Final report of the safety assessment of Acacia catechu gum, Acacia concinna fruit extract, Acacia dealbata leaf extract, Acacia dealbata leaf wax, Acacia decurrens extract, Acacia farnesiana extract, Acacia farnesiana flower wax, Acacia farnesiana gum, Acacia senegal extract, Acacia senegal gum, and Acacia senegal gum extract

摘要

These ingredients are derived from various species of the acacia plant. Only material derived from Acacia senegal are in current use according to industry data. The concentration at which these ingredients are reported to be used ranges from 9% in mascara to 0.0001% in tonics, dressings, and other hair-grooming aids. Gum arabic is a technical name for Acacia Senegal Gum. Gum arabic is comprised of various sugars and glucuronic acid residues in a long chain of galactosyl units with branched oligosaccharides. Gum arabic is generally recognized as safe as a direct food additive. Little information is available to characterize the extracts of other Acacia plant parts or material from other species. Acacia Concinna Fruit Extract was generally described as containing saponins, alkaloids, and malic acid with parabens and potassium sorbate added as preservatives. Cosmetic ingredient functions have been reported for Acacia Decurrens Extract (astringent; skin-conditioning agent--occlusive) and Acacia Farnesiana Extract (astringent), but not for the other Acacias included in this review. Toxicity data on gum arabic indicates little or no acute, short-term, or subchronic toxicity. Gum arabic is negative in several genotoxicity assays, is not a reproductive or developmental toxin, and is not carcinogenic when given intraperitoneally or orally. Clinical testing indicated some evidence of skin sensitization with gum arabic. The extensive safety test data on gum arabic supports the safety of Acacia Senegal Gum and Acacia Senegal Gum Extract, and it was concluded that these two ingredients are safe as used in cosmetic formulations. It was not possible, however, to relate the data on gum arabic to the crude Acacias and their extracts from species other than Acacia senegal. Therefore, the available data were considered insufficient to support the safety of Acacia Catechu Gum, Acacia Concinna Fruit Extract, Acacia Dealbata Leaf Extract, Acacia Dealbata Leaf Wax, Acacia Decurrens Extract, Acacia Farnesiana Extract, Acacia Farnesiana Flower Wax, Acacia Farnesiana Gum, and Acacia Senegal Extract in cosmetic products. The additional data needed to complete the safety assessment for these ingredients include (1) concentration of use; (2) identify the specific chemical constituents, and clarify the relationship between crude Acacias and their extracts and the Acacias and their extracts that are used as cosmetic ingredients; (3) data on contaminants, particularly relating to the presence of pesticide residues, and a determination of whether Acacia melanoxylon is used in cosmetics and whether acamelin (a quinone) and melacacidin (a flavin) are present in the Acacias that are being used; (4) skin sensitization study (i.e., dose response to be determined); (5) contact urticaria study at use concentration; and (6) ultraviolet (UV) absorption spectrum; if there is significant absorbance in the UVA or UVB range, then a photosensitization study may be needed. It was also noted that other data may be needed after clarification of the chemical constituents of the Acacia-derived ingredients.