Studies on absorption and metabolism of propylene glycol distearate

Long, Calvin L.; Domingues, M. Fátima; Studer, Vincent; Lowry, Jane; Zeitlin, B.R.; Baldwin, R. R.; Thiessen, R.

doi:10.1016/0003-9861(58)90090-0

Cited by 15 publications

(6 citation statements)

References 13 publications

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“…Long et al. () obtained similar results in an in vitro study using propane‐1,2‐diol distearate as the substrate. The hydrolysis rate was calculated by dividing the moles of free fatty acid analysed by the moles of the substrate initially available.…”

Section: Assessmentmentioning

confidence: 56%

“…At an initial concentration of 0.2 mM, this ester was shown to be hydrolysed by pancreatic lipase (addition of 'pancreas extracts', no further details) to the extent of 37% in 2 h and about 70% in 15 h at a temperature of 40°C (Balls and Matlock, 1938). Long et al (1958a) obtained similar results in an in vitro study using propane-1,2-diol distearate as the substrate. The hydrolysis rate was calculated by dividing the moles of free fatty acid analysed by the moles of the substrate initially available.…”

Section: In Vitro Studiesmentioning

confidence: 61%

“…Contrasting results were obtained in a further study in rats having received by gavage PDDS* (n = 2) or PD*DS (n = 1) (Long et al., ). In the two rats having received PDDS*, 65.8% of applied radioactivity was found in faeces, 17.5% in exhaled CO 2 , 6.4% in urine, 6.2% in organs and 10.8% in carcass; the total recovery was 106.8%.…”

Section: Assessmentmentioning

confidence: 72%

“…The biological disposition of 14 C‐labelled propane‐1,2‐diol ester of distearate after oral administration by gavage, was studied in male and female Wistar rats (Long et al., ,b).…”

Section: Assessmentmentioning

confidence: 99%

See 3 more Smart Citations

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Flavourings¹,

Younes²,

Aquilina³

et al. 2018

EFS2

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The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of propane-1,2-diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane-1,2-diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short-term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane-1,2-diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane-1,2-diol ester of fatty acids would be due to propane-1,2-diol, previously re-evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane-1,2-diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane-1,2-diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non-brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane-1,2-diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane-1,2-diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(12):5497 SummaryThe Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated propane-1,2-diol esters of fatty acids in 1974 and stated that there is evidence for hydrolysis of propane-1,2-diol esters of fatty acids resulting in the products propane-1,2-diol, for which an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day has previously established, and fatty acids. JECFA established an ADI of 25 mg/kg bw per day for propane-1,2-diol esters of fatty acids, this ADI was expressed as propane-1,2-dio...

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Section: Assessmentmentioning

confidence: 56%

Section: In Vitro Studiesmentioning

confidence: 61%

Section: Assessmentmentioning

confidence: 72%

“…The biological disposition of 14 C‐labelled propane‐1,2‐diol ester of distearate after oral administration by gavage, was studied in male and female Wistar rats (Long et al., ,b).…”

Section: Assessmentmentioning

confidence: 99%

See 2 more Smart Citations

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Flavourings¹,

Younes²,

Aquilina³

et al. 2018

EFS2

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“…(52) Approximately 6% of the total dose or 19% of the absorbed dose of PGDS* was excreted in the urine in 72 hours. Labeled stearic acid was 33% absorbed in 3 hours, while propylene glycol was absorbed at an even greater rate (94% in 5 hours).…”

Section: Absorption Metabolism Storage and Excretionmentioning

confidence: 99%

5 Final Report on the Safety Assessment of Propylene Glycol Stearate and Propylene Glycol Stearate Self-Emulsifying

Elder¹

1983

Journal of the American College of Toxicology

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Stearate Self-E m u lsifyi ng Propylene Glycol Stearates (PGS) are a mixture of the mono-and diesters of triple-pressed stearic acid and propylene glycol and are used in a wide variety of cosmetic products.Studies with 14C-fabeled PGS show that it is readily metabolized following ingestion. In rats, the acute oral LD50 has been shown to be approximately 25.8 g/kg. The raw ingredient produced no significant dermal toxicity, skin irritation, or eye irritation in acute tests with rabbits. Subchronic animal studies produced no evidence of oral or dermal toxicity. Propylene glycol monostearate was negative in in vitro microbial assays for mutagenicity.In clinical studies, PGS produced no significant skin irritation at concentrations up to 55% nor skin sensitization on formulations containing 2.5%. Photo-contact allergenicity tests on product formulations containing 1.5% PGS were negative.From the available information, it i s concluded that Propylene Glycol Stearates are safe as cosmetic ingredients in the present practices of use. CHEMISTRY CompositionPropylene Glycol Stearate ropylene Glycol Stearate (PGS) is a mixture of the 1,2-propanediol mono-P and diesters of stearic and palmitic acids in which the monoester, propylene glycol monostearate, predominates. It is produced by reacting propylene glycol and triple-pressed stearic acid under elevated temperatures in the presence of a catalyst. The general reaction is as follows:

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Emulgatoren und Emulsionsstabilisatoren in der Nahrung

Reith¹

1965

Z. Präventivmed

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Studies on absorption and metabolism of propylene glycol distearate

Cited by 15 publications

References 13 publications

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

5 Final Report on the Safety Assessment of Propylene Glycol Stearate and Propylene Glycol Stearate Self-Emulsifying

Emulgatoren und Emulsionsstabilisatoren in der Nahrung

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