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Human systemic exposure to [14C]-paraphenylenediamine-containing oxidative hair dyes: Absorption, kinetics, metabolism, excretion and safety assessment

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Author: Nohynek, G.J. · Skare, J.A. · Meuling, W.J.A. · Wehmeyer, K.R. · Bie, A.T.H.J. de · Vaes, W.H.J. · Dufour, E.K. · Fautz, R. · Steiling, W. · Bramante, M. · Toutain, H.
Source:Food and Chemical Toxicology, 81, 71-80
Identifier: 525598
doi: doi:10.1016/j.fct.2015.04.003
Keywords: Biology · Consumer exposure · Hair dyes · Margin of safety · Paraphenylenediamine · TK-based safety assessment · Toxicokinetics · Carbon phenylenediamine c 14 · Hair dye · Phenylenediamine · Unclassified drug · Absorption · Adult · Blood analysis · Chemical reaction kinetics · Controlled study · Female · High performance liquid chromatography · Human · Human experiment · Male · Mass spectrometry · Metabolism · Population exposure · Radioactivity · Risk assessment · Skin test · Urinalysis · Urinary excretion · Rattus · Biomedical Innovation · Healthy Living · Life Triskelion BV · MSB - Microbiology and Systems Biology TARA - Toxicology and Risk Assessment · ELSS - Earth, Life and Social Sciences


Systemic exposure was measured in humans after hair dyeing with oxidative hair dyes containing 2.0% (A) or 1.0% (B) [14C]-p-phenylenediamine (PPD). Hair was dyed, rinsed, dried, clipped and shaved; blood and urine samples were collected for 48 hours after application. [14C] was measured in all materials, rinsing water, hair, plasma, urine and skin strips. Plasma and urine were also analysed by HLPC/MS/MS for PPD and its metabolites (B). Total mean recovery of radioactivity was 94.30% (A) or 96.21% (B). Mean plasma C<inf>max</inf> values were 132.6 or 97.4 ng [14C]-PPD<inf>eq</inf>/mL, mean AUC<inf>0-∞</inf> values 1415 or 966 ng [14C]-PPD<inf>eq</inf>/mL*hr in studies A or B, respectively. Urinary excretion of [14C] mainly occurred within 24 hrs after hair colouring with a total excretion of 0.72 or 0.88% of applied radioactivity in studies A or B, respectively. Only N,N'-diacetylated-PPD was detected in plasma and the urine. A TK-based human safety assessment estimated margins of safety of 23.3- or 65-fold relative to respective plasma AUC or C<inf>max</inf> values in rats at the NOAEL of a toxicity study. Overall, hair dyes containing PPD are unlikely to pose a health risk since they are used intermittently and systemic exposure is limited to the detoxified metabolite N,N'-diacetyl-PPD. © 2015 Elsevier Ltd.