Background: Metal impurities such as nickel and chrome are present in natural ingredients-containing cosmetic products. These traces are unavoidable due to the ubiquitous nature of these elements. Dead Sea mud is a popular natural ingredient of cosmetic products in which nickel and chrome residues are likely to occur.
Objective: To analyze the potential systemic and local toxicity of Dead Sea mud taking into consideration Dead Sea muds' natural content of nickel and chrome.
Methods: The following endpoints were evaluated: (Regulation No. 1223/20, 21/12/2009) systemic and (SCCS's Notes of Guidance) local toxicity of topical application of Dead Sea mud; health reports during the last five years of commercial marketing of Dead Sea mud.
Results and conclusions: Following exposure to Dead Sea mud, MoS (margin of safety) calculations for nickel and chrome indicate no toxicological concern for systemic toxicity. Skin sensitization is also not to be expected by exposure of normal healthy skin to Dead Sea mud. Topical application, however, is not recommended for already nickel-or chrome-sensitized persons. As risk assessment of impurities present in cosmetics may be a difficult exercise, the case of Dead Sea mud is taken here as an example of a natural material that may contain traces of unavoidable metals.
Keywords: 1223/2009/EC; CMR impurity; Chrome; Cosmetic regulation; Cosmetics; Dead Sea mud; Metal traces; Nickel; Risk assessment; Safety evaluation.
Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.