Diethylene Glycol in Health Products Sold Over-the-Counter and Imported from Asian Countries

Abstract

Diethylene glycol (DEG), a chemical that has been implicated in multiple medication-associated mass poisonings, can result in renal and neurological toxicity if ingested. Three previous such mass poisonings implicated Chinese manufacturers as the origin of contaminated ingredients. No literature exists on potential DEG or triethylene glycol (TEG), a related compound, contamination of health products imported from Asian countries to the USA. Our primary objective was to quantitatively assess the amount of DEG present in a convenience sampling of these health products. The study's secondary objectives were to: (1) evaluate for, and quantify TEG levels in these samples; (2) compare DEG and TEG levels in these products directly to levels in medications implicated in previous similar mass poisonings; and (3) to estimate DEG dose (in mg/kg) based on the manufacturer's instructions and compare these values to toxic doses from past mass poisonings and the literature. A quantitative assessment of DEG and TEG was performed in a convenience sampling of over-the-counter health products imported from Asian countries. Results were converted to volume to volume (v/v) % and compared with DEG levels in medications implicated in previous mass poisonings. Estimated doses (based on the manufacturer's instructions) of each product with detectable levels of DEG for a 70 kg adult were compared to toxic doses of DEG reported in the literature. Seventeen of 85 (20%) samples were not able to be analyzed for DEG or TEG due to technical reasons. Fifteen of 68 (22%) samples successfully tested had detectable levels of DEG (mean, 18.8 μg/ml; range, 0.791-110.1 μg/ml; and volume to volume (v/v) range, 0.00007-0.01%). Two of 68 (3%) samples had TEG levels of 12.8 and 20.2 μg/ml or 0.0012% and 0.0018% TEG v/v. The product with the highest DEG% by v/v was 810 times less than the product involved in the Panama DEG mass poisoning (8.1%). The lowest reported toxic dose from a past DEG mass poisoning (14 mg/kg) was more than 150 times higher than the highest daily dose estimated in our study (0.09 mg/kg). Sixty-eight of 85 (80%) samples were able to be successfully analyzed for DEG and TEG. DEG and TEG were detectable in 15/68 (22%) and 2/68 (3%) samples, respectively. Based on current standards, these levels probably do not represent an acute public health threat. Additional research focusing on why DEG is found in these products and on the minimum amount of DEG needed to result in toxicity is needed.

Characterizing concentrations of diethylene glycol and suspected metabolites in human serum, urine, and cerebrospinal fluid samples from the Panama DEG mass poisoning

“…5,7,10 The few control samples that did have detectable serum DEG concentrations may have resulted from background environmental exposures as DEG can be found in packaging materials, cosmetics, and certain foodstuffs such as dietary supplements. 2,3 During the initial outbreak investigation in 2006, urinary DEG concentrations were determined by CDC on a small sample of case and control-patient specimens: a significant difference was found. 7 The reason for the difference in findings between the 2006 study and this one may be due to different samples being tested although the possibility that DEG underwent some degradation while in storage is possible.…”

“…1 It is found in trace, non-harmful amounts in other products such as some dietary supplements and cosmetics (probably as a manufacturing contaminant). 2,3 When ingested in large amounts (1–1.5 g/kg), DEG can be a potent nephrotoxic and neurological poison. 1,4 Unfortunately, DEG’s physical and chemical properties give it similar properties to solvents safely used in drug delivery such as propylene glycol and glycerin.…”

Etiloterapia en el servicio de urgencias. Una revisión de la literatura

“…En la mayoría de los casos, su consumo se da como consecuencia de un intento de suicidio, drogadicción, consumo de bebidas alcohólicas adulteradas o contaminación accidental. Se reconoce que son mal absorbidos por vía oral, por lo cual se requieren consumo relativamente importantes para que se produzca una intoxicación severa (48). La dosis tóxica del etilenglicol es de 1,5 ml/kg de peso y del dietilenglicol es de 0,17 mg/kg de peso.…”

Diethylene glycol-induced toxicities show marked threshold dose response in rats

“…In the Panama epidemic, the ingested dose to produce renal failure was estimated as 0.36 g/kg (Sosa et al, 2014). Therefore, estimates on the DEG dose associated with lethality in humans vary widely with the minimum value being 0.014 g/kg and the maximum being 1.8 g/kg (Schier et al, 2011). Such variability could result from the usual inter-human variability, but also from the normally poor quality of exposure data in acute human poisonings or from co-exposure to other substances in these poisonings.…”

“…Nevertheless, these studies suggest that the dose producing renal toxicity in humans is substantially less than the acute dose that produces renal toxicity in rats. For example, a dose of 2 g/kg in Wistar rats produces no toxicity, but would be considered a severely toxic and nearly lethal dose in humans (Besenhofer et al, 2010, 2011; Schier et al, 2011). …”