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	2592	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	2226	mg/kg bw/day	rat	oral	28 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	2707	mg/kg bw/day	rat	oral	95 day	Subchronic	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	5000	mg/kg bw/day	rat	oral	84 day	Short Term Toxicity	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	375	mg/kg bw/day	dog	oral	84 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
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	4690	mg/kg bw/day	rat	oral	NA	Reproductive	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	2400	mg/kg bw/day	monkey	oral	364 day	Chronic	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	5800	mg/kg bw/day	mouse	oral	28 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	10000	mg/kg bw/day	monkey	oral	15 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	150	mg/kg bw/day	dog	oral	90 day	Subchronic	PAFA; FAP

EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	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_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	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_OpenFoodTox_EFSA_ReferenceValues.xlsx	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

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

ToxValDB_EFSA 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_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

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	H5KI1C3YTV	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C40H62O19","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H5KI1C3YTV"}
openFDA substances	FDA UNII substance identifier	H5KI1C3YTV	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C40H62O19","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H5KI1C3YTV"}
openFDA substances	FDA UNII substance identifier	H5KI1C3YTV	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C40H62O19","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H5KI1C3YTV"}
openFDA substances	FDA UNII substance identifier	H5KI1C3YTV	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C40H62O19","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H5KI1C3YTV"}