*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : TR1579600
CHEMICAL NAME : Poly(1-(2-oxo-1-pyrrolidinyl)ethylene)iodine complex
CAS REGISTRY NUMBER : 25655-41-8
OTHER CAS REGISTRY NOS. : 9006-37-5
LAST UPDATED : 199701
DATA ITEMS CITED : 22
MOLECULAR FORMULA : (C6-H9-N-O)n.xI
COMPOUND DESCRIPTOR : Drug
Mutagen
Reproductive Effector
Human
Primary Irritant
SYNONYMS/TRADE NAMES :
* Betadine
* Efo-dine
* Isodine
* Povidone-iodine
* PVP-iodine
* 2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine
* Ultradine
* 1-Vinyl-2-pyrrolidinone polymer, compd. with iodine
*** HEALTH HAZARD DATA ***
** SKIN/EYE IRRITATION DATA **
TYPE OF TEST : Standard Draize test
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 500 mg
REACTION SEVERITY : Mild
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 17(Suppl 1),75,1989
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Human
DOSE/DURATION : 3400 mg/kg/24H
TOXIC EFFECTS :
Blood - hemorrhage
Skin and Appendages - dermatitis, other (after systemic exposure)
REFERENCE :
JAMAAP JAMA, Journal of the American Medical Association. (AMA, 535 N.
Dearborn St., Chicago, IL 60610) V.1- 1883- Volume(issue)/page/year:
240,249,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >8 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,788,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 3450 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,788,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 640 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,788,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 8100 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,788,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 4100 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,788,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 480 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,788,1982
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 1450 mg/kg
SEX/DURATION : female 15-22 day(s) after conception
lactating female 3 week(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - biochemical and metabolic
Reproductive - Effects on Newborn - physical
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 22,4663,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 11600 mg/kg
SEX/DURATION : female 15-22 day(s) after conception
lactating female 3 week(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - live birth index (measured after birth)
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 :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 22,4663,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 11600 mg/kg
SEX/DURATION : female 15-22 day(s) after conception
lactating female 3 week(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
Reproductive - Effects on Newborn - other postnatal measures or effects
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 22,4663,1988
** MUTATION DATA **
TYPE OF TEST : DNA repair
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 1 uL/disc
REFERENCE :
JPMSAE Journal of Pharmaceutical Sciences. (American Pharmaceutical Assoc.,
2215 Constitution Ave., NW, Washington, DC 20037) V.50- 1961-
Volume(issue)/page/year: 64,1235,1975
TYPE OF TEST : DNA damage
TEST SYSTEM : Human Cells - not otherwise specified
DOSE/DURATION : 200 ppm
REFERENCE :
JTEHD6 Journal of Toxicology and Environmental Health. (Hemisphere Pub.,
1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76-
Volume(issue)/page/year: 1,977,1976
TYPE OF TEST : Morphological transformation
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 5000 ppm
REFERENCE :
APTOD9 Abstracts of Papers, Society of Toxicology. Annual Meetings.
(Academic Press, Inc., 1 E. First St., Duluth, MN 55802)
Volume(issue)/page/year: 19,A106,1980
TYPE OF TEST : Mutation in mammalian somatic cells
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 5000 ppm
REFERENCE :
APTOD9 Abstracts of Papers, Society of Toxicology. Annual Meetings.
(Academic Press, Inc., 1 E. First St., Duluth, MN 55802)
Volume(issue)/page/year: 19,A106,1980
*** 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 - M0524
No. of Facilities: 1794 (estimated)
No. of Industries: 14
No. of Occupations: 15
No. of Employees: 65694 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X7540
No. of Facilities: 7099 (estimated)
No. of Industries: 35
No. of Occupations: 49
No. of Employees: 1075065 (estimated)
No. of Female Employees: 939668 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X9186
No. of Facilities: 798 (estimated)
No. of Industries: 3
No. of Occupations: 16
No. of Employees: 94521 (estimated)
No. of Female Employees: 86562 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Positive: E coli polA without S9
EPA GENETOX PROGRAM 1988, Inconclusive: Mammalian micronucleus; Histidine
reversion-Ames test
EPA TSCA Section 8(b) CHEMICAL INVENTORY
*** END OF RECORD ***