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.
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 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | 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 | 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 | 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 |
| ECHA | 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 |
EFSA 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | 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 | 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 |
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 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 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 8W8T17847W | UNII | - | - | - | chemical | - |