NOAEL Studies
Cosmetic Ingredient
Potassium Acesulfame NOAEL Studies
INCI: POTASSIUM ACESULFAME
CAS: 55589-62-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS DB 21 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 10000 | mg/kg bw/day | rat | oral | 90 day | Subchronic | PAFA; FAP |
| COSMOS DB | NOAEL | 300 | mg/kg bw/day | rat | oral | 60 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 750 | mg/kg bw/day | dog | oral | 728 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 900 | mg/kg bw/day | rabbit | oral | 13 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 1500 | mg/kg bw/day | rat | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 3000 | mg/kg bw/day | rat | oral | NA | Multigeneration Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 4500 | mg/kg bw/day | mouse | oral | 560 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 4700 | mg/kg bw/day | mouse | oral | 280 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5543 | mg/kg bw/day | rat | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5571 | mg/kg bw/day | rat | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5652 | mg/kg bw/day | rat | oral | 45 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5673 | mg/kg bw/day | rat | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5691 | mg/kg bw/day | rat | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5863 | mg/kg bw/day | rat | oral | 49 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 6922 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7072 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7078 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7222 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7983 | mg/kg bw/day | rat | oral | 49 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 8251 | mg/kg bw/day | rat | oral | 45 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 10000 | mg/kg bw/day | rat | oral | 90 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 | ADI | =9 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2016 - OutputID 2799 - Consumers - Safety of the proposed extension of use of acesulfame K (E 950) in foods for special medical purposes in young children - doi:10.2903/j.efsa.2016.4437 |
| EFSA | ADI | =9 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2016 - OutputID 2799 - Consumers - Safety of the proposed extension of use of acesulfame K (E 950) in foods for special medical purposes in young children - doi:10.2903/j.efsa.2016.4437 |
NTP ICE acute oral 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | =5438 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | OECD eChemPortal (undated); record_id=acute_oral_7620; row=2856; data_type=In Vivo; mixture=Chemical; chemical_name=Acesulfame potassium; preferred_name=Acesulfame potassium; dtxsid=DTXSID1030606; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1030606; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1030606; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =5565 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | OECD eChemPortal (undated); record_id=acute_oral_7622; row=2857; data_type=In Vivo; mixture=Chemical; chemical_name=Acesulfame potassium; preferred_name=Acesulfame potassium; dtxsid=DTXSID1030606; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1030606; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1030606; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =7431 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_7624; row=2858; data_type=In Vivo; mixture=Chemical; chemical_name=Acesulfame potassium; preferred_name=Acesulfame potassium; dtxsid=DTXSID1030606; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1030606; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1030606; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =10175 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_7626; row=2859; data_type=In Vivo; mixture=Chemical; chemical_name=Acesulfame potassium; preferred_name=Acesulfame potassium; dtxsid=DTXSID1030606; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1030606; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1030606; 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=4514; RecordID=ARPathway2016_1323; DatasetName=ARPathway2016; DTXSID=DTXSID1030606; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1030606; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1030606 |
ECHA 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | NOAEL | >600 | mg/kg bw/day | Dog | oral | chronic; 2 years | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae66e4b0a7c65d1c91d7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/6/2?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID:15838778: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_c3ae8a1004e1021d2ee5708f506cd114 |
| ECHA | NOAEL | >1850 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b404c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/8?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817536_15817537: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_8a903246536bcf6e9c5b9334f5629cb2 |
| ECHA | NOAEL | >2340 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b404e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/8?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818154_15818155: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_a392378c1f8c02bd998c015ce2cc8605 |
| ECHA | NOAEL | >=2880 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae66e4b0a7c65d1c91c7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/6/2?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=organ weight and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID:15835561: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_d5c90175b2f4565a908fa2b62bfd6003 |
| ECHA | NOAEL | >5550 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b404a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/8?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817512_15818887: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_8a2b692ff9c5b54099262db3d66ef3ff |
| ECHA | NOAEL | =10000 | ppm | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c905e4b0a7c65d21b360; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/9/2?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855797_15856552_15857710:M/F:P0-; 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_80b52c1d87ca01dd696ed6b687275a6f |
| ECHA | NOAEL | >30000 | ppm | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1ebe4b0a7c65d230ade; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/9/3?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID:15822671:F:-maternal; 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_0d4972800555133fc52fbbd307966af7 |
| ECHA | NOEL | =900 | mg/kg bw/day | Rabbit | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be123; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10775/7/9/3?documentUUID=a7b614df-2815-4aa2-a3c4-8a75a38ff98b; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=ECHA IUCLID:15821793:M/F:-fetal; 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_4d9b51be4ea8beca098c954e223cf157 |
ToxValDB ECOTOX 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB ECOTOX | NOEL | =2000 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; 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=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15600714:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=107438ee723ed1dc78fd280e360519e4 |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =450 | 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:15633446:-:--; 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_b059912dfa7fe6f8dffc7fbf6c2eaacc |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 23OV73Q5G9 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4NO4S.K","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23OV73Q5G9"} |
| openFDA substances | FDA UNII substance identifier | 23OV73Q5G9 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4NO4S.K","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23OV73Q5G9"} |
| openFDA substances | FDA UNII substance identifier | 23OV73Q5G9 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4NO4S.K","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23OV73Q5G9"} |
| openFDA substances | FDA UNII substance identifier | 23OV73Q5G9 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4NO4S.K","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23OV73Q5G9"} |