Glycerin, Ethylene Glycol, Propylene Glycol and Diethylene Glycol

Holck, Harald G.O.

doi:10.1001/jama.1937.02780450021006

Cited by 28 publications

(2 citation statements)

References 2 publications

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“…Even as late as March 1937, Haag and Ambrose were reporting that the glycol was excreted substantially unchanged in dogs, suggesting that it was likely to be safe (Hagenbusch, 1937). Within a few weeks, Holick (1937) confirmed that a low concentration of diethylene in drinking water was fatal to a number of species. Hagenbusch (1937) found that the results of necropsies performed on patients who had been taking 60-70 ml of the solvent per day were similar to those of rats, rabbits, and dogs taking the same dose of solvent with or without the drug.…”

Section: Formulation Of Test Materialsmentioning

confidence: 86%

Formulations, Routes, and Dosage Design

Gad

2002

Drug Safety Evaluation

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Section: Formulation Of Test Materialsmentioning

confidence: 86%

Formulations, Routes, and Dosage Design

Gad

2002

Drug Safety Evaluation

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“…In a subchronic toxicity study, a group of six female rats was given a concentration of 3.58% propane-1,2-diol (equivalent to 2,890 mg/kg bw per day) via the drinking water for 11 weeks (Holck, 1937). During the experiment, one rat died (week 10).…”

Section: Ratsmentioning

confidence: 99%

Re‐evaluation of propane‐1,2‐diol (E 1520) as a food additive

Younes¹,

Aggett²,

Aguilar³

et al. 2018

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 propane-1,2-diol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propane-1,2-diol. Propane-1,2-diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane-1,2-diol is excreted in the urine. No treatment-related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2-year study in dogs. No adverse effects were reported in a 2-year chronic study in rats with propane-1,2-diol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane-1,2-diol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brand-loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane-1,2-diol (E 1520) at the reported use levels and analytical results.

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