*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : YR6250000
CHEMICAL NAME : Urea
CAS REGISTRY NUMBER : 57-13-6
LAST UPDATED : 199710
DATA ITEMS CITED : 43
MOLECULAR FORMULA : C-H4-N2-O
MOLECULAR WEIGHT : 60.07
WISWESSER LINE NOTATION : ZVZ
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
Primary Irritant
SYNONYMS/TRADE NAMES :
* B-I-K
* Carbamide
* Carbamide resin
* Carbamimidic acid
* Carbonyl diamide
* Carbonyldiamine
* Harnstoff
* Isourea
* Mocovina
* NCI-C02119
* Prespersion, 75 urea
* Pseudourea
* Supercel 3000
* Ureaphil
* Ureophil
* Urevert
* Varioform II
*** 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 : 22 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 : 8471 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
GISAAA Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O
Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936-
Volume(issue)/page/year: 51(6),8,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
APEPA2 Naunyn-Schmiedebergs Archiv fuer Pharmakologie und Experimentelle
Pathologie. (Berlin, Ger.) V.254-263, 1966-69. For publisher information,
see NSAPCC. Volume(issue)/page/year: 257,296,1967
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 8200 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - changes in motor activity (specific assay)
Behavioral - antipsychotic
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 13,749,1977
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 5300 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - changes in motor activity (specific assay)
Behavioral - antipsychotic
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 13,749,1977
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intratracheal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 567 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Lungs, Thorax, or Respiration - dyspnea
Blood - methemoglobinemia-carboxyhemoglobin
REFERENCE :
GTPZAB Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and
Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR)
V.1-36, 1957-1992. For publisher information, see MTPEEI
Volume(issue)/page/year: 30(3),43,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 11 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
GTPZAB Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and
Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR)
V.1-36, 1957-1992. For publisher information, see MTPEEI
Volume(issue)/page/year: 31(12),53,1987
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 6608 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - coma
REFERENCE :
JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams &
Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10-
Volume(issue)/page/year: 57,19,1936
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 9200 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - changes in motor activity (specific assay)
Behavioral - antipsychotic
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 13,749,1977
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 4600 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - changes in motor activity (specific assay)
Behavioral - antipsychotic
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 13,749,1977
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 3 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
HBAMAK "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig,
Ger. Dem. Rep.) Volume(issue)/page/year: 4,1353,1935
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 3 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
HBAMAK "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig,
Ger. Dem. Rep.) Volume(issue)/page/year: 4,1353,1935
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 3 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
HBAMAK "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig,
Ger. Dem. Rep.) Volume(issue)/page/year: 4,1353,1935
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 4800 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
HBAMAK "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig,
Ger. Dem. Rep.) Volume(issue)/page/year: 4,1353,1935
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Bird - pigeon
DOSE/DURATION : 14800 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
FDWU** "Ueber die Wirkung Verschiedener Gifte Auf Vogel, Dissertation,"
Forchheimer, L., Pharmakologischen Institut der Universitat Wurzburg, Fed.
