The Registry of Toxic Effects of Chemical Substances

Urea

RTECS #: YR6250000

CAS #: 57-13-6

UPDATE: August 2003 MW: 60.07 MF: CH4N2O


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. SKIN AND EYE IRRITATION DATA:
  3. MUTATION DATA:
  4. REPRODUCTIVE EFFECTS DATA:
  5. TUMORIGENIC DATA:
  6. ACUTE TOXICITY DATA:
  7. OTHER MULTIPLE DOSE DATA:
  8. STANDARDS AND REGULATIONS:
  9. NIOSH DOCUMENTATION AND SURVEILLANCE:
  10. STATUS IN FEDERAL AGENCIES:
  11. REFERENCES:

SYNONYMS:

  1. B - I - K
  2. Carbamide
  3. Carbamide resin
  4. Carbamimidic acid
  5. Carbonyl diamide
  6. Carbonyldiamine
  7. Harnstoff (German)
  8. Isourea
  9. Mocovina (Czech)
  1. NCI - C02119
  2. Prespersion, 75 urea
  3. Pseudourea
  4. Supercel 3000
  5. Ureaphil
  6. Ureophil
  7. Urevert
  8. Varioform II


SKIN AND EYE IRRITATION DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
skin
human 		22 mg/3 day- intermittent mild 85DKA8 -,127,1977
skin
human 		20%/24 hour moderate JOCMA7 177,44,1992


MUTATION DATA AND REFERENCES:

SYSTEM TEST ROUTE/
ORGANISM/
TISSUE 		DOSE REFERENCE
cytogenetic analysis hamster fibroblast 16 gm/L/24 hour MUREAV 48,337,1977
cytogenetic analysis hamster lung 13 gm/L GMCRDC 27,95,1981
cytogenetic analysis human leukocyte 50 mmol/L CNREA8 25,980,1965
cytogenetic analysis oral
mouse 		100 gm/kg/5 day- continuous CYTOAN 52,877,1987
DNA damage hamster fibroblast 8 mole/L SFCRAO 23,346,1970
DNA damage mouse lymphocyte 628 mmol/L MUREAV 203,155,1988
DNA inhibition human lymphocyte 600 mmol/L PNASA6 79,1171,1982
mutation in mammalian somatic cells mouse lymphocyte 265 mmol/L MUTAEX 3,193,1988


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intraplacental
woman 		lowest published toxic dose: 1,400 mg/kg (16 week pregnant) Reproductive: Effects on fertility: Abortion OBGNAS 43,765,1974
intraplacental
woman 		lowest published toxic dose: 1,600 mg/kg (16 week pregnant) Reproductive: Effects on fertility: Abortion BJCPAT 26,24,1972
intraplacental
woman 		lowest published toxic dose: 1,600 mg/kg (16 week pregnant) Reproductive: Effects on fertility: Abortion BMJOAE 1,28,1971
intrauterine
monkey 		lowest published toxic dose: 6 gm/kg (18 week pregnant) Reproductive: Effects on fertility: Abortion IJEBA6 12,372,1974


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
oral
mouse 		lowest published toxic dose: 394 gm/kg/1 year- continuous Tumorigenic: Carcinogenic by RTECS criteria

Blood: Tumors

Blood: Lymphoma including Hodgkin's disease 		JEPTDQ 3(5-6),149,1980
oral
rat 		lowest published toxic dose: 821 gm/kg/1 year- continuous Tumorigenic: Neoplastic by RTECS criteria

Blood: Tumors

Blood: Lymphoma including Hodgkin's disease 		JEPTDQ 3(5-6),149,1980


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intraperitoneal
mouse 		lowest published lethal dose: 6,608 mg/kg Behavioral: Convulsions or effect on seizure threshold

Behavioral: Coma 		JPETAB 57,19,1936
intraperitoneal
rat 		lethal dose (50 percent kill): >5 gm/kg N/R APEPA2 257,296,1967
intratracheal
rat 		lethal dose (50 percent kill): 567 mg/kg Behavioral: Convulsions or effect on seizure threshold

Lung, Thorax, or Respiration: Dyspnea

Blood: Methemoglobinemia- Carboxhemoglobinemia 		GTPZAB 30(3),43,1986
intravenous
dog 		lowest published lethal dose: 3 gm/kg N/R HBAMAK 4,1353,1935
intravenous
mouse 		lethal dose (50 percent kill): 4,600 mg/kg Behavioral: Altered sleep time (including change in righting reflex)

Behavioral: Change in motor activity (specific assay)

Behavioral: Antipsychotic 		OYYAA2 13,749,1977
intravenous
rat 		lethal dose (50 percent kill): 5,300 mg/kg Behavioral: Altered sleep time (including change in righting reflex)

Behavioral: Change in motor activity (specific assay)

Behavioral: Antipsychotic 		OYYAA2 13,749,1977
intravenous
rabbit 		lowest published lethal dose: 4,800 mg/kg N/R HBAMAK 4,1353,1935
oral
cattle 		lowest published toxic dose: 200 mg(N)/kg Behavioral: Tremor

Behavioral: Muscle weakness

Gastrointestinal: Alteration in gastric secretion 		JANSAG 45,566,1977
oral
domestic animal 		lowest published lethal dose: 511 mg/kg Behavioral: Tetany

Lung, Thorax, or Respiration: Dyspnea

Gastrointestinal: Changes in structure or function of salivary glands 		AJPHAP 153,41,1948
oral
mouse 		lethal dose (50 percent kill): 11 gm/kg N/R GTPZAB 31(12),53,1987
oral
rat 		lethal dose (50 percent kill): 8,471 mg/kg N/R GISAAA 51(6),8,1986
oral
rabbit 		lowest published lethal dose: 10 gm/kg Brain and Coverings: Other degenerative changes

