4-Week Range-finding and 1-Year Oral Toxicity Studies of Sucrose Acetate Isobutyrate (SAIB) in the Cynomolgus Monkey

Blair, Martha L.; Chappel, C.I.

doi:10.1016/s0278-6915(97)80302-x

Cited by 8 publications

(2 citation statements)

References 13 publications

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“…Sucrose Acetate Isobutyrate was evaluated in monkeys in a 1-year study in which an NOAEL of 2.4 g/kg/d (the highest dosage rate tested) was reported. 56 Although statistically significant changes in hematological parameters were reported at the higher dosage rates (1.45-2.4 g/kg/d), overall the treatment was well-tolerated. Reported from a 1-year rat study testing Sucrose Acetate Isobutyrate was an NOAEL of 2 g/kg/d (highest dosage rate tested).…”

Section: Toxicological Studiesmentioning

confidence: 85%

Safety Assessment of Saccharide Esters as Used in Cosmetics

Scott¹,

Bergfeld²,

Belsito³

et al. 2021

Int J Toxicol

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This is a safety assessment of 40 saccharide ester ingredients as used in cosmetics. The saccharide esters are reported to function in cosmetics as emollients, skin-conditioning agents, fragrance ingredients, and emulsion stabilizers. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the relevant data for these ingredients. The Panel concluded that the saccharide esters are safe in cosmetics in the present practices of use and concentrations described in this safety assessment.

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Section: Toxicological Studiesmentioning

confidence: 85%

Safety Assessment of Saccharide Esters as Used in Cosmetics

Scott¹,

Bergfeld²,

Belsito³

et al. 2021

Int J Toxicol

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“…Uncertainties on the exposure assessment were identified and discussed. According to Reynolds and Chappel (1998), the mixture can contain all 256 possible esters, with the major components being sucrose (acetate) 2 (isobutyrate) 6 , while sucrose (acetate) 6 (isobutyrate) 2 can be present only in minor amounts.…”

Section: Methodologiesmentioning

confidence: 99%

Re‐evaluation of sucrose acetate isobutyrate (E 444) as a food additive

2016

EFS2

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The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sucrose acetate isobutyrate (SAIB, E 444) as a food additive. The SCF allocated an acceptable daily intake (ADI) of 10 mg/kg body weight (bw) per day in 1994. JECFA established an ADI of 20 mg/kg bw per day in 1997. Both the JECFA and the SCF concluded that the hepatic effects observed in the dog have little relevance to the safety evaluation in humans. The Panel agreed with this conclusion. Oral absorption is approximately 70% in rats, about 50% in dogs and ≥ 88% in humans. The Panel concluded that SAIB does not raise concern for genotoxicity. No treatment-related effects have been observed on clinical signs, haematology and clinical chemistry in humans at a dose of 20 mg/kg bw per day for 14 days. The Panel identified a no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day, the highest dose tested, from chronic toxicity, carcinogenicity and reproductive and developmental studies in rats. Applying an uncertainty factor of 100, an ADI of 20 mg/kg bw per day for SAIB can be established. Overall, the Panel concluded that the present data set on absorption, distribution, metabolism and excretion, genotoxicity, subchronic, developmental and long-term toxicity, and carcinogenicity give reason to revise the ADI of 10 mg/kg bw per day allocated by the SCF in 1994 to 20 mg/kg bw per day. Considering that the ADI is not exceeded in any population group, the Panel also concluded that the use of SAIB (E 444) as a food additive at the permitted or reported use and use levels would not be of safety concern.

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