or disorders Reproductive - Effects on Newborn - physical REFERENCE : FCTOD7 Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- Volume(issue)/page/year: 31,183,1993 ** MUTATION DATA ** TYPE OF TEST : DNA inhibition TEST SYSTEM : Human Lymphocyte DOSE/DURATION : 20 ppm REFERENCE : BBRCA9 Biochemical and Biophysical Research Communications. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 45,630,1971 TYPE OF TEST : DNA inhibition TEST SYSTEM : Rodent - mouse Cells - not otherwise specified DOSE/DURATION : 20 ppm REFERENCE : ENPBBC Environmental Physiology and Biochemistry. (Copenhagen, Denmark) V.2-5, 1972-75. Discontinued. Volume(issue)/page/year: 5,84,1975 *** REVIEWS *** TOXICOLOGY REVIEW ARTODN Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.32- 1974- Volume(issue)/page/year: 32,245,1974 *** 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 : NOHS - National Occupational Hazard Survey (1974) NOHS Hazard Code - 80605 No. of Facilities: 1388 (estimated) No. of Industries: 18 No. of Occupations: 32 No. of Employees: 24861 (estimated) NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X8582 No. of Facilities: 6365 (estimated) No. of Industries: 38 No. of Occupations: 70 No. of Employees: 162120 (estimated) No. of Female Employees: 112349 (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 NTP Carcinogenesis Studies (feed);equivocal evidence:rat NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-415,92 NTP Carcinogenesis Studies (feed);no evidence:mouse NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-415,92 *** END OF RECORD ***