Print Email Facebook Twitter Human systemic exposure to [14C]-paraphenylenediamine-containing oxidative hair dyes: Absorption, kinetics, metabolism, excretion and safety assessment Title Human systemic exposure to [14C]-paraphenylenediamine-containing oxidative hair dyes: Absorption, kinetics, metabolism, excretion and safety assessment Author Nohynek, G.J. Skare, J.A. Meuling, W.J.A. Wehmeyer, K.R. de Bie, A.T.H.J. Vaes, W.H.J. Dufour, E.K. Fautz, R. Steiling, W. Bramante, M. Toutain, H. Publication year 2015 Abstract 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 Cmax values were 132.6 or 97.4 ng [14C]-PPDeq/mL, mean AUC0-∞ values 1415 or 966 ng [14C]-PPDeq/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 Cmax 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. Subject Life Triskelion BVMSB - Microbiology and Systems Biology TARA - Toxicology and Risk AssessmentELSS - Earth, Life and Social SciencesBiomedical InnovationBiologyHealthy LivingConsumer exposureHair dyesMargin of safetyParaphenylenediamineTK-based safety assessmentToxicokineticsCarbon phenylenediamine c 14Hair dyePhenylenediamineUnclassified drugAbsorptionAdultBlood analysisChemical reaction kineticsControlled studyFemaleHigh performance liquid chromatographyHumanHuman experimentMaleMass spectrometryMetabolismPopulation exposureRadioactivityRisk assessmentSkin testUrinalysisUrinary excretionRattus To reference this document use: http://resolver.tudelft.nl/uuid:123d6916-4ef5-4c0c-b1a7-01144bb87de4 DOI https://doi.org/10.1016/j.fct.2015.04.003 TNO identifier 525598 ISSN 0278-6915 Source Food and Chemical Toxicology, 81, 71-80 Document type article Files To receive the publication files, please send an e-mail request to TNO Library.