Evaluating 1,3-Propanediol for Potential Skin Effects

May 1, 2010 | Contact Author | By: Leigh A. Belcher, Carl F. Muska, PhD, and Joseph W. DeSalvo, DuPont
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Title: Evaluating 1,3-Propanediol for Potential Skin Effects
1x 3-propanediolx dermal irritationx dermal sensitizationx cosmetic ingredientx
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Keywords: 1 | 3-propanediol | dermal irritation | dermal sensitization | cosmetic ingredient

Abstract: In the present article, the authors assess the skin irritation and sensitization potential of 1,3-propanediol (INCI: Propanediol). Results in animals and humans by acute or repeat exposure support a low potential of skin reactivity for the material. In addition, the skin reactivity potential in humans was found to be lower with 1,3-propanediol than 1,2-propanediol (INCI: Propylene Glycol).

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LA Belcher, CF Muska and JW DeSalvo, Evaluating 1,3-propanediol for potential skin effects, Cosm & Toil 125(5) 81-86 (May 2010)

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Glycols have been used in cosmetics and personal care products to impart beneficial properties such as humectancy, solvency, moisturization and emulsification. One such ingredient is 1,3-propanediol (PDO), which is manufactured either by a chemical process using petroleum feedstock or by a fermentation (bio-based) process using corn sugar. Since PDO became commercially available only recently, it does not yet have a widespread history of use for properties such as humectancy, moisturization or emulsification. However, a substance structurally similar to PDO, propylene glycol (PG), does have widespread use and distribution in personal care products—but it also has a history of some dermal irritation and to a lesser extent, sensitization.

Obviously, besides the efficacy properties of a raw material, another critical property is the lack of or low potential for dermal irritation and sensitization of skin. Therefore, an evaluation of the potential for new ingredients to cause adverse skin reactions is essential. Information from previous animal studies following exposure to chemically-produced PDO suggests a low potential for human skin reactions. This historical information includes a study in rabbits (Draize method), showing neat PDO is mildly irritating; and a study in guinea pigs (Landsteiner/Draize method), showing no dermal irritation or sensitization.


Lab Practical: Using PDO

  • When replacing another glycol with PDO, substitute it 1:1 in the formulation.
  • If cloudiness or solubility issues arise, adjust the order of addition and mix PDO into the aqueous phase and/or increase the blending temperature.
  • When formulating solid deodorants, increase the blending temperature.
  • 60% maximum PDO is recommended for solid deodorant sticks with sodium stearate; if shrinkage occurs, a solubilizing agent is recommended.

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Table 1. Summary of skin reactions in the described 200-person RIPT

Table 1. Summary of skin reactions in the described 200-person RIPT

In the 200-person RIPT, no clinically significant skin reactions were observed for PDO. High and low pH did not impact the skin results even at 75% PDO. A few subjects exposed to 25%, 50% and 75% PDO did exhibit barely perceivable or mild redness (erythema) at 24 hr or 72 hr post-challenge, but the sites were considered clinically insignificant at the final observation.

Figure 1. PDO and PG structural depictions

Figure 1. PDO and PG structural depictions

A substance structurally similar to PDO, propylene glycol (PG), does have widespread use and distribution in personal care products—but it also has a history of some dermal irritation and to a lesser extent, sensitization.

Footnotes [Belcher 125(5)]

a Zemea Propanediol (INCI: Propanediol) is a product of DuPont Tate & Lyle Bio Products, LLC.

b Propylene Glycol (INCI: Propylene Glycol) was purchased from Sigma-Aldrich.

c The 100-subject RIPT was conducted by ConTox Ltd., Philadelphia, PA.

d The 200-subject RIPT was conducted by Consumer Product Testing Co., Fairfield, NJ.

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