NOAEL Studies Emulsifier

Sorbitan Stearate NOAEL Studies

INCI: SORBITAN STEARATE

CAS: 1338-41-6

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 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral 20 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 1250 mg/kg bw/day dog oral 600 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2500 mg/kg bw/day rat oral 84 day Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 5000 mg/kg bw/day rat oral 720 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =2600 mg/kg bw/day Mouse oral: feed 560 days chronic/long term toxicity EFSA ANS - 2017 - OutputID 2957 - body weight - systemic - Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives - doi:10.2903/j.efsa.2017.4788
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =10 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2017 - OutputID 2957 - Consumers - Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives - doi:10.2903/j.efsa.2017.4788
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =10 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2017 - OutputID 2957 - Consumers - Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives - doi:10.2903/j.efsa.2017.4788
NTP_ICE_acute_oral 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >2000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_2312; row=2810; data_type=In Vivo; mixture=Chemical; chemical_name=Sorbitan, monooctadecanoate; preferred_name=Anhydrosorbitol stearate; dtxsid=DTXSID1027396; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1027396; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >15900 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_2314; row=2811; data_type=In Vivo; mixture=Chemical; chemical_name=Sorbitan, monooctadecanoate; preferred_name=Anhydrosorbitol stearate; dtxsid=DTXSID1027396; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1027396; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >31000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_2316; row=2809; data_type=In Vivo; mixture=Chemical; chemical_name=Sorbitan, monooctadecanoate; preferred_name=Anhydrosorbitol stearate; dtxsid=DTXSID1027396; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1027396; source_file=acute_oral.xlsx
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL >638 mg/kg bw/day Dog oral chronic; 20 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6d5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5384/7/6/2?documentUUID=a3486de8-d308-445e-9c95-be31a71016a4; YEAR=1963; ORIGINAL_YEAR=1963; STUDY_GROUP=ECHA IUCLID:15847591:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_156bdc267f8ad7dd54132686fa083a90
ToxValDB_ECHA_IUCLID NOAEL >=1000 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd26b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5384/7/9/3?documentUUID=a3486de8-d308-445e-9c95-be31a71016a4; YEAR=1963; ORIGINAL_YEAR=1963; STUDY_GROUP=ECHA IUCLID:15824686:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_634344d5065563cb28d542138c76bc86
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =2600 mg/kg bw/day Mouse oral chronic; 80 weeks chronic LONG_REF=EFSA ANS (2017). Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives. doi:10.2903/j.efsa.2017.4788.; TITLE=Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4788; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15625114: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_e4e29f85e36e3c25ed7518449b17c088
ToxValDB_HESS 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_HESS NOEL =1000 mg/kg bw/day Rat oral subchronic; 42 days subchronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0dc5e4b0a676289dd341; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; YEAR=2007; ORIGINAL_YEAR=2007; STUDY_GROUP=HESS:15638369:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_952c3cac466a193702a774c18fb93f45
ToxValDB_HPVIS 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_HPVIS LOAEL =485 mg/kg bw/day Dog oral chronic; 21 months chronic QUALITY=4; EXTERNAL_SOURCE_ID=63796; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; STUDY_GROUP=HPVIS:15640294:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2be0523852b484d1dd97324c39ddba03
ToxValDB_HPVIS NOAEL =0.5 % diet Mouse dermal chronic; 80 weeks chronic QUALITY=4; EXTERNAL_SOURCE_ID=64315; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; STUDY_GROUP=HPVIS:15639510:-:--; 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_7dbac4bf4bdc5281ed29c1ee2437122e
ToxValDB_HPVIS NOAEL =5 % diet Dog dermal chronic; 20 months chronic QUALITY=4; EXTERNAL_SOURCE_ID=64052; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; STUDY_GROUP=HPVIS:15640298:-:--; 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_304131fe556017bb329d1b0547469324
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=25 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650b0414e4b0d99f5a889249; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2271; YEAR=2020; ORIGINAL_YEAR=2020; STUDY_GROUP=WHO JECFA ADI:15715787:-:--; 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_6e47aacecc8eca220cceb299ffd8dfba
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier NVZ4I0H58X UNII - - - chemical {"approval_status":null,"molecular_formula":"C24H46O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"NVZ4I0H58X"}
openFDA substances FDA UNII substance identifier NVZ4I0H58X UNII - - - chemical {"approval_status":null,"molecular_formula":"C24H46O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"NVZ4I0H58X"}
openFDA substances FDA UNII substance identifier NVZ4I0H58X UNII - - - chemical {"approval_status":null,"molecular_formula":"C24H46O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"NVZ4I0H58X"}
openFDA substances FDA UNII substance identifier NVZ4I0H58X UNII - - - chemical {"approval_status":null,"molecular_formula":"C24H46O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"NVZ4I0H58X"}