Safety evaluation of traces of nickel and chrome in cosmetics: The case of Dead Sea mud.
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.


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.
AHAVA - Dead Sea Laboratories, Airport City Lod, 7015002, Israel; Dead Sea and Arava Science Center, The Laboratory for Skin Biochemistry and Biotechnology, Ein-Gedi 8698000, Israel.
Ze'evi
Z
Ma'or
Geological Survey of Israel, Jerusalem 9550166, Israel.
Ludwik
L
Halicz
AHAVA - Dead Sea Laboratories, Airport City Lod, 7015002, Israel; Dead Sea and Arava Science Center, The Laboratory for Skin Biochemistry and Biotechnology, Ein-Gedi 8698000, Israel. Electronic address: meital.p@ahava.com.
Meital
M
Portugal-Cohen
Angel Consulting SAS, Via San Senatore 14, Milano 20122, Italy.
Matteo Zanotti
MZ
Russo
Angel Consulting SAS, Via San Senatore 14, Milano 20122, Italy.
Federica
F
Robino
In vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090 Brussels, Belgium.
Tamara
T
Vanhaecke
In vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090 Brussels, Belgium.
Vera
V
Rogiers
D000818:Animals; D002857:Chromium / Q000009:adverse effects / Q000032:analysis*; D003257:Consumer Product Safety; D003358:Cosmetics / Q000009:adverse effects / Q000737:chemistry*; D019015:Geologic Sediments / Q000737:chemistry*; D006801:Humans; D009094:Mud Therapy / Q000009:adverse effects / Q000379:methods*; D009532:Nickel / Q000009:adverse effects / Q000032:analysis*; D019055:No-Observed-Adverse-Effect Level; D009792:Oceans and Seas; D018570:Risk Assessment; D018675:Toxicity Tests
D003358:Cosmetics; D002857:Chromium; D009532:Nickel
1223/2009/EC; CMR impurity; Chrome; Cosmetic regulation; Cosmetics; Dead Sea mud; Metal traces; Nickel; Risk assessment; Safety evaluation