Fate and disposition of sucrose-U-14C acetate isobutyrate in humans, rats, and dogs

Reynolds, R.C.; Astill, B. D.; Terhaar, C. J.; Fassett, David W.

doi:10.1021/jf60196a006

Cited by 8 publications

(11 citation statements)

References 3 publications

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“…The detected level in the carcass represents 6% of the applied dose and about 10% of the absorbed dose which was not eliminated. Similar results have been shown in additional experiments with 14 C‐sucrose (Reynolds et al., ). In comparison, rats fed pure 14 C‐sucrose incorporated about 11% of the applied dose.…”

Section: Assessmentsupporting

confidence: 89%

“…Studies on metabolic fate and elimination of SAIB were performed by Reynolds et al. () and Phillips et al. ().…”

Section: Assessmentmentioning

confidence: 99%

“…Reynolds et al. () measured the elimination of 14 C‐SAIB in all three species. Assuming no or low elimination via the bile, the absorption rate in rats was 71% at a dose of 11.2 mg/kg bw and 76% at 5.8 mg/kg bw (sum of excretion via exhaled air and urine plus radioactivity in carcass).…”

Section: Assessmentmentioning

confidence: 99%

“…At dose levels of 26 or 28 mg/kg bw, a similar absorption rate of approximately 70% is found (sum of radioactivity excreted via CO 2 and urine), although data on carcass radioactivity are missing. Lower absorption rates are suggested when 14 C‐SAIB was applied with higher dose levels (89 and 98 mg/kg bw) in corn oil: about 40% absorption at 89 or 98 mg/kg bw (sum of radioactivity excreted via CO 2 and urine) (Reynolds et al., ). Elimination data on rats presented by Phillips et al.…”

Section: Assessmentmentioning

confidence: 99%

“…In dogs, about 50% of the applied dose was eliminated in the faeces (at a dose of 3–5 mg/kg bw). However, at these dose levels, radioactivity was also excreted via the bile (in dogs 6% of applied dose of 4 mg/kg bw) (Reynolds et al., ) suggesting absorption rates slightly higher than 50%.…”

Section: Assessmentmentioning

confidence: 99%

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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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Section: Assessmentsupporting

confidence: 89%

“…Studies on metabolic fate and elimination of SAIB were performed by Reynolds et al. () and Phillips et al. ().…”

Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%