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Butylene Glycol

Also known as: 1,3-Butylene Glycol, 1,2-Butylene Glycol, 1,3-Butanediol, 1,2-Butanediol, Butylene Glycol

Overview

Butylene Glycol is a synthetic organic compound primarily utilized in cosmetic and pharmaceutical formulations as a humectant, solvent, and skin-conditioning agent. It is a clear, colorless, and odorless liquid known for its good skin penetration and moisturizing properties when applied topically. While widely used in topical products, it is not typically derived from natural sources but is industrially synthesized. Its safety and metabolic effects have been investigated in animal models and some human trials, mainly concerning its use in cosmetics. Comprehensive systematic reviews or meta-analyses specifically addressing its use as an oral supplement ingredient are limited, with existing evidence primarily stemming from toxicological safety assessments and animal feeding studies. It serves as a carrier for active ingredients in various formulations.

Benefits

Butylene Glycol has shown some metabolic effects in animal studies, primarily influencing lipid metabolism. For instance, in rats, it has been observed to decrease plasma glucose and triglycerides, and reduce liver fatty acid synthesis. However, effects on triglycerides and glucose have varied in other animal models like pigs and chicks. While it acts as a humectant and improves skin hydration when applied topically, these benefits are not relevant to oral supplementation. No specific clinical benefits have been established in human populations for oral supplementation. Animal studies demonstrated statistically significant metabolic effects, such as reduced lipogenesis and plasma glucose, but these findings have not been translated into human clinical outcomes. Animal feeding trials, typically lasting 21 to 42 days, showed metabolic changes within these timeframes.

How it works

Butylene Glycol primarily influences lipid metabolism pathways, leading to a reduction in fatty acid synthesis in the liver and alterations in plasma lipid profiles in animal models. It affects carbohydrate and lipid metabolism, potentially through the modulation of enzymatic pathways involved in lipogenesis and glucose homeostasis. While specific molecular targets are not well-defined, its effects appear to be systemic on metabolic enzyme activities. Butylene Glycol is well absorbed after oral administration and is metabolized without accumulating in tissues. Its metabolites are either excreted unchanged or as glucuronides.

Side effects

Butylene Glycol is generally considered safe at concentrations typically used in cosmetics and in animal feeding studies. Toxicity studies in rats have shown no mortality at low doses, but adverse effects were observed at very high doses (e.g., ≥10% of the diet). At typical exposure levels, no common adverse effects have been reported. Uncommon side effects, observed at high doses in animal studies, include slightly reduced locomotor activity and increased kidney weights. Rare side effects have not been significantly documented. There are no documented drug interactions or established contraindications for typical cosmetic or dietary exposure. Data on its safety in special populations, such as pregnant or lactating women, are limited and not well-studied.

Dosage

The minimum effective dose for oral supplementation of Butylene Glycol has not been established in humans. Animal studies have utilized up to 20% dietary substitution without adverse effects on body weight. There are no human dosage guidelines for oral supplementation; animal studies have used doses up to 1000 mg/kg/day orally without severe toxicity. Toxicity has been observed only at very high doses, such as ≥10% of the diet or 22 g/kg/day in rats, which are far beyond typical exposure levels. In animal feeding studies, effects were observed after 21 to 42 days of administration. Butylene Glycol is primarily used in topical formulations, and data on oral supplementation are limited. It is well absorbed orally, and there is no evidence of tissue accumulation. No specific cofactors are identified as required for its action.

FAQs

Is Butylene Glycol safe for oral supplementation?

Animal studies suggest safety at moderate doses, but human data are lacking. It is primarily used topically in cosmetics and pharmaceuticals, not as an oral supplement.

Does it have metabolic benefits in humans?

No clinical trials in humans confirm metabolic benefits. Animal data suggest possible effects on lipid metabolism, but these have not been translated to human outcomes.

Can it cause toxicity?

Toxicity occurs only at very high doses in animals, far exceeding typical exposure levels. It is generally safe at concentrations used in cosmetics and low oral doses.

Is it absorbed and metabolized?

Yes, Butylene Glycol is well absorbed after oral administration and is metabolized by the body without accumulating in tissues. Metabolites are excreted.

Is it the same as Propylene Glycol?

No, while both are glycols with similar uses as solvents and humectants, they are distinct chemical compounds with slightly different safety profiles and applications.

Research Sources

https://journals.sagepub.com/doi/full/10.1177/1091581812460409 – This toxicological safety assessment, including animal studies, found no mortality at low doses of 1,2-glycols, including Butylene Glycol. High doses caused toxicity signs, but no tissue accumulation was observed, supporting its safety at cosmetic use levels. The study's limitations include reliance on animal data with limited human data.
https://journals.sagepub.com/doi/pdf/10.1177/1091581812460409 – This peer-reviewed toxicology journal article details a safety assessment of 1,2-Glycols. It concludes that these compounds, including Butylene Glycol, are safe for use in cosmetics based on animal studies showing no mortality at low doses and no tissue accumulation, despite toxicity at very high doses.
https://pubmed.ncbi.nlm.nih.gov/7322971/ – This controlled feeding trial in turkey poults demonstrated that Butylene Glycol reduced growth and lipogenesis. It also led to an increase in liver size but a decrease in liver lipid content, indicating its influence on avian metabolism. The study's limitation is that it is an animal model, and human data are not available.
https://cir-reports.cir-safety.org/view-attachment/?id=d28d9d62-8d74-ec11-8943-0022482f06a6 – This CIR report, a review of animal feeding studies, found that Butylene Glycol decreased fatty acid synthesis in rats and showed variable effects on plasma lipids. It noted no significant effect on body weight gain. The report's limitations include its reliance on animal data and the absence of human randomized controlled trials.
https://www.cir-safety.org/sites/default/files/dialkyl_acid_esters.pdf – This document from the CIR (Cosmetic Ingredient Review) provides a safety assessment that includes Butylene Glycol. It reviews various studies, primarily animal-based, to determine the safety of dialkyl acid esters in cosmetic products, concluding on their safety profile for topical applications.