Stearamide DIBA-Stearate

The safety of Stearamide DIBA-Stearate 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 the available data were insufficient to assess the safety of Stearamide DIBA-Stearate as used in cosmetics and personal care products.

CIR Safety Review: The CIR Expert Panel noted that few data on this ingredient were available. However, data on related ingredients, including Dibutyl Adipate, Diisopropyl Adipate, Stearamide DEA and Stearamide MEA were considered in the assessment of safety. A formulation containing 1.3% Stearamide DIBA-Stearate (further diluted to 4% of the formulation) was mildly irritating but nonsensitizing in a repeated-insult patch test (RIPTRIPT stands for Repeat Insult Patch Test. In RIPT, a small amount of product is applied to the skin of each individual subject and monitored for its effect. Over a certain interval of time, the skin is observed, graded, and tested again.). The same dilution was noncomedogenic. Subchronic dermal exposure of Dibutyl Adipate (1.0 ml/kg/day) caused a reduction in weight gain that was not observed at a dose of 0.5 ml/kg/day. In other studies, undiluted Dibutyl Adipate caused mild to moderate skin irritation and minimal ocular irritation. Diisopropyl Adipate had low acute oral and percutaneous toxicity, and was only a very mild ocular irritant. In skin irritation studies, 5% to 100% Diisopropyl Adipate caused minimal to mild irritation; these results were also seen in clinical testing with only moderate cumulative irritation, and no sensitization or photosensitization. A formulation containing 5.27% Stearamide MEA was not toxic when applied topically daily for 13 weeks.

Studies using Stearamide DEA (35% to 40%) showed it was not a skin or ocular irritant, and Stearamide MEA (5.27%) was not an ocular irritant. At 17%, Stearamide MEA was not irritating to the skin, but caused minimal to moderate irritation to the eyes. Stearamide MEA (5.27%) did not cause sensitization during a clinical study. After review of all of the available data, the CIR Expert Panel noted that it was not possible to determine the relevance of these data to the evaluation of the safety of Stearamide DIBA-Stearate. Additional data requested by the CIR Expert Panel included impurities, genotoxicity data and UV absorption data. Stearamide DIBA-Stearate 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.. Ingredients of animal origin must comply with European Union animal by-products regulations.

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