Assessment of graphene-based materials against the Substances of Very High Concern criteria

Rapport, 2023

Recently, the nanomaterial carbon nanotubes was added to the Substitute It Now! (SIN) List managed by the International Chemical Secretariate (ChemSec). The SIN List considers the same hazard criteria for categorizing chemicals as so-called Substances of Very High Concern (SVHC) as the European chemical regulation REACH. In order to be considered as SVHC under REACH, a compound has to be identified as either: (i) carcinogenic; (ii) mutagenic; (iii) toxic to reproduction; (iv) persistent, bioaccumulative, and toxic; (v) very persistent and very bioaccumulative; or (vi) have properties that give rise to serious effects of an equivalent level of concern as points i-v. In this study, we evaluate another type of nanomaterial, namely graphene and other graphene-based materials (GBMs), and mirror current evidence of hazards and serious effects up against the SVHC criteria. The evaluation is based on a literature review of relevant studies identified in the scientific