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Propyl Gallate

* A preservative * Please read TIA's post on What Is It: Preservatives and Parabens and Are They Safe?

Propyl Gallate is an antioxidant preservative used in a wide variety of cosmetics and beauty care products, including lipsticks, bath products, skin cleansing products, moisturizers, skin care products, makeup products, self-tanning products, and sunscreen and suntan products. It is an "ester formed by the condensation of gallic acid and propanol," according to Wikipedia, and is added to food and skin care products containing oils and fats to prevent oxidation. If oxidation occurs, it can result in rancidity, color changes, viscosity changes and deterioration of active ingredients in formulas, negating their effectiveness (CosmeticsInfo.org).

* A preservative

* Please read TIA's post on What Is It: Preservatives and Parabens and Are They Safe?

Functions:

Propyl Gallate is an antioxidant preservative used in a wide variety of cosmetics and beauty care products, including lipsticks, bath products, skin cleansing products, moisturizers, skin care products, makeup products, self-tanning products, and sunscreen and suntan products. It is an "ester formed by the condensation of gallic acid and propanol," according to Wikipedia, and is added to food and skin care products containing oils and fats to prevent oxidation. If oxidation occurs, it can result in rancidity, color changes, viscosity changes and deterioration of active ingredients in formulas, negating their effectiveness (CosmeticsInfo.org).

Propyl Gallate is on the FDA's list of ingredients that are Generally Recognized As Safe (GRAS) for use, but it is limited to a maximum concentration of 0.02% of the fat or oil content of the food. The CIR has approved Propyl Gallate as a safe ingredient in cosmetics and personal care products at concentrations less than or equal to 0.1%.

It has been found that Propyl Gallate, when included in oral products, "showed preventive effects, including a reduction in cancer, birth defects and cavities of the teeth. These positive effects were consistent with the ability of Propyl Gallate to scavenge free radicals," according to studies done by the CIR Safety Review and found on CosmeticsInfo.org.

Safety Measures/Side Effects:

However. Propyl Gallate is considered a controversial ingredient because of its links to cancer and other harmful side effects. The Cosmetics Database finds it to be a moderate hazard ingredient and notes concerns regarding cancer, developmental and reproductive toxicity, allergies and immunotoxicity, and lesser concerns of irritation. There is strong evidence that it is a human toxicant, although the EU classifies it with “Limited evidence of immune system toxicity.” Regarding endocrine, developmental and reproductive toxicity, studies showed that there were effects when Propyl Gallate was administered at high doses unlike those found in skin care formulas.

According to Wikipedia, recent studies found that Propyl Gallate can mimic estrogen similar to other xenoestrogens, potentially resulting in male organisms developing female traits, therefore increasing the risk of developing cancer in estrogen-sensitive tissues such as ovary, breast, prostate, etc. However, a study found on the website for the National Institutes of Health entitled “Carcinogenesis Bioassay of Propyl Gallate” focusing on 100 rats and 100 mice, 50 treated with Propyl Gallate and 50 untreated, for 103 weeks stated that "Under the conditions of this bioassay, propyl gallate was not considered carcinogenic for F344/N rats, although there was evidence of an increased proportion of low-dose male rats with preputial gland tumors, islet-cell tumors of the pancreas, and pheochromocytomas of the adrenal glands; rare tumors of the brain occurred in two low-dose females. Propyl gallate was not considered to be carcinogenic for B6C3F1 mice of either sex, although the increased incidence of malignant lymphoma in male mice may have been related to the dietary administration of propyl gallate."

The “Final report on the amended safety assessment of Propyl Gallate,” published in the International Journal of Toxicology, also found that Propyl Gallate was non-toxic when applied dermally. It found it to be non-irritating at concentrations up to 10% either. However, it is thought to be a sensitizer at concentrations as low as 1%. The assessment concluded that "Therefore, the Panel believes that a concentration limitation of 0.1% in cosmetics is necessary (given the evidence of sensitization at concentrations less than 1%) and sufficient (given that current products are not producing adverse reactions)."

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