Proposal for classification of a compound found in clothing and responsible for skin allergies
A proposal for classification submitted by ANSES to the European Chemicals Agency (ECHA) under the CLP Regulation on product classification, labelling and packaging has been subject to public consultation since 24 August 2020. This proposal concerns acetophenone azine, a substance liable to cause skin allergies, which has been found in sport clothing. As part of this consultation, all stakeholders will be able to comment on the ANSES proposal or provide any additional information in their possession. ECHA’s Committee for Risk Assessment will then send its final opinion to the European Commission. If the substance is classified, the Commission will then decide on its inclusion in the CLP Regulation. If the proposal made by ANSES is accepted, this will have direct consequences on the labelling of mixtures containing this compound.
Skin allergies caused by substances found in textiles are a public health issue. Following cases of skin allergies or irritation resulting from the wearing of clothing or footwear, ANSES published an assessment report in 2018 on the chemicals found in these textiles that could cause the problems reported. During the course of these studies, ANSES identified a new compound, acetophenone azine, which is not yet classified under the European CLP Regulation (see box), informing users of its potential allergenic properties. Recent scientific publications have identified this compound as the cause of four severe cases of eczema in France, three in children and one in an adult. The chemical was found in sport clothing and equipment, including socks, shoes and shin pads. ANSES has studied its allergenic properties in greater detail in order to suggest a classification.
A series of tests to confirm the allergenic effect
The first stage involved using a modelling process to compare the structure of the compound with that of known allergens in order to find similarities. This showed that the skin sensitisation effects observed in clinical cases could be explained by the structure of the substance. ANSES then commissioned a number of tests, two on human cell cultures and one on mice. The compound's allergenic potential was confirmed by the two in vitro tests but not by the test on animals. Nevertheless, in view of the largely positive data, ANSES believes that the skin sensitisation properties of acetophenone azine justify its classification under the CLP Regulation.
The proposal for classification submitted for public consultation
Based on these findings, ANSES submitted a proposal for classification to the European Chemicals Agency (ECHA) in October 2019. If the proposal is accepted, acetophenone azine will be labelled as follows: “may cause an allergic skin reaction; Category 1 (H317)”.
This proposal was submitted for public consultation on the ECHA website on 24 August 2020, to give all stakeholders the opportunity to present their positions, scientific arguments or any additional information they have at their disposal. This public consultation will remain open for 60 days. Comments can be sent via a dedicated form on the ECHA website.
Following this consultation stage, ANSES will be asked to respond to the comments received. The initial proposal, comments and their responses will be placed before ECHA’s Committee for Risk Assessment, which will issue its opinion on the classification of acetophenone azine. On the basis of this opinion, the Commission will decide whether or not to include the harmonised classification in the CLP Regulation.
Regulation on Classification, Labelling and Packaging (CLP)
Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures, known as the CLP Regulation, is the legislation in force in the European Union to ensure the protection of workers, consumers and the environment. In particular, it aims to identify any hazards posed by a substance or substance mixture due to its physico-chemical properties and its effects on health and the environment. This regulation defines how these substances and mixtures must be classified, labelled and packaged. It also has impacts on other European regulations that could lead to the prohibition or substitution of highly hazardous substances or mixtures. Once the substance or mixture has been classified with regard to the identified hazards, appropriate labelling informs the user about these hazards through pictograms and safety data sheets. The European Chemicals Agency is responsible for its implementation.