Resorcinol Could be Identified as an SVHC Under CLP Regulation Amendment

The European Commission is preparing an amending act proposing to introduce new hazard classes for endocrine disruptors in the CLP Regulation (EC No. 1272/2008). Within one year of the entry into force of the amending act, the EU Commission shall askEuropean Chemicals Agency (ECHA) to assess whether resorcinol meets the class of endocrine disruptors and whether it should be identified as a substance of very high concern (SVHC).

Background

In February 2020, France submitted a dossier to the ECHA for the identification of resorcinol (CAS No 108-46-3) as an SVHC because its endocrine-disrupting properties may have serious effects on human health.

In June 2020, a majority of members in the Member State Committee of the Agency (MSC) considered that resorcinol should be identified as an SVHC because of its thyroid-disrupting properties, which may cause serious effects on human health. However, the MSC did not reach a unanimous agreement. Eight members abstained from the vote and three members argued that there was not sufficient scientific evidence of probable serious effects to human health. Furthermore, two members that abstained from the vote made statements expressing concerns that in some studies the use of resorcinol did not lead to adverse effects and that the specific exposure conditions in the human case studies impeded a clear conclusion on whether resorcinol gives rise to an equivalent level of concern to those substances.

In July 2020, the Agency referred the MSC opinion to the EU Commission for a decision on the identification of resorcinol as an SVHC. The Commission notes, in line with the majority of the MSC members, that medical case reports provide evidence that the application of ointments containing high concentrations of resorcinol to ulcerated or undamaged skin over long periods led to hypothyroidism in patients, which was reversible upon cessation of exposure. Although most of these results were based on exposure via ulcerated skin, they are of high relevance for hazard identification in a regulatory context since they provide direct information that resorcinol results in serious adverse effects in humans.

The Commission considers that inconsistent findings in a two-generation reproductive toxicity study as well as the lack of effects seen in reliable animal studies with dermal exposure or with resorcinol administered via gavage, as referred to in the minority opinion, do not invalidate the available evidence on serious effects from other studies. Reliable in vivo studies with animals exposed via drinking water resulted in histopathological changes in the thyroid gland and in changes in circulating levels of thyroid hormones and thus provide evidence that resorcinol affects the regulation of the thyroid function inducing hypothyroidism in humans.

The Commission concurs with the majority of the MSC members that the biological plausibility between the evidenced thyroid mode of action of resorcinol and the observed adverse effects is strong and that resorcinol fulfills the World Health Organisation/International Programme on Chemical Safety (WHO/IPCS) definition of an endocrine disruptor.

About Resorcinol

Resorcinol (CAS No. 108-46-3), also called 1,3-Benzenediol, is an important fine petrochemical material. Resorcinol is prone to set off reactions such as hydrogenation, halogenation, ammoniation, acylation, coupling, alkylation, nitration, and sulphonation, which makes it possible to have extensive applications in fields including agriculture, dyes, coatings, medicine, plastics, and rubber.

As a basic organic chemical intermediate, resorcinol is widely used in the synthesis of pesticides and pharmaceuticals. For pharmaceutical uses, resorcinol has a bactericidal effect and can be used to manufacture intestinal disinfectants and dermatological drugs. For agricultural uses, it can be used to produce agricultural films, pesticides, herbicides, and so on. For dye uses, it can be used to synthesize fluorescent dyes, eosin, and hair dyes. In addition, resorcinol can also be used to produce formaldehyde resin and thermosetting wood adhesives.

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Reference

Commission Implementing Decision