Assessment of dermal absorption of aluminium from a representative antiperspirant formulation using a (26Al)Al microtracer approach: a follow-up study in humans

Author:

de Ligt Rianne1ORCID,Westerhout Joost2,Grossouw Dimitri1,Buters Thomas P3,Rissmann Robert3,Burggraaf Jacobus3,Windhorst Albert D4,Tozer Sarah5,Pappa Gerlinde6,Wall Brian7,Bury Dagmar8,Mason David R9,Vaes Wouter H J1

Affiliation:

1. TNO , P.O. Box 2215, 2301CE Leiden , The Netherlands

2. TNO , P.O. Box 80015, 3508TA Utrecht , The Netherlands

3. Center for Human Drug Research , 2333CL Leiden , The Netherlands

4. Department of Radiology and Nuclear Medicine , Free University Medical Center, P.O. Box 7057, 1007MB, Amsterdam , The Netherlands

5. Procter & Gamble Technical Centres Ltd , Reading RG2 0QE , UK

6. Beiersdorf AG , Unnastrasse 48, 20245 Hamburg , Germany

7. Colgate Palmolive Company , 909 River Road, Piscataway, NJ 08855 , USA

8. L’Oréal Research & Innovation , 9 rue Pierre Dreyfus, 92110 Clichy , France

9. Safety and Environmental Assurance Centre , Unilever, Colworth Science Park, Sharnbrook MK44 1LQ , UK

Abstract

Abstract A follow-up study was performed in 12 healthy women to evaluate systemic exposure to aluminium following topical application of a representative antiperspirant formulation under real-life use conditions (part A) and to assess the local fate of topically applied aluminium by taking additional tape strips and skin biopsies (Part B). A simple roll-on formulation, containing the maximal possible radioactive dose, was prepared with [26Al] aluminium-labeled chlorohydrate (ACH). The microtracer of [26Al] was used to distinguish aluminium from the natural background, using accelerator mass spectrometry. [26Al] aluminiumcitrate was administered intravenously to estimate the dermal fraction absorbed. Despite the 25-fold increase of the topical dose compared with the previous study, only 12 blood samples gave results above the lower limit of quantitation (0.118 fg/mL). The most reliable estimates of the dermal fraction absorbed are derived from noncompartmental analysis with the urine data. By using the intravenous dose to normalize the urinary excretion to 100% bioavailability, the best estimate of the fraction absorbed of [26Al] from a topical application of [26Al]-aluminium-labeled chlorohydrate in an antiperspirant formulation was 0.00052%. Part B of the study demonstrated that the majority of the aluminium in the formulation remained associated with the external layers of the skin without penetration through the skin.

Funder

Cosmetics Europe

Publisher

Oxford University Press (OUP)

Subject

Health, Toxicology and Mutagenesis,Toxicology

Reference22 articles.

1. Antiperspirants and the hyperhidrosis patient;Draelos;Dermatol Ther,2002

2. Double-blind, vehicle-controlled randomized twelve-month neurodevelopmental toxicity study of common aluminum salts in the rat;Neuroscience,2011

3. Safety of aluminium from dietary intake;European Food Standards Agency;EFSA J,2008

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