NOAEL Studies Cosmetic Ingredient

Polysorbate 81 NOAEL Studies

INCI: POLYSORBATE 81

CAS: 9005-65-6

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

COSMOS DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 1000 mg/kg bw/day monkey oral 355 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2500 mg/kg bw/day rat oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral 720 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 7500 mg/kg bw/day mouse oral 14 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 10000 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =2500 mg/kg bw/day Rat oral: unspecified 721 days chronic/long term toxicity EFSA ANS - 2015 - OutputID 2782 - mortality - systemic - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA NOAEL =2500 mg/kg bw/day Rat oral: unspecified 721 days chronic/long term toxicity EFSA ANS - 2015 - OutputID 2782 - mortality - systemic - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA ADI (group) =25 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2015 - OutputID 2782 - Consumers - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA ADI (group) =25 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2015 - OutputID 2782 - Consumers - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA NOAEL =2500 mg/kg bw/day Rat oral chronic; 103 weeks chronic LONG_REF=EFSA ANS (2015). Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives. doi:10.2903/j.efsa.2015.4152.; TITLE=Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2015.4152; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=EFSA:15624471: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_8e00f56490122fb0c11cfcc86c2b71ca
NTP ICE cancer 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE cancer POLY-3 lowest dose 50000 ppm Rat Dosed feed - In Vivo; Two year cancer bioassay sheet=Data; excel_row=415; Record_ID=cancer_4806; Data_Type=In Vivo; Formulation_Name=Polysorbate 80 (glycol); Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Two year cancer bioassay; Endpoint=POLY-3 lowest dose; Response=50000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Route=Dosed feed; Level_of_Evidence=Equivocal evidence; Tissue=Adrenal gland medulla; Lesion=Pheochromocytoma(Benign, complex, malignant); Reference=TR-415; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr415/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE cancer Top dose 5 % Rat Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=408; Record_ID=cancer_4809; Data_Type=In Vivo; Formulation_Name=Polysorbate 80 (Glycol); Mixture=Chemical; DTXSID=DTXSID0021175; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=5; Response_Unit=%; Species=Rat; Strain=F344/N; Sex=Female; Route=Dosed feed; Reference=TR-415; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr415/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
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=13520; RecordID=ARPathway2016_1698; DatasetName=ARPathway2016; DTXSID=DTXSID0021175; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE eye irritation 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE eye irritation Draize rabbit irritation score 0 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=76; Record_ID=eye_irritation_178; Data_Type=In Vivo; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=0; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE eye irritation EPA Classification 4 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=74; Record_ID=eye_irritation_178; Data_Type=In Vivo; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=4; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE eye irritation Intensity 0.02 %/sec - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=78; Record_ID=eye_irritation_1307; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Vitrigel; Endpoint=Intensity; Response=0.02; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE eye irritation Lag time >180 s - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=77; Record_ID=eye_irritation_1307; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Vitrigel; Endpoint=Lag time; Response_Modifier=>; Response=180; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE eye irritation Plateau level 0 % - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=79; Record_ID=eye_irritation_1307; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Vitrigel; Endpoint=Plateau level; Response=0; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin irritation 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin irritation Positive reaction 3.5 % Human Dermal - In Vivo; Four-hour Human Patch Test sheet=Data_invivo; excel_row=79; Record_ID=skin_irritation_invivo_81; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Four-hour Human Patch Test; Endpoint=Positive reaction; Response=3.5; Response_Unit=%; Species=Human; Reference=Basketter et al. 2004; 15291823; 10.1111/j.0105-1873.2004.00385.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin irritation Positive reaction 3.8 % Human Dermal - In Vivo; Four-hour Human Patch Test sheet=Data_invivo; excel_row=80; Record_ID=skin_irritation_invivo_82; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Four-hour Human Patch Test; Endpoint=Positive reaction; Response=3.8; Response_Unit=%; Species=Human; Reference=Robinson et al. 2001; 11422260; 10.1034/j.1600-0536.2001.045001001.