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Registry of Toxic Effects of Chemical Substances (RTECS)

Urea

RTECS #

YR6250000

CAS #

57-13-6

Updated

July 2013

Molecular Weight

60.07

Molecular Formula

CH4N2O

Synonyms

B-I-K
Carbamide
Carbamide resin
Carbamimidic acid
Carbonyl diamide
Carbonyldiamine
Harnstoff (German)
Isourea
Mocovina (Czech)
NCI-C02119
Prespersion, 75 urea
Pseudourea
Supercel 3000
Ureaphil
Ureophil
Urevert
Varioform II

Skin and Eye Irritation and References

Route/OrganismDoseEffectReference
skin /human 22 mg/3D- intermittent mild85DKA8 -,127,1977
skin /human 20%/24H moderateJOCMA7 177,44,1992

Mutation Data and Reference

System TestRoute/Organism/TissueDoseReference
Cytogenetic Analysisleukocyte/human50 mmol/LCNREA8 25,980,1965
Cytogenetic Analysisoral/mouse100 gm/kg/5D-continuousCYTOAN 52,877,1987
Cytogenetic Analysisfibroblast/hamster16 gm/L/24HMUREAV 48,337,1977
Cytogenetic Analysislung/hamster13 gm/LGMCRDC 27,95,1981
DNA Damageliver/human1 mmol/l/48HMUREAV 696,21,2010
DNA Damageliver/human31.6 µmol/l/48HMUREAV 696,21,2010
DNA Damagelymphocyte/mouse628 mmol/LMUREAV 203,155,1988
DNA Damagefibroblast/hamster8 mole/LSFCRAO 23,346,1970
DNA inhibitionlymphocyte/human600 mmol/LPNASA6 79,1171,1982
mutation in mammalian somatic cellslymphocyte/mouse265 mmol/LMUTAEX 3,193,1988

Reproductive Effects Data and References

Route/OrganismDoseEffectReference
intraplacental/woman 1400 mg/kg (16W pregnant)Reproductive: Effects on fertility: AbortionOBGNAS 43,765,1974
intraplacental/woman 1600 mg/kg (16W pregnant)Reproductive: Effects on fertility: AbortionBJCPAT 26,24,1972
intraplacental/woman 1600 mg/kg (16W pregnant)Reproductive: Effects on fertility: AbortionBMJOAE 1,28,1971
intrauterine/monkey 6 gm/kg (18W pregnant)Reproductive: Effects on fertility: AbortionIJEBA6 12,372,1974

Tumorigenic Data and References

Route/OrganismDoseEffectReference
oral/mouse lowest published toxic dose: 394 gm/kg/1Y- continuousTumorigenic: 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/1Y- continuousTumorigenic: Neoplastic by RTECS criteria

Blood: Tumors

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

Acute Toxicity Data and References

Route/OrganismDoseEffectReference
In Vitro/Human, liver tumor Inhibitor Concentration (50 percent kill): 279 mmol/L/24HIn Vitro Toxicity Studies: Cell protein synthesisTIVIEQ 3,189,1989
In Vitro/Human, melanoma Inhibitor Concentration (50 percent kill): 17959.7 mg/L/48HIn Vitro Toxicity Studies: Cell viability (lysosomal damage): neutral red assay etc.FCTOD7 50,2084,2012
In Vitro/Non-mammalian species, fibroblast Inhibitor Concentration (50 percent kill): 540 mmol/L/24HIn Vitro Toxicity Studies: Cell countingTIVIEQ 7,537,1993
intraperitoneal/mouse lowest published lethal dose: 6608 mg/kgBehavioral: Convulsions or effect on seizure threshold

Behavioral: Coma
JPETAB 57,19,1936
intraperitoneal/rat lethal dose (50 percent kill): >5 gm/kgAPEPA2 257,296,1967
intratracheal/rat lethal dose (50 percent kill): 567 mg/kgBehavioral: 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/kgHBAMAK 4,1353,1935
intravenous/mouse lethal dose (50 percent kill): 4600 mg/kgBehavioral: 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: 4800 mg/kgHBAMAK 4,1353,1935
intravenous/rat lethal dose (50 percent kill): 5300 mg/kgBehavioral: Altered sleep time (including change in righting reflex)

