NOAEL Studies
Cosmetic Ingredient
Sucralose NOAEL Studies
INCI: SUCRALOSE
CAS: 56038-13-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 17 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 296 | mg/kg bw/day | dog | oral | 1 year | Chronic | PAFA |
| COSMOS_DB | NOAEL | 1500 | mg/kg bw/day | rat | oral | 21 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2000 | mg/kg bw/day | rat | oral | 89 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 4000 | mg/kg bw/day | rat | oral | 26 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 3000 | mg/kg bw/day | rat | oral | 56 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 700 | mg/kg bw/day | rabbit | oral | 14 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 750 | mg/kg bw/day | rabbit | oral | 14 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | rat | oral | 28 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2965 | mg/kg bw/day | mouse | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1000 | mg/kg bw/day | monkey | oral | 28 day | Neurotoxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2500 | mg/kg bw/day | rat | oral | 28 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 5000 | mg/kg bw/day | rat | oral | 56 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 296 | mg/kg bw/day | dog | oral | 365 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 119 | mg/kg bw/day | rat | oral | 14 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 150 | mg/kg bw/day | rat | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 233 | mg/kg bw/day | rat | oral | NA | Multigeneration Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 91 | mg/kg bw/day | dog | oral | 1 year | Chronic | PAFA |
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | <=15 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2016 - OutputID 2753 - Consumers - Safety of the proposed extension of use of sucralose (E 955) in foods for special medical purposes in young children - doi:10.2903/j.efsa.2016.4361 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | <=15 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2016 - OutputID 2753 - Consumers - Safety of the proposed extension of use of sucralose (E 955) in foods for special medical purposes in young children - doi:10.2903/j.efsa.2016.4361 |
ToxValDB_ECHA_IUCLID 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | >=30000 | ppm | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c905e4b0a7c65d21b392; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/9/2?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=P0: gross pathology; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=ECHA IUCLID:15855007: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_5fcc074440bc09d4018b355365ce18b9 |
| ToxValDB_ECHA_IUCLID | LOAEL | >=3000 | ppm | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c905e4b0a7c65d21b392; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/9/2?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15855906: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_1fafdb1ef03d43e5a68eaf63e5832170 |
| ToxValDB_ECHA_IUCLID | LOAEL | >=10000 | ppm | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c905e4b0a7c65d21b392; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/9/2?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=P1: body weight and weight gain|P1: food consumption and compound intake|P1: water consumption and compound intake|P1: organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|organ weight; STUDY_GROUP=ECHA IUCLID:15858159:M/F:P1-; 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_32efbdabae355613620c35bdce965469 |
| ToxValDB_ECHA_IUCLID | LOEL | ~750 | mg/kg bw/day | Rat | oral | chronic; 26 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae72e4b0a7c65d1c93d2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/6/2?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=body weight and weight gain|gross pathology|organ weights and organ / body weight ratios|water consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|gross pathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15840531_15847016_15847017: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_b2b559f952f541eacae80f57608c9a64 |
| ToxValDB_ECHA_IUCLID | NOAEL | >2340 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b4058; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/8?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15818074: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_8590ad9d4bd7798f267aea6a3870b2a4 |
| ToxValDB_ECHA_IUCLID | NOAEL | >1000 | mg/kg bw/day | Rabbit | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be14b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/9/3?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15821646:-:-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_268dcc5319eb4fdada5ef13fa0b13f84 |
| ToxValDB_ECHA_IUCLID | NOAEL | >3000 | mg/kg bw/day | Rat | oral | chronic; 26 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae72e4b0a7c65d1c93d2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/6/2?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=body weight and weight gain|gross pathology|organ weights and organ / body weight ratios|water consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|gross pathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15840531_15847016_15847017: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_9be9db55bcc0a63cfa5833093474afce |
| ToxValDB_ECHA_IUCLID | NOEL | =350 | mg/kg bw/day | Rabbit | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be14b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25256/7/9/3?documentUUID=335a64e4-b30e-4c55-be71-957174b87739; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: food consumption and compound intake|maternal: gross pathology|maternal: number of abortions; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|gross pathology|reproduction; STUDY_GROUP=ECHA IUCLID:15822940: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_390cdde9cf7280ca6d775831029f3fec |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =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_dup_EPA ORD_15604795_15604796:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9226ea0219ee7505190e7c2398c60de3 |
| ToxValDB_ECOTOX | NOEL | =1000 | 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_dup_EPA ORD_15604795_15604796:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=c89a1bf1b4d38284747c023c0c629c1c |
ToxValDB_WHO_JECFA_ADI 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_WHO_JECFA_ADI | ADI | <=15 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650af529e4b0d99f5a873609; 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/3107; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=WHO JECFA ADI:15715257:-:--; 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_7660a54e76c724155fc73e2290d32020 |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 96K6UQ3ZD4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H19Cl3O8","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"96K6UQ3ZD4"} |
| openFDA substances | FDA UNII substance identifier | 96K6UQ3ZD4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H19Cl3O8","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"96K6UQ3ZD4"} |
| openFDA substances | FDA UNII substance identifier | 96K6UQ3ZD4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H19Cl3O8","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"96K6UQ3ZD4"} |
| openFDA substances | FDA UNII substance identifier | 96K6UQ3ZD4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H19Cl3O8","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"96K6UQ3ZD4"} |