FINAL REPORT Safety Assessment of Malic Acid and Sodium Maiate A! Malic Acid functions in cosmetic formulations as a pH adjuster, and Sodium Malato functions as a skin

Malic Acid functions in cosmetic formulations as a pH adjuster, and Sodium Malato functions as a skin concfdioning agent humectant. Malic Acid is reportedly used in almost 50 cosmetic formulations across a range of producttypes, while Sodium Malate is used in only one. One commercial method of preparing Malic Acid is hydration of fumaric acid or malelc acid, and then purified to limit the amount of the sta~ng material present. Since Ma/ic Acid is a component ofthe Kreb's cycle, another method is fermentation. Mallc Acid was relatively nontoxic in acute toxicity studies using animals. In a chronic ore/study, feeding Malio Acid to rats resulted only in weight gain changes and changes in feed consumption. Malic Acid did not cause reproductive toxicity in mice, rats, or rabbits. Malic Acid was a moderate to strong skin Irritatant In animal tests, and was a strong ocular irritant. Malic Acid was not mutagenic across a range of genotoxlcity tests. Malic Acid was irritating in clinical tests, with less irritation seen as phi of the applied matertal increased. Patients patch tested with Malic Acid, placed on a diet that avoided foods containing Malic or citric acid, and then challenged with a diet high in Malic and citric acid had both immediate urticarial and delayed contact dermatitis reactions. These data were considered sufficient to determine that Malic Acid and Sodium Malate would be safe as used as pH adjusters. The data, however, were insutficient to determine the safety of these ingredients when used in cosmetics as other than pH adjusters and specifically, the data are insufficient to determine the safety of Sodium Malale when used as a skin conditioning agenthumectant. The types of data required for the Expert Panel to determine the safety of Sodium Malate as a skin conditioning agent are: concentration of use data; dermal irritation and sensitization data; and ocular irritation data, i f available. The data needed to assess the safety of Malic Acid or Sodium Malate for some function other than as a pH adjuster or skin conditioning agent cannot be specified without knowing the intended function. Were these ingredients to be used as exfoliants, for example, data similar to that included in the report on G/yco/ic and Lactic Acid (i.e., the Alpha Hydrexy Acid report) (CIR, 1997) would be needed. Until these data are available, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic formulations for functions other than use as a pH adjuster.