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J Cosmet Sci. 2009 Jul-Aug;60(4):405-14.

Determination of total lead in lipstick: development and validation of a microwave-assisted digestion, inductively coupled plasma-mass spectrometric method.

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  • 1Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD 20740, USA.


Recent reports describing the presence of lead (Pb) in lipsticks have suggested that, under ordinary use, the potential amount of Pb exposure is harmful. To permit independent assessment of the Pb contamination, a method for determining total Pb in lipstick using microwave-assisted digestion and analysis employing inductively coupled plasma-mass spectrometry (ICP-MS) was developed and validated. Since lipsticks may contain fats, oils, pigments, dyes, and minerals, several reference materials (RM) were analyzed, including coal, wear metals in oil, organic Pb in oil, milk powder, and estuarine sediment. With the exception of the RM with mineral content (estuarine sediment), complete recovery of Pb from the RMs was obtained by simple nitric acid (HNO(3)) digestion. Complete recovery of Pb from estuarine sediment was achieved only when hydrofluoric acid (HF) was added to the digestion mix, followed by treatment with excess boric acid (H(3)BO(3)) to neutralize the HF and to dissolve insoluble fluorides. Commercial lipsticks were tested for total Pb by the validated method. The detection limit was estimated to be 0.04 microg Pb/g. The average value obtained for the lipsticks was 1.07 microg/g. Undigested material was present in some lipstick digests when only HNO(3) was used, and generally lower Pb values were obtained. All of the Pb levels found by the U.S. Food and Drug Administration (FDA) were within the range the agency would expect to find in lipsticks formulated with permitted color additives and other ingredients prepared under good manufacturing practice (GMP) conditions. This method will be useful for the FDA and industry in helping to ensure the safety of cosmetic products.

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