Quantitative risk assessment for skin sensitisation: Consideration of a simplified approach for hair dye ingredients

Goebel, Carsten; Diepgen, T.L.; Krasteva, Maya; Schlatter, Harald; Nicolas, Jean‐François; Blömeke, Brunhilde; Coenraads, Pieter Jan; Schnuch, Axel; Taylor, James S.; Pungier, J.; Fautz, Rolf; Fuchs, Anne; Schuh, W.; Gerberick, G. Frank; Kimber, Ian

doi:10.1016/j.yrtph.2012.10.004

Cited by 34 publications

(21 citation statements)

References 40 publications

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“…Thus, compared to hair dyeing, black henna tattoos appear to be a significant risk factor for PPD allergy (see Table 4) and for severe skin reactions to PPD (Krasteva et al, 2010). This finding is in line with quantitative assessment of the allergy induction threshold for PPD indicating that the high-exposure conditions for black henna tattooing clearly led to values exceeding the induction threshold, whereas maximal hair colorant use exposure to PPD was found to be close to the induction threshold (Goebel et al, 2012). Consequently, a single application of a black henna tattoo is more likely sufficient to induce contact allergy than hair coloring.…”

Section: Discussionsupporting

confidence: 71%

Prevalence of Contact Allergy to p-Phenylenediamine in the European General Population

Diepgen

Naldi

Bruze

et al. 2016

Journal of Investigative Dermatology

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Population-based studies on contact allergy to p-phenylenediamine (PPD) are scarce. A cross-sectional study was performed to assess the prevalence of contact allergy to PPD and its risk factors in the general population of 5 European countries. A total of 10,425 subjects were interviewed, and a random sample (n = 2,739) was patch tested to PPD. Overall, 5,286 individuals (50.9%) reported having used hair colorants at least once in their lifetime (78% female, 20% male), and 35% had used hair colorants during the last 12 months. Hair colorant avoidance because of any skin problem during the lifetime was reported by 6%. Black henna tattoos had been used by 5.5% during their lifetime. The prevalence of PPD contact allergy was 0.8% (95% confidence interval 0.6-1.0%), with no statistically significant association with gender or hair dye use. The prevalence of PPD in black henna tattoo users was 3.2% versus 0.6% in nonusers (P < 0.001). A clinically relevant positive patch test reaction to PPD related to hair coloring products was found in 0.1% (95% confidence interval 0.0-0.2%). A significant association with PPD contact allergy was observed for subjects who had black henna tattoos in their lifetime, with an age- and gender-adjusted odds ratio of 9.33 (95% confidence interval 3.45-25.26, P < 0.001). Black henna tattoos are an important risk factor for PPD contact allergy.

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Section: Discussionsupporting

confidence: 71%

Prevalence of Contact Allergy to p-Phenylenediamine in the European General Population

Diepgen

Naldi

Bruze

et al. 2016

Journal of Investigative Dermatology

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“…On the other hand there are chemicals that are tolerated by PPD‐sensitized patients. Elicitation responses to resorcinol, in line with its significantly lower sensitization potency in humans, are rarely found (0·1% in the above‐mentioned study), despite its presence in 80% of all hair dyes. Another benzene derivative – hydroxyethyl‐ p ‐phenylenediamine (HE‐PPD) sulfate – has less potential for cross‐reactivity.…”

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confidence: 97%

“…The latter study reported that 40 of 216 patients (18·5%) reacted to 1% PPD (free base in petrolatum) under diagnostic patch test conditions, whereas only five of them (2·3%) showed a positive reaction to a comparable amount of HE‐PPD sulfate (2%). Differences in the sensitizing potency between HE‐PPD sulfate and PPD or PTD are not likely to have a major impact on the rate of the elicitation response, as all three substances are considered as, at least, strong sensitizers.…”

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confidence: 99%

Cross-elicitation responses to 2-methoxymethyl-p-phenylenediamine under hair dye use conditions inp-phenylenediamine-allergic individuals

et al. 2015

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Under simulated hair dye use conditions, a significantly lower degree of cross-elicitation to ME-PPD (30%) was observed than previously reported for PPD (32 of 38, 84%). Additionally, a decreased cross-elicitation strength was observed across all three patch test grades, likely reflecting the reduced skin-sensitization properties of ME-PPD. Consequently, careful dermatological evaluation is required to assess cross-reactivity to ME-PPD in patients allergic to hair dyes.

