2023-03-28 12:14:13
Two substances that can cause allergies and irritation in many professionals
2-Hydroxypropyl methacrylate (HPMA) and 2-hydroxyethyl methacrylate (HEMA) are used in many products such as adhesives, cosmetics or personal care products. Their irritant and sensitizing properties, particularly for the respiratory tract, have been evaluated by ANSES with the aim of proposing a harmonized classification at European level.
Although the HPMA substance is not currently subject to any harmonized classification within the framework of the CLP regulation, HEMA methacrylate is currently classified for its irritating properties for the skin and eyes and its ability to cause skin allergies.
Numerous scientific publications also identify methacrylates as agents responsible for occupational asthma. More particularly, the examination of vigilance data from Finnish occupational pathologies made it possible to identify respiratory hypersensitivity reactions observed in workers exposed to HEMA and HPMA methacrylates.
The identification of methacrylates as respiratory irritants is furthermore based on the fact that:
other methacrylates are classified for this property and they metabolize into methacrylic acid, a substance classified for its corrosive properties; the toxicokinetic and physicochemical data of HEMA and HMPA indicate that these two substances are able to reach the respiratory tract and to give rise to the release of methacrylic acid
Finally, regarding HPMA, the skin sensitizing properties of the substance are observed in numerous epidemiological studies and an in vivo study in rabbits caused severe eye irritation.
For all these reasons, ANSES therefore proposes that HEMA and HPMA methacrylates are classified and labeled as follows under the CLP regulation :
“Causes skin irritation; category 2 (H315)”, only for HEMA based on its current classification “Causes severe eye irritation; category 2 (H319) »« May cause a skin allergy; category 1 (H317) »« May cause allergic or asthma symptoms or breathing difficulties if inhaled; category 1 (H334) »« May irritate the respiratory tract; category 3 (H335) »
Harmonized classification proposals put out for public consultation
The harmonized classification proposals for HEMA and HMPA were made available for public consultation on the ECHA website on 13 March 2023 for a period of two months, to allow all stakeholders to comment or provide input. the scientific arguments and additional information available to them. Comments can be submitted via a dedicated form on the ECHA website.
Following this consultation stage, ANSES will be responsible for responding to the comments received. The initial proposal, the comments and the responses provided by ANSES will be brought to the attention of the ECHA Risk Assessment Committee, which will then issue an opinion concerning the classification of HEMA and HPMA.
On the basis of this opinion, the European Commission will then develop the regulatory texts to include the proposed classifications in the CLP regulation.
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