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.

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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 91 mg/kg bw/day dog oral 1 year Chronic PAFA
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 296 mg/kg bw/day dog oral 365 day Chronic 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 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 1000 mg/kg bw/day monkey oral 28 day Neurotoxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
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 2500 mg/kg bw/day rat oral 28 day Short Term Toxicity 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 3000 mg/kg bw/day rat oral 56 day Short Term Toxicity 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 5000 mg/kg bw/day rat oral 56 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA 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
ECHA 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA 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
ECHA 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
ECHA 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
ECHA 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
ECHA 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
ECHA 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
ECHA 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
ECHA 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
WHO/JECFA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA 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 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 96K6UQ3ZD4 UNII - - - chemical -