NOAEL Studies
Emulsifier
Polysorbate 20 NOAEL Studies
INCI: POLYSORBATE 20
CAS: 9005-64-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 17 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | DERMAL_ABSORPTION | =3.43 | % | Hairless mouse | dermal | 5% | Franz cells | 42, p.6 |
| CIR Safety Assessment | NOAEL | =250 | mg/kg/d | rat | oral | 14-day | repeated dose toxicity | 5); 4; 22, p.7 |
| CIR Safety Assessment | NOAEL | =10 | mg/kg/d | rat | oral | 1 month | repeated dose toxicity | 20; 22; 4, p.7 |
| CIR Safety Assessment | NOAEL | =0.2 | % | rat | oral | 1 month | repeated dose toxicity | 420; 22; 4, p.7 |
| CIR Safety Assessment | NOAEL | =14285.71 | mg/kg/d | rat | oral | 1 month | repeated dose toxicity | 11); 44; 20, p.7 |
| CIR Safety Assessment | NOAEL | =7693 | mg/kg/d | rat | oral | 28 days | developmental toxicity | 28; 5; 20, p.7 |
| CIR Safety Assessment | NOAEL | =1600 | mg/kg/d | C57BL/6J mice | Oral (gavage) | 28 days | General toxicity | 46, p.7 |
| CIR Safety Assessment | NOAEL | =0.15 | g/kg/d | Sprague-Dawley rats | Gavage | 5 days | General toxicity | 45, p.7 |
| CIR Safety Assessment | NOAEL | =5 | mL/kg/d | Dog | Oral | 90 days | General toxicity | 44, p.43 |
| CIR Safety Assessment | NOAEL | =5 | mL/kg | Primate | Oral | Efficacy (distinct time not indicated.) | General toxicity | 44, p.43 |
| CIR Safety Assessment | NOAEL | =10 | mL/kg/d | Rat | Oral | 7 days | General toxicity | 44, p.43 |
| CIR Safety Assessment | NOAEL | =10 | µL/nostril/d | Mouse | Intranasal | 3 days | General toxicity | 44, p.43 |
| CIR Safety Assessment | NOAEL | =100 | mg/kg | Rat | Intravenous | Not reported | General toxicity | 44, p.43 |
| CIR Safety Assessment | NOAEL | =350 | mg/kg | Rat | Oral | Not reported | General toxicity | 44, p.43 |
| CIR Safety Assessment | NOAEL | =3700 | mg/kg/d | Sprague-Dawley rats | Oral (gavage) | 28 days | General toxicity | 46, p.7 |
| CIR Safety Assessment | NOAEL | >5000 | mg/kg/d | Crl:CD BR VAF/PlusTM outbred albino rat | Gavage | Gestation days 6-15 | Reproductive and developmental toxicity | 23, p.7 |
| CIR Safety Assessment | NOAEL | =6400 | mg/kg/d | C57BL/6J mice | Oral (gavage) | 28 days | General toxicity | 46, p.7 |
COSMOS DB 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | NOAEL | 3000 | mg/kg bw/day | hamster | oral | 273 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 6000 | mg/kg bw/day | hamster | oral | 68 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 25000 | mg/kg bw/day | rat | oral | 147 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA 2 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 | 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 |
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 | 4 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1074; Record_ID=eye_irritation_173; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; 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/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949 |
| NTP ICE eye irritation | EPA Classification | 3 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1076; Record_ID=eye_irritation_173; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; 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/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949 |
| NTP ICE eye irritation | Intensity | 0.03 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1078; Record_ID=eye_irritation_1235; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Vitrigel; Endpoint=Intensity; Response=0.03; 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/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949 |
| NTP ICE eye irritation | Lag time | >180 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1077; Record_ID=eye_irritation_1235; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID3031949; 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/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949 |
| NTP ICE eye irritation | Plateau level | 0 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1079; Record_ID=eye_irritation_1235; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID3031949; 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/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949 |
openFDA substances 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 239B50Y732 | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 31JQ3WOL8T | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 4Z93U4C2WN | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 59IO08SBZU | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 7T1F30V5YH | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | I42X3Q0FMF | UNII | - | - | - | polymer | - |