Rtecs number : ww2710000 chemical name : Talc (powder), containing no asbestos fibers

TWEEN 40

CHEMICAL NAME : Sorbitan, monopalmitate polyoxyethylene deriv.

CAS REGISTRY NUMBER : 9005-66-7

LAST UPDATED : 199701

DATA ITEMS CITED : 7

MOLECULAR FORMULA : C62-H122-O26

MOLECULAR WEIGHT : 1283.84

SYNONYMS/TRADE NAMES :

* Polyoxyethylene sorbitan monopalmitate

* Tween 40

* Polyoxyethylene 20 sorbitan monopalmitate

* Polysorbate 40

* Sorbitan, monohexadecanoate, poly(oxy-1,2-ethanediyl) derivs.

* Radiasurf 7145

*** 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 : >38400 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 : LDLo - Lowest published lethal dose

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : >4 gm/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

JPPMAB Journal of Pharmacy and Pharmacology. (Pharmaceutical Soc. of

Great

Volume(issue)/page/year: 11,150,1959

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Intravenous

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : 1580 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 : Intravenous

SPECIES OBSERVED : Rodent - mouse

DOSE/DURATION : 50 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

*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :

NOHS - National Occupational Hazard Survey (1974)

NOHS Hazard Code - M0758

No. of Facilities: 12 (estimated)

No. of Industries: 1

No. of Occupations: 1

No. of Employees: 147 (estimated)

NOES - National Occupational Exposure Survey (1983)

NOES Hazard Code - X9527

No. of Facilities: 522 (estimated)

No. of Industries: 7

No. of Occupations: 12

No. of Employees: 12166 (estimated)

No. of Female Employees: 8562 (estimated)

*** STATUS IN U.S. ***

EPA TSCA Section 8(b) CHEMICAL INVENTORY

TWEEN 80

CHEMICAL NAME : Sorbitan, monooleate polyoxyethylene deriv.

CAS REGISTRY NUMBER : 9005-65-6

LAST UPDATED : 199904

DATA ITEMS CITED : 28

COMPOUND DESCRIPTOR : Tumorigen

Mutagen

Reproductive Effector

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

* 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:

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

** 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)

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)

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-

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

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 1999

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-415,1992

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-415,1992