NOAEL Studies Cosmetic Ingredient

Sucrose Acetate Isobutyrate NOAEL Studies

INCI: SUCROSE ACETATE ISOBUTYRATE

CAS: 126-13-6

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 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 450 mg/kg bw/day dog oral 90 day Subchronic PAFA; FAP
COSMOS DB LOAEL 500 mg/kg bw/day rat oral 365 day Chronic PAFA; FAP
COSMOS DB NOAEL 150 mg/kg bw/day dog oral 90 day Subchronic PAFA; FAP
COSMOS DB NOAEL 190 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 375 mg/kg bw/day dog oral 84 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 450 mg/kg bw/day dog oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1200 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1290 mg/kg bw/day dog oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2000 mg/kg bw/day rat oral 364 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2226 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2247 mg/kg bw/day rat oral 56 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2400 mg/kg bw/day monkey oral 364 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2500 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2592 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2707 mg/kg bw/day rat oral 95 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 4690 mg/kg bw/day rat oral NA Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral 84 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5300 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5800 mg/kg bw/day mouse oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 10000 mg/kg bw/day monkey oral 15 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =2000 mg/kg bw/day Rat oral: feed 364 days chronic/long term toxicity EFSA ANS - 2016 - OutputID 2817 - no adverse effect observed at single/highest dose - Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive - doi:10.2903/j.efsa.2016.4489
EFSA ADI =20 mg/kg bw/day Consumers - - ADI EFSA ANS - 2016 - OutputID 2817 - Consumers - Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive - doi:10.2903/j.efsa.2016.4489
EFSA NOAEL =2000 mg/kg bw/day Rat oral chronic; 52 weeks chronic LONG_REF=EFSA ANS (2016). Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive. doi:10.2903/j.efsa.2016.4489.; TITLE=Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2016.4489; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15624533: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_956008e2fbde2ca08d546d8be44b6bb8
NTP ICE acute oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 >5000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_2627; row=5883; data_type=In Vivo; mixture=Chemical; chemical_name=Sucrose, diacetate hexaisobutyrate; preferred_name=Saccharose acetate isobutyrate; dtxsid=DTXSID3027035; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3027035; source_file=acute_oral.xlsx
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier H5KI1C3YTV UNII - - - chemical -