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“…Animal tests have indicated that m-aminophenol, p-aminophenol, 1-naphthol and resorcinol are contact sensitizers, 1,5-10 being classified as strong contact sensitizers by the Scientific Committee on Consumer Safety. 11 However, whereas the precursor p-aminophenol and the coupler m-aminophenol frequently elicit patch test reactions in patch tested patients, with prevalences varying between 1.4% and 11%, [12][13][14] patch test reactions to 1-naphthol or resorcinol are rare, 1,10,15,16 although these couplers are also frequently used. Besides differences in exposure level and potential cross-reactivity patterns, differences in sensitization potency in humans may account for such different responses in patients.…”

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confidence: 99%

Ranking skin‐sensitizing hair dye molecules according to their potency by the use of human cells

Hennen

Blömeke

2018

Contact Dermatitis

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K E Y W O R D S : hair dye molecules, human skin sensitization potency, in vitro, quantitative risk assessmentThe determination of the skin sensitization potential (potency) of hair dye ingredients without animal testing is crucial for their quantitative risk assessment. Besides p-phenylenediamine (PPD) and toluene-2, 5-diamine (p-toluylenediamine [PTD]), which are 2 commonly used precursors and major allergens in oxidative hair dye-associated contact dermatitis, 1 >100 ingredients are currently used, including the precursor p-aminophenol. 2-4 p-Aminophenol is used together with couplers such as 1-naphthol, m-aminophenol or resorcinol to create different shades.Animal tests have indicated that m-aminophenol, p-aminophenol, 1-naphthol and resorcinol are contact sensitizers, 1,5-10 being classified as strong contact sensitizers by the Scientific Committee on Consumer Safety. 11 However, whereas the precursor p-aminophenol and the coupler m-aminophenol frequently elicit patch test reactions in patch tested patients, with prevalences varying between 1.4% and 11%, 12-14 patch test reactions to 1-naphthol or resorcinol are rare, 1,10,15,16 although these couplers are also frequently used. Besides differences in exposure level and potential cross-reactivity patterns, differences in sensitization potency in humans may account for such different responses in patients.We previously showed the capacity of our coculture model (COCAT) consisting of human cell lines, that is, HaCaT keratinocytes and THP-1 cells as surrogate dendritic cells, to rank PPD, PTD, and 2-methoxymethyl-p-phenylenediamine according to their potency based on the evaluation of the concentration inducing significant upregulation of the costimulatory molecule CD86 and/or adhesion molecule CD54 on cocultured THP-1 cells. 17 Here, we studied the sensitization potency of p-aminophenol, m-aminophenol, 1-naphthol and resorcinol in this model. METHODSTo assess the expression levels of CD86 and CD54 on cocultured THP-1 cells, THP-1 cells were exposed to p-aminophenol, m-aminophenol, 1-naphthol or resorcinol (Sigma Aldrich, Taufkirchen, Germany) in coculture with HaCaT cells for 24 hours. Expression of CD86 and CD54 on viable THP-1 cells (propidium iodide exclusion) was analysed with flow cytometry as described previously. 17-19 RESULTSAll chemicals upregulated CD86 and CD54 on cocultured THP-1 cells ( Figure 1). However, slightly different concentrations were needed for upregulation of CD86 and/or CD54, showing the potency in vitro (designated as ECΔ, estimated via linear interpolation). Low test concentrations were sufficient for p-aminophenol, whereas those for 1-naphthol, m-aminophenol and resorcinol slightly increased, in this order ( Figure 1).

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Quantitative risk assessment for skin sensitisation: Consideration of a simplified approach for hair dye ingredients

Cited by 34 publications

References 40 publications

Prevalence of Contact Allergy to p-Phenylenediamine in the European General Population

Prevalence of Contact Allergy to p-Phenylenediamine in the European General Population

Cross-elicitation responses to 2-methoxymethyl-p-phenylenediamine under hair dye use conditions inp-phenylenediamine-allergic individuals

Ranking skin‐sensitizing hair dye molecules according to their potency by the use of human cells

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