Dioscorea Villosa (Wild Yam) Root Extract

The safety of Dioscorea Villosa (Wild Yam) Root Extract has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Dioscorea Villosa (Wild Yam) Root Extract was safe for use in cosmetics and personal care products.

CIR Safety Review: The CIR Expert Panel noted that Dioscorea Villosa (Wild Yam) Root Extract prepared via a specified process produced a stable extract with a narrow range of diosgenin content. The CIR Expert Panel was concerned about diosgenin because it can be used to make certain hormones. The extract produced using the specific methodology was tested in acute and short-term toxicity tests, dermal irritation tests, a sensitization test, an ocular irritation test, a test that looks at hormonal activity based on the weight of the uterus, and genotoxicity tests. An acute oral toxicity test produced hypoactivity, piloerection, and dyspnea at 2 g/kg using the specified extract, but no toxicity at 0.5 g/kg. A dermal toxicity test using the specified extract demonstrated no acute toxicity.

Both a 7-day local tolerance test and a 28-day dermal toxicity test produced no significant adverse effects at the maximum tested concentration of 10%. A single application of undiluted extract to the intact and abraded skin produced sufficient irritation for the test material to be rated “irritant,” but a 10% dilution was not irritating.

Undiluted extract was only mildly irritating to the conjuctiva of the eye; irritation in the iris and cornea was mild and transient. Undiluted extract was not irritating during the induction phase of a sensitization study, nor did challenge with a 25% dilution elicit any sensitization. The specified extract at doses up to 500 mg/kg/day did not have any hormonal activity in the assay that measured uterine weights. Genotoxicity assays in bacterial and other systems were negative. Extracts prepared as described in this safety assessment, with an upper limit of 3.5% diosgenin, did not have any hormonal activity, demonstrating that it is possible to produce material that does not present this specific safety concern. Based on these data, it was concluded that Dioscorea Villosa (Wild Yam) Root Extract was safe as used in cosmetic formulations.

More information about substances that may act like horomones.

Dioscorea Villosa (Wild Yam) Root Extract may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…