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Hair Dye Allergy

SCCS/1509/13

A “Memorandum on hair dye substances and their sensitising properties” adopted during the 10th Plenary of the SCCP on 19 December 2006, summarised the evaluation on the 48 hair dye substances that had been assessed by the SCCP at that time. 27 of the dyes were noted to fulfil the EU criteria for classification as skin sensitizers (R43). Additionally, 10 of the 27 classifiable hair dye substances were categorised as extreme sensitizers, 13 as strong and 4 as moderate sensitizers.

The SCCP stated that hair dye substances which fulfil the criteria for classification as R43

may not be safe for consumers and that this is particularly so for hair dye substances

categorised as extreme and strong sensitizers.

It was necessary to write the Memorandum as the assessment of the safety of hair dyes has

been in terms of general toxicology rather than sensitization potential. Hence, “hair dye

chemical X is safe for use at Y% in hair dyes intended for the consumer apart from its

potential to cause skin sensitization”.

The response to the above Memorandum by the European Commission (29 March 07) was:

1. The Commission services will now extend their assessment in order to minimise

possible risks of allergic reactions caused by hair dyes.

2. Epidemiological studies are necessary to examine the extent of skin allergies to hair

dyes in the EU’s population.

3. Threshold values for sensitizers of high concern need to be determined to take

appropriate measure on a possible decrease of exposure.

An updated review of the sensitizing potency of the hair dye chemicals now evaluated by the

SCCS, the former SCCP and SCCNFP, is below (which should be considered as indicative, as

evaluations are ongoing). The SCCS confirms the views expressed in the earlier

Memorandum, that hair dye substances which fulfil the criteria for classification as R43 (now

Skin Sens 1 H317 according to CLP) may not be safe for consumers and that this is

particularly so for hair dye substances categorised as extreme and strong sensitizers.

Extreme 13

Strong 23

Moderate 20

Insufficient testing + Possibly sensitising 24 + 5

Not classifiable 29

Table 1. Hair dye substances assessed by the SCCS and the former SCCP and SCCNFP

concerning their skin sensitising property, based on submissions by industry. Results from

studies performed by OECD guideline methods (LLNA, GPMT and Buehler test). Typically,

results from one study per method are displayed. The substances fulfilling the criteria for

SCCS/1509/13

classification as skin sensitiser (R43, Skin Sens 1 H317 according to CLP) were categorised

according to their sensitising potency (Memorandum on hair dye substances and their skin

sensitising properties, SCCP 2006; Memorandum on classification and categorisation of skin

sensitisers and grading of test reactions, SCCP 2005). If data from more than one met

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