Behavioral: Change in motor activity (specific assay)

Behavioral: Antipsychotic
OYYAA2 13,749,1977
oral/cattle lowest published toxic dose: 200 mg(N)/kgBehavioral: Tremor

Behavioral: Muscle weakness

Gastrointestinal: Alteration in gastric secretion
JANSAG 45,566,1977
oral/domestic animal lowest published lethal dose: 511 mg/kgBehavioral: 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/kgGTPZAB 31(12),53,1987
oral/rabbit lowest published lethal dose: 10 gm/kgBrain and Coverings: Other degenerative changes

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

Blood: Hemorrhage
NJUZA9 15,125,1953
oral/rat lethal dose (50 percent kill): 8471 mg/kgGISAAA 51(6),8,1986
oral/rat lowest published toxic dose: 750 mg/kgKidney, Ureter, and Bladder: Urine volume increased

Kidney, Ureter, and Bladder: Other changes in urine composition

Nutritional and Gross Metabolic: Changes in: Na
FTRPAE 73,28,2002
oral/rat lowest published toxic dose: 750 mg/kgKidney, Ureter, and Bladder: Urine volume increased

Nutritional and Gross Metabolic: Changes in: Na

Nutritional and Gross Metabolic: Changes in: K
FTRPAE 77,83,2006
subcutaneous/Dog lowest published lethal dose: 3 gm/kgHBAMAK 4,1353,1935
subcutaneous/frog lowest published lethal dose: 600 mg/kgHBAMAK 4,1353,1935
subcutaneous/mouse lethal dose (50 percent kill): 9200 mg/kgBehavioral: 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: 14800 mg/kgFDWU** -,-,1931
subcutaneous/rabbit lowest published lethal dose: 3 gm/kgHBAMAK 4,1353,1935
subcutaneous/rat lethal dose (50 percent kill): 8200 mg/kgBehavioral: Altered sleep time (including change in righting reflex)

Behavioral: Change in motor activity (specific assay)

Behavioral: Antipsychotic
OYYAA2 13,749,1977

Other Multiple Dose Data and References

Route/OrganismDoseEffectReference
inhalation/rat lowest published toxic concentration: 288 mg/m3/17W- intermittentKidney, 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: 3024 mg/kg/4W- continuousLiver: 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: 37800 mg/kg/25W- continuousBrain and Coverings: Changes in brain weight

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

Reviews

OrganizationStandardReference
TOXICOLOGY REVIEWIJTOFN 24,1,2005
TOXICOLOGY REVIEWENTOX* -,409,2005
TOXICOLOGY REVIEWMUREAV 584,1,2005
TOXICOLOGY REVIEWCRTOEC 19,491,2006
TOXICOLOGY REVIEWMUREAV 723,101,2011
TOXICOLOGY REVIEWMUREAV 653,99,2008
TOXICOLOGY REVIEWMUREAV 721,27,2011

Standards and Regulations

OrganizationStandardReference
Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1998 STATUS OF PESTICIDESCancelledRBREV* -,343,1998
Occupational Exposure Limit-RUSSIAshort term exposure limit 10 mg/m3, JUN2003

NIOSH Documentation and Surveillance

OrganizationStandardReference
National Occupational Exposure Survey 1983Hazard 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 1983Hazard Code 80231; Number of Industries 204; Total Number of Facilities 31269; Number of Occupations 164; Total Number of Employees Exposed 783504; Total Number of Female Employees Exposed 326824
National Occupational Hazard Survey 1974Hazard Code 80231; Number of Industries 156; Total Number of Facilities 22367; Number of Occupations 119; Total Number of Employees Exposed 284911

Status in Federal Agencies

OrganizationReference
EPA GENETOX PROGRAM 1988, Inconclusive: E coli polA without S9
EPA GENETOX PROGRAM 1988, Negative: Sperm morphology-mouse
EPA GENETOX PROGRAM 1988, Positive: In vitro cytogenetics-human lymphocyte
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA Section 8(d) unpublished health/safety studies
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001
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