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization 18 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin sensitization CD86, EC150 8.73 ug/mL - Dermal - In Vitro; CE_USENSE2018; U-SENS sheet=Data_invitro; excel_row=8636; Record_ID=skin_sensitization_invitro_2388; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=8.73; Reported_Response_Unit=ug/mL; Response=8.73; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization CV70 >200 ug/mL - Dermal - In Vitro; CE_USENSE2018; U-SENS sheet=Data_invitro; excel_row=8634; Record_ID=skin_sensitization_invitro_2388; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=U-SENS; Endpoint=CV70; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=200; Reported_Response_Unit=ug/mL; Response=200; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization CV75 5000 ug/mL - Dermal - In Vitro; Urbisch_SkinSensitization2020; h-CLAT sheet=Data_invitro; excel_row=1670; Record_ID=skin_sensitization_invitro_461; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=h-CLAT; Endpoint=CV75; Reported_Response=5000; Reported_Response_Unit=ug/mL; Response=5000; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Depletion Cys 10.2 % - Dermal - In Vitro; Urbisch_SkinSensitization2020; DPRA sheet=Data_invitro; excel_row=246; Record_ID=skin_sensitization_invitro_67; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=10.2; Reported_Response_Unit=%; Response=10.2; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Depletion Lys 0 % - Dermal - In Vitro; Urbisch_SkinSensitization2020; DPRA sheet=Data_invitro; excel_row=220; Record_ID=skin_sensitization_invitro_67; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0; Reported_Response_Unit=%; Response=0; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization EC1.5 <65.91 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=8015; Record_ID=skin_sensitization_invitro_1812; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=LuSens; Endpoint=EC1.5; Response_Modifier=<; Reported_Response_Modifier=<; Reported_Response=65.91; Reported_Response_Unit=uM; Response=65.91; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization EC1.5 115.4742 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; KeratinoSens sheet=Data_invitro; excel_row=6911; Record_ID=skin_sensitization_invitro_1636; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=115.4742; Reported_Response_Unit=uM; Response=115.4742; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization EC1.5 115.5 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=6913; Record_ID=skin_sensitization_invitro_1637; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=115.5; Reported_Response_Unit=uM; Response=115.5; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization EC3 677.4 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=6915; Record_ID=skin_sensitization_invitro_1637; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=EC3; Reported_Response=677.4; Reported_Response_Unit=uM; Response=677.4; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization IC50 >164 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7644; Record_ID=skin_sensitization_invitro_1812; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=LuSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=164; Reported_Response_Unit=uM; Response=164; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization IC50 813.1 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=6919; Record_ID=skin_sensitization_invitro_1637; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=813.1; Reported_Response_Unit=uM; Response=813.1; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization IC50 4000 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; KeratinoSens sheet=Data_invitro; excel_row=6917; Record_ID=skin_sensitization_invitro_1636; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=4000; Reported_Response_Unit=uM; Response=4000; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Imax 3.08 ratio - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=6921; Record_ID=skin_sensitization_invitro_1637; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=3.08; Reported_Response_Unit=Unitless; Response=3.08; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Imax 3.085 ratio - Dermal - In Vitro; Urbisch_SkinSensitization2020; KeratinoSens sheet=Data_invitro; excel_row=6923; Record_ID=skin_sensitization_invitro_1636; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=3.08456; Reported_Response_Unit=Unitless; Response=3.085; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Imax 3.764 ratio - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7546; Record_ID=skin_sensitization_invitro_1812; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=LuSens; Endpoint=Imax; Reported_Response=3.764048241; Reported_Response_Unit=Unitless; Response=3.764; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Incidence of positive responses 0 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=10984; Record_ID=skin_sensitization_invivo_2401; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=25.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Magnusson and Kligman 1969; 5774356; 10.1038/jid.1969.42|Gad et al. 1986; 3715870; 10.1016/0041-008X(86)90419-9|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Induction dose per skin area 15520 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=10982; Record_ID=skin_sensitization_invivo_2401; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=25.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=15520; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Magnusson and Kligman 1969; 5774356; 10.1038/jid.1969.42|Gad et al. 1986; 3715870; 10.1016/0041-008X(86)90419-9|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
NTP ICE skin sensitization Relative reliability score 1 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=10988; Record_ID=skin_sensitization_invivo_2401; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=25.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID0021175; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=1; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Magnusson and Kligman 1969; 5774356; 10.1038/jid.1969.42|Gad et al. 1986; 3715870; 10.1016/0041-008X(86)90419-9|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0021175; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0021175
EPA ToxRefDB v3 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EPA ToxRefDB v3 LEL >2500 mg/kg bw/day rat (fischer; Fischer 344) oral 0 day to 2 year CHR study_id=7412; toxval_study_source_id=studyid7412_Adult_F0_F_NA; dose_level=2; study_year=1992; study_citation=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic rat); dsstox_substance_id=DTXSID0021175; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
