The safety of cosmetic ingredients HEMA and Di-HEMA Trimethylhexyl Dicarbamate - Submission I

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, L. Bodin, L. Celleno (Rapporteur), Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
Contact: SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1592/17
Adopted on: 21-22 June 2018

Conclusion of the opinion:

1. In light of the data provided, does the SCCS consider monomers of HEMA and Di-HEMA Trimethylhexyl Dicarbamate, safe at concentrations of up to 35% and 99% respectively when used in topically applied UV-cured artificial nail modelling systems?

The available evidence suggests that normal nail plate acts as a good barrier to penetration of chemical substances in general, and that both methacrylate monomers (HEMA and di-HEMA-TMHDC) polymerise rapidly under UV curing when applied as part of an artificial nail modelling system. This leaves very little chance for the monomers to be absorbed in any appreciable amount through the nail plate. In view of this, the SCCS is of the opinion that HEMA and di-HEMA-TMHDC, when applied appropriately to the nail plate at concentrations of up to 35% and 99% respectively as part of an artificial nail modelling system, are not likely to pose a risk of sensitisation, provided that their use is restricted to the nail plate only and contact with the adjacent skin is avoided.

2. Does the SCCS have any further scientific concerns with regard to the use of HEMA and Di-HEMA Trimethylhexyl Dicarbamate monomers in cosmetic products?

- More analytical data are needed to exclude the possibility of the presence of other sensitisers that may be present as impurities or degradation products alongside the two methacrylate monomers.

- Both HEMA and di-HEMA-TMHDC are weak to moderate sensitisers and pose a risk of sensitisation from misuse of the products or from inappropriately carried out application or from unintentional contamination of the skin adjacent to the nails under normal and reasonably foreseeable conditions of use.

- Filing or sanding nails to remove/replace previous applications may generate particle dust that may lead to respiratory exposure of the professionals if appropriate protective measures are not in place.

- The potential for sensitisation to the methacrylate monomers is likely to be higher amongst the professionals who carry out routine applications of artificial nail modelling systems without appropriate protective measures.

- In view of the growing popularity of artificial nail fashions and the potential use by consumers at home, and considering the observations of several professional dermatological organisations that the prevalence of contact dermatitis from artificial nail products (among which HEMA is an important constituent) is rising, a further increase of the prevalence of sensitisation is possible.

Keywords:

SCCS, scientific opinion, cosmetic ingredients, 2-hydroxyethyl methacrylate HEMA (CAS 868-77-9 and EC 212-782-2), Di-HEMA Trimethylhexyl Dicarbamate (CAS 41137-60-4 / 72869-86-4 and EC 276-957-5), SCCS/1592/17, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of cosmetic ingredients HEMA (CAS 868-77-9) and Di-HEMA Trimethylhexyl Dicarbamate (CAS 41137-60-4 / 72869-86-4) - Submission I (Sensitisation only), SCCS/1592/17, preliminary version adopted on 22 December 2017, final version adopted on 21-22 June 2018.