Rep. Ger., 1931 Volume(issue)/page/year: -,-,1931
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Amphibian - frog
DOSE/DURATION : 600 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
HBAMAK "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig,
Ger. Dem. Rep.) Volume(issue)/page/year: 4,1353,1935
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - domestic
DOSE/DURATION : 511 mg/kg
TOXIC EFFECTS :
Behavioral - tetany
Lungs, Thorax, or Respiration - dyspnea
Gastrointestinal - changes in structure or function of salivary glands
REFERENCE :
AJPHAP American Journal of Physiology. (American Physiological Soc., 9650
Rockville Pike, Bethesda, MD 20814) V.1- 1898- Volume(issue)/page/year:
153,41,1948
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TCLo - Lowest published toxic concentration
ROUTE OF EXPOSURE : Inhalation
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 288 mg/m3/17W-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - other changes in urine composition
Blood - other changes
Nutritional and Gross Metabolic - changes in chlorine
REFERENCE :
GTPZAB Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and
Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR)
V.1-36, 1957-1992. For publisher information, see MTPEEI
Volume(issue)/page/year: 30(3),43,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 3024 mg/kg/4W-C
TOXIC EFFECTS :
Liver - changes in liver weight
Endocrine - changes in thymus weight
Related to Chronic Data - changes in testicular weight
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 13,749,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 37800 mg/kg/25W-C
TOXIC EFFECTS :
Brain and Coverings - changes in brain weight
Related to Chronic Data - changes in prostate weight
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 13,749,1977
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 821 gm/kg/1Y-C
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Blood - tumors
Blood - lymphoma, including Hodgkin's disease
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: 3(5-6),149,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 394 gm/kg/1Y-C
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Blood - tumors
Blood - lymphoma, including Hodgkin's disease
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: 3(5-6),149,1980
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraplacental
SPECIES OBSERVED : Human - woman
DOSE : 1400 mg/kg
SEX/DURATION : female 16 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
OBGNAS Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1953- Volume(issue)/page/year:
43,765,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraplacental
SPECIES OBSERVED : Human - woman
DOSE : 1600 mg/kg
SEX/DURATION : female 16 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
BJCPAT British Journal of Clinical Practice. (Medical News Group, 1 Bedford
St., London WC2E 9HD, UK) V.10(10)- 1956- Volume(issue)/page/year:
26,24,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraplacental
SPECIES OBSERVED : Human - woman
DOSE : 1600 mg/kg
SEX/DURATION : female 16 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
1,28,1971
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intrauterine
SPECIES OBSERVED : Primate - monkey
DOSE : 6 gm/kg
SEX/DURATION : female 18 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information
Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
Volume(issue)/page/year: 12,372,1974
** MUTATION DATA **
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 600 mmol/L
REFERENCE :
PNASA6 Proceedings of the National Academy of Sciences of the United States
of America. (National Academy of Sciences, Printing & Pub. Office, 2101
Constitution Ave., Washington, DC 20418) V.1- 1915-
Volume(issue)/page/year: 79,1171,1982
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Human Leukocyte
DOSE/DURATION : 50 mmol/L
REFERENCE :
CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut
Sts., Philadelphia, PA 19106) V.1- 1941- Volume(issue)/page/year:
25,980,1965
TYPE OF TEST : DNA damage
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 628 mmol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 203,155,1988
TYPE OF TEST : Cytogenetic analysis
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 100 gm/kg/5D (Continuous)
REFERENCE :
CYTOAN Cytologia. (Japan Pub. Trading Co. (USA), 1255 Howard St., San
Francisco, CA 94103) V.1- 1929- Volume(issue)/page/year: 52,877,1987
TYPE OF TEST : Mutation in mammalian somatic cells
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 265 mmol/L
REFERENCE :
MUTAEX Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road,
Eynsham, Oxford OX8 1JJ, UK) V.1- 1986- Volume(issue)/page/year: 3,193,1988
TYPE OF TEST : DNA damage
TEST SYSTEM : Rodent - hamster Fibroblast
DOSE/DURATION : 8 mol/L
REFERENCE :
SFCRAO Collection of Papers Presented at the Annual Symposium on Fundamental
Cancer Research. (Baltimore, MD) V.1-29, 1946-76. For publisher
information, see AFCPDR. Volume(issue)/page/year: 23,346,1970
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - hamster Fibroblast
DOSE/DURATION : 16 gm/L/24H
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 : 13 gm/L
REFERENCE :
GMCRDC Gann Monograph on Cancer Research. (Plenum Pub. Corp., 233 Spring
St., New York, NY 10013) No. 11- 1971- Volume(issue)/page/year:
27,95,1981
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOHS - National Occupational Hazard Survey (1974)
NOHS Hazard Code - 80231
No. of Facilities: 22367 (estimated)
No. of Industries: 156
No. of Occupations: 119
No. of Employees: 284911 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X7915
No. of Facilities: 9 (estimated)
No. of Industries: 1
No. of Occupations: 1
No. of Employees: 63 (estimated)
No. of Female Employees: 9 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - 80231
No. of Facilities: 31269 (estimated)
No. of Industries: 204
No. of Occupations: 164
No. of Employees: 783504 (estimated)
No. of Female Employees: 326824 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Positive: In vitro cytogenetics-human lymphocyte
EPA GENETOX PROGRAM 1988, Negative: Sperm morphology-mouse
EPA GENETOX PROGRAM 1988, Inconclusive: E coli polA without S9
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 ***