EPA ToxRefDB v3 LEL =7500 mg/kg bw/day mouse (b6c3f1; B6C3F1) oral 0 day to 2 year CHR study_id=7411; toxval_study_source_id=studyid7411_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-ulcer|pathology microscopic-stomach-inflammation|in life observation-body weight-body weight; dose_level=2; study_year=1992; study_citation=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic mouse); dsstox_substance_id=DTXSID0021175; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
EPA ToxRefDB v3 NEL =1250 mg/kg bw/day rat (fischer; Fischer 344) oral 0 day to 2 year CHR study_id=7412; toxval_study_source_id=studyid7412_Adult_F0_M_systemic; toxval_effect_list=pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|pathology microscopic-adrenal gland-pheochromocytoma benign; dose_level=1; study_year=1992; study_citation=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic rat); dsstox_substance_id=DTXSID0021175; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
EPA ToxRefDB v3 NEL =3750 mg/kg bw/day mouse (b6c3f1; B6C3F1) oral 0 day to 2 year CHR study_id=7411; toxval_study_source_id=studyid7411_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-inflammation|pathology microscopic-stomach-ulcer; dose_level=1; study_year=1992; study_citation=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic mouse); dsstox_substance_id=DTXSID0021175; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxValDB ECOTOX 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX NOEL =0.5 % Mouse injection acute; 0.6667 days acute LONG_REF=Teratog. Carcinog. Mutagen.19(5): 323-327 Przybojewska,B. Assessment of Aniline Derivatives-Induced DNA Damage in the Liver Cells of B6C3F1 Mice Using the Alkaline Single Cell Gel Electrophoresis (\"Comet\") Assay 1999; TITLE=Assessment of Aniline Derivatives-Induced DNA Damage in the Liver Cells of B6C3F1 Mice Using the Alkaline Single Cell Gel Electrophoresis ("Comet") Assay; AUTHOR=Przybojewska,B.; DOI=10.1002/(sici)1520-6866(1999)19:5<323::aid-tcm2>3.0.co;2-c; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=111819; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1999; ORIGINAL_YEAR=1999; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15602277:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b308da6db3651a466efc4b4396e06768
ToxValDB HESS 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB HESS NOEL =4800 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0defe4b0a676289de90e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; STUDY_GROUP=HESS:15638662: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_43b1c007b42122c973f92dea1ff1415d
ToxValDB ToxRefDB 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ToxRefDB LEL =7500 mg/kg bw/day Mouse oral chronic; 2 years chronic LONG_REF=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic mouse); TITLE=Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies); AUTHOR=NTP; EXTERNAL_SOURCE_ID=7411; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-stomach-ulcer|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15712594_15712595_15712596_15712597:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7c4f8629f82108336e68a52f51d4f1d4
ToxValDB ToxRefDB NEL =1250 mg/kg bw/day Rat oral chronic; 2 years chronic LONG_REF=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic rat); TITLE=Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies); AUTHOR=NTP; EXTERNAL_SOURCE_ID=7412; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|systemic: pathology microscopic-adrenal gland-pheochromocytoma benign; TOXICOLOGICAL_EFFECT_CATEGORY=cancer|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15712606_15712607_15712608_15712609:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2b79cad9f9b28c28b23b3192bd8c4fc6
ToxValDB ToxRefDB NEL =3750 mg/kg bw/day Mouse oral chronic; 2 years chronic LONG_REF=NTP. (1992) Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP TR 415, NIH Publication No. 92-3146. (Chronic mouse); TITLE=Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies); AUTHOR=NTP; EXTERNAL_SOURCE_ID=7411; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-stomach-hyperplasia|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-stomach-ulcer; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15712594_15712595_15712596_15712597:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cc55bdc6a3568bca705b4d597168954b
openFDA substances 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 2MSF640LWM UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"2MSF640LWM"}
openFDA substances FDA UNII substance identifier 2MSF640LWM UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"2MSF640LWM"}
openFDA substances FDA UNII substance identifier 2MSF640LWM UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"2MSF640LWM"}
openFDA substances FDA UNII substance identifier 2MSF640LWM UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"2MSF640LWM"}
openFDA substances FDA UNII substance identifier 58O7V09UCI UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"58O7V09UCI"}
openFDA substances FDA UNII substance identifier 58O7V09UCI UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"58O7V09UCI"}
openFDA substances FDA UNII substance identifier 58O7V09UCI UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"58O7V09UCI"}
openFDA substances FDA UNII substance identifier 58O7V09UCI UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"58O7V09UCI"}
openFDA substances FDA UNII substance identifier 6OZP39ZG8H UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6OZP39ZG8H"}
openFDA substances FDA UNII substance identifier 6OZP39ZG8H UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6OZP39ZG8H"}
openFDA substances FDA UNII substance identifier 6OZP39ZG8H UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6OZP39ZG8H"}
openFDA substances FDA UNII substance identifier 6OZP39ZG8H UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"6OZP39ZG8H"}