Evaluation of in vitro testing strategies for hazard assessment of the skin sensitization potential of “real-life” mixtures: The case of henna-based hair-colouring products containing p-phenylenediamine

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Evaluation of in vitro testing strategies for hazard assessment of the skin sensitization potential of “real-life” mixtures : The case of henna-based hair-colouring products containing p-phenylenediamine. / de Ávila, Renato Ivan; Veloso, Danillo F.M.C.; Teixeira, Gabriel C.; Rodrigues, Thaisângela L.; Lindberg, Tim; Lindstedt, Malin; Fonseca, Simone G.; Lima, Eliana M.; Valadares, Marize C.

I: Contact Dermatitis, Vol. 81, Nr. 3, 2019, s. 194-209.

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de Ávila, Renato Ivan ; Veloso, Danillo F.M.C. ; Teixeira, Gabriel C. ; Rodrigues, Thaisângela L. ; Lindberg, Tim ; Lindstedt, Malin ; Fonseca, Simone G. ; Lima, Eliana M. ; Valadares, Marize C. / Evaluation of in vitro testing strategies for hazard assessment of the skin sensitization potential of “real-life” mixtures : The case of henna-based hair-colouring products containing p-phenylenediamine. I: Contact Dermatitis. 2019 ; Vol. 81, Nr. 3. s. 194-209.

RIS

TY - JOUR

T1 - Evaluation of in vitro testing strategies for hazard assessment of the skin sensitization potential of “real-life” mixtures

T2 - The case of henna-based hair-colouring products containing p-phenylenediamine

AU - de Ávila, Renato Ivan

AU - Veloso, Danillo F.M.C.

AU - Teixeira, Gabriel C.

AU - Rodrigues, Thaisângela L.

AU - Lindberg, Tim

AU - Lindstedt, Malin

AU - Fonseca, Simone G.

AU - Lima, Eliana M.

AU - Valadares, Marize C.

PY - 2019

Y1 - 2019

N2 - Background: Allergic contact dermatitis caused by henna-based hair-colouring products has been associated with adulteration of henna with p-phenylenediamine (PPD). Objectives: To develop a testing approach based on in vitro techniques that address key events within the skin sensitization adverse outcome pathway in order to evaluate the allergenic potential of hair-colouring products. Methods: The following in vitro assays were used to test the sensitizing capacity of hair dye ingredients: the micro-direct peptide reactivity assay (mDPRA); the HaCaT keratinocyte-associated interleukin (IL)-18 assay; the U937 cell line activation test (U-SENS)/IL-8 levels; the blood monocyte-derived dendritic cell test; and genomic allergen rapid detection (GARD skin). Those techniques with better human concordance were selected to evaluate the allergenic potential of 10 hair-colouring products. Results: In contrast to the information on the label, chromatographic analyses identified PPD in all products. The main henna biomarker, lawsone, was not detected in one of the 10 products. Among the techniques evaluated by testing hair dye ingredients, the mDPRA, the IL-18 assay, GARD skin and the U-SENS correlated better with human classification (concordances of 91.7%-100%) and were superior to the animal testing (concordance of 78.5%). Thus, these assays were used to evaluate hair-colouring products, which were classified as skin sensitizers by the use of different two-of-three approaches. Conclusions: Our findings highlight the toxicological consequences of, and risks associated with, the undisclosed use of PPD in henna-based “natural” “real-life” products.

AB - Background: Allergic contact dermatitis caused by henna-based hair-colouring products has been associated with adulteration of henna with p-phenylenediamine (PPD). Objectives: To develop a testing approach based on in vitro techniques that address key events within the skin sensitization adverse outcome pathway in order to evaluate the allergenic potential of hair-colouring products. Methods: The following in vitro assays were used to test the sensitizing capacity of hair dye ingredients: the micro-direct peptide reactivity assay (mDPRA); the HaCaT keratinocyte-associated interleukin (IL)-18 assay; the U937 cell line activation test (U-SENS)/IL-8 levels; the blood monocyte-derived dendritic cell test; and genomic allergen rapid detection (GARD skin). Those techniques with better human concordance were selected to evaluate the allergenic potential of 10 hair-colouring products. Results: In contrast to the information on the label, chromatographic analyses identified PPD in all products. The main henna biomarker, lawsone, was not detected in one of the 10 products. Among the techniques evaluated by testing hair dye ingredients, the mDPRA, the IL-18 assay, GARD skin and the U-SENS correlated better with human classification (concordances of 91.7%-100%) and were superior to the animal testing (concordance of 78.5%). Thus, these assays were used to evaluate hair-colouring products, which were classified as skin sensitizers by the use of different two-of-three approaches. Conclusions: Our findings highlight the toxicological consequences of, and risks associated with, the undisclosed use of PPD in henna-based “natural” “real-life” products.

KW - allergic contact dermatitis

KW - alternative methods

KW - cosmetics

KW - hair dyes

KW - mixtures

KW - skin sensitization

U2 - 10.1111/cod.13294

DO - 10.1111/cod.13294

M3 - Article

C2 - 31006869

AN - SCOPUS:85067887170

VL - 81

SP - 194

EP - 209

JO - Contact Dermatitis

JF - Contact Dermatitis

SN - 0105-1873

IS - 3

ER -