NOAEL Studies Humectant

Urea NOAEL Studies

INCI: UREA

CAS: 57-13-6

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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COSMOS_DB 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 160 mg/kg bw/day sheep oral 1 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 230 mg/kg bw/day cattle oral 1 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 440 mg/kg bw/day cattle oral 1 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 900 mg/kg bw/day mouse oral 1 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2000 mg/kg bw/day rat oral 1 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2250 mg/kg bw/day rat oral 365 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 3309 mg/kg bw/day horse oral 1 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 5000 mg/kg bw/day rabbit oral 1 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 6750 mg/kg bw/day mouse oral 365 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 50000 mg/kg bw/day rat oral 14 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >1000 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6z; document=6eb408f8-d1a1-46cf-a8a9-b041ccb8ebe8_c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6d; document_key=6eb408f8-d1a1-46cf-a8a9-b041ccb8ebe8/c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2017; ReportDate=2017-01-20; basis=other:; key_result=true; entry_uuid=c708abde-552e-438b-bb14-f5af479f02d3
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL 500 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6z; document=ee35ba14-23e4-4831-bdbb-9960a891ebb8_c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6d; document_key=ee35ba14-23e4-4831-bdbb-9960a891ebb8/c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=1969; basis=other:; key_result=false; entry_uuid=76515f36-dba6-4dd6-9e6e-fa25c7faba17
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >1000 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6z; document=6eb408f8-d1a1-46cf-a8a9-b041ccb8ebe8_c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6d; document_key=6eb408f8-d1a1-46cf-a8a9-b041ccb8ebe8/c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2017; ReportDate=2017-01-20; basis=other:; key_result=true; entry_uuid=c708abde-552e-438b-bb14-f5af479f02d3
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL 500 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6z; document=ee35ba14-23e4-4831-bdbb-9960a891ebb8_c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6d; document_key=ee35ba14-23e4-4831-bdbb-9960a891ebb8/c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=1969; basis=other:; key_result=false; entry_uuid=76515f36-dba6-4dd6-9e6e-fa25c7faba17
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >1000 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6z; document=6eb408f8-d1a1-46cf-a8a9-b041ccb8ebe8_c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6d; document_key=6eb408f8-d1a1-46cf-a8a9-b041ccb8ebe8/c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2017; ReportDate=2017-01-20; basis=other:; key_result=true; entry_uuid=c708abde-552e-438b-bb14-f5af479f02d3
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL 500 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6z; document=ee35ba14-23e4-4831-bdbb-9960a891ebb8_c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9.i6d; document_key=ee35ba14-23e4-4831-bdbb-9960a891ebb8/c30fd74b-f53b-4aa4-8d93-ffae6cf4b0a9; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=1969; basis=other:; key_result=false; entry_uuid=76515f36-dba6-4dd6-9e6e-fa25c7faba17
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOEL =2250 mg/kg bw/day Rat - - reproduction toxicity EFSA - 2012 - OutputID 1322 - reproduction - reproductive - Conclusion on the peer review of the pesticide risk assessment of the active substance urea - doi:10.2903/j.efsa.2012.2523
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOEL =2250 mg/kg bw/day Rat - - reproduction toxicity EFSA - 2012 - OutputID 1322 - reproduction - reproductive - Conclusion on the peer review of the pesticide risk assessment of the active substance urea - doi:10.2903/j.efsa.2012.2523
NTP_ICE_acute_oral 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =15000 mg/kg bw Rat (Female) oral acute Rat Acute Oral Toxicity JRC AcutoxBase (undated); record_id=acute_oral_7811; row=7038; data_type=In Vivo; mixture=Chemical; chemical_name=Urea; preferred_name=Urea; dtxsid=DTXSID4021426; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021426; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4021426; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =8471 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_7809; row=7039; data_type=In Vivo; mixture=Chemical; chemical_name=Urea; preferred_name=Urea; dtxsid=DTXSID4021426; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021426; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4021426; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =14300 mg/kg bw Rat (Male) oral acute Rat Acute Oral Toxicity JRC AcutoxBase (undated); record_id=acute_oral_7810; row=7040; data_type=In Vivo; mixture=Chemical; chemical_name=Urea; preferred_name=Urea; dtxsid=DTXSID4021426; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021426; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4021426; source_file=acute_oral.xlsx
NTP_ICE_endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=16262; RecordID=ARPathway2016_1340; DatasetName=ARPathway2016; DTXSID=DTXSID4021426; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021426; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021426
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =8325 mg/kg bw/day Mouse oral chronic; 12 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cae3e4b0a7c65d223da1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10396/7/6/2?documentUUID=70724f52-2f58-4ae6-973a-70ee75b44bba; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=ECHA IUCLID:15832409:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_147349d1a51df0eb66b62ce90a475422
ToxValDB_ECHA_IUCLID NOAEL =3510 mg/kg bw/day Rat oral chronic; 12 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cae3e4b0a7c65d223dc4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10396/7/6/2?documentUUID=70724f52-2f58-4ae6-973a-70ee75b44bba; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=ECHA IUCLID:15834526:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8fb3972536c3a27a9e62a4595e3f3fc8
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOEL =2250 mg/kg bw/day Rat oral - reproduction developmental LONG_REF=EFSA (2012). Conclusion on the peer review of the pesticide risk assessment of the active substance urea. doi:10.2903/j.efsa.2012.2523.; TITLE=Conclusion on the peer review of the pesticide risk assessment of the active substance urea; AUTHOR=EFSA; DOI=doi:10.2903/j.efsa.2012.2523; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=reproduction; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=EFSA:15614142:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0e013df13c2b640d2bc76a8f621a82fc
ToxValDB_GESTIS_DNEL 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =3526 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15635646_15635647:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8aa0a2170acbc185c4a39d5ca2fa3bd0
ToxValDB_GESTIS_DNEL DNEL systemic =292 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15635646_15635647:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0d45c1defac3fa3ba4445d2c094f619d
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 8W8T17847W UNII - - - chemical {"approval_status":null,"molecular_formula":"CH4N2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8W8T17847W"}
openFDA substances FDA UNII substance identifier 8W8T17847W UNII - - - chemical {"approval_status":null,"molecular_formula":"CH4N2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8W8T17847W"}
openFDA substances FDA UNII substance identifier 8W8T17847W UNII - - - chemical {"approval_status":null,"molecular_formula":"CH4N2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8W8T17847W"}
openFDA substances FDA UNII substance identifier 8W8T17847W UNII - - - chemical {"approval_status":null,"molecular_formula":"CH4N2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8W8T17847W"}