Lung, Thorax, or Respiration: Structural or functional change in trachea or bronchi

Blood: Hemorrhage 		NJUZA9 15,125,1953
subcutaneous
dog 		lowest published lethal dose: 3 gm/kg N/R HBAMAK 4,1353,1935
subcutaneous
frog 		lowest published lethal dose: 600 mg/kg N/R HBAMAK 4,1353,1935
subcutaneous
mouse 		lethal dose (50 percent kill): 9,200 mg/kg Behavioral: Altered sleep time (including change in righting reflex)

Behavioral: Change in motor activity (specific assay)

Behavioral: Antipsychotic 		OYYAA2 13,749,1977
subcutaneous
pigeon 		lowest published lethal dose: 14,800 mg/kg N/R FDWU** -,-,1931
subcutaneous
rat 		lethal dose (50 percent kill): 8,200 mg/kg Behavioral: Altered sleep time (including change in righting reflex)

Behavioral: Change in motor activity (specific assay)

Behavioral: Antipsychotic 		OYYAA2 13,749,1977
subcutaneous
rabbit 		lowest published lethal dose: 3 gm/kg N/R HBAMAK 4,1353,1935


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
inhalation
rat 		lowest published toxic concentration: 288 mg/m3/17 week- intermittent Kidney, Ureter, and Bladder: Other changes in urine composition

Blood: Other changes

Nutritional and Gross Metabolic: Changes in: Cl 		GTPZAB 30(3),43,1986
skin
rat 		lowest published toxic dose: 3,024 mg/kg/4 week- continuous Liver: Changes in liver weight

Endocrine: Changes in thymus weight

Related to Chronic Data: Changes in testicular weight 		OYYAA2 13,749,1977
skin
rat 		lowest published toxic dose: 37,800 mg/kg/25 week- continuous Brain and Coverings: Changes in brain weight

Related to Chronic Data: Changes in prostate weight 		OYYAA2 13,749,1977


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
N/R N/R N/R


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1998 STATUS OF PESTICIDES: Cancelled RBREV* -,343,1998


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 80231;
Number of Industries 156;
Total Number of Facilities 22,367;
Number of Occupations 119;
Total Number of Employees Exposed 284,911
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: X7915;
Number of Industries 1;
Total Number of Facilities 9;
Number of Occupations 1;
Total Number of Employees Exposed 63;
Total Number of Female Employees Exposed 9
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 80231;
Number of Industries 204;
Total Number of Facilities 31,269;
Number of Occupations 164;
Total Number of Employees Exposed 783,504;
Total Number of Female Employees Exposed 326,824


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
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
Used in ceramics, cosmetics, ISOCYANURATES, paper processing, plastics, resins, adhesives
EPA TSCA Section 8(d) unpublished health/safety studies
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001


REFERENCES:

CODEN
REFERENCE
85DKA8 "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977
AJPHAP American Journal of Physiology. (American Physiological Soc., 9650 Rockville Pike, Bethesda, MD 20814) V.1- 1898-
APEPA2 Naunyn-Schmiedebergs Archiv fuer Pharmakologie und Experimentelle Pathologie. (Berlin, Ger.) V.254-263, 1966-69. For publisher information, see NSAPCC.
BJCPAT British Journal of Clinical Practice. (Medical News Group, 1 Bedford St., London WC2E 9HD, UK) V.10(10)- 1956-
BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857-
CNREA8 Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941-
CYTOAN Cytologia. (Japan Pub. Trading Co. (USA), 1255 Howard St., San Francisco, CA 94103) V.1- 1929-
FDWU** "Ueber die Wirkung Verschiedener Gifte Auf Vogel, Dissertation," Forchheimer, L., Pharmakologischen Institut der Universitat Wurzburg, Fed. Rep. Ger., 1931
GISAAA Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936-
GMCRDC Gann Monograph on Cancer Research. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) No. 11- 1971-
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
HBAMAK "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig, Ger. Dem. Rep.)
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
JANSAG Journal of Animal Science. (American Soc. of Animal Science, 309 W. Clark St., Champaign, IL 61820) V.1- 1942-
JEPTDQ Journal of Environmental Pathology and Toxicology. (Park Forest South, IL) V.1-5(3), 1977-81(?). For publisher information, see JEPOEC.
JOCMA7 Journal of Occupational Medicine. (Chicago, IL) V.1-9, 1957-67. For publisher information, see:JJOMDZ
JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10-
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
MUTAEX Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1986-
NJUZA9 Japanese Journal of Veterinary Science. (Nippon Jui Gakkai, 1-37-20 Yoyogi, Shibuya-ku, Tokyo 151, Japan) V.1- 1939-
OBGNAS Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52 Vanderbilt Ave., New York, NY 10017) V.1- 1953-
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967-
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-
RBREV* Status of Pesticides in Registration, Reregistration, and Special Review (Rainbow Report), Special Review and Reregistration Division Office of Pesticide Programs U.S. Environmental Protection Agency, 401 M. Street, S.W., Washington, D.C. 20460, Spring 1998
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.

Used in ceramics, cosmetics, ISOCYANURATES, paper processing, plastics, resins, adhesives

Top 50 chemical production: 16.84 billions lbs in 1992, 16.27 billions in 1991

NIOSH PROFILE (FERTILIZER MANUFACTURE), SRC, 3/80

NIOSH PROFILE (LEATHER TANNING), SRI, 2/77

FDA-over the counter and proprietary drug

RTECS Compound Description:
   Tumorigen
   Drug
   Mutagen
   Reproductive Effector
   Human Data
   Primary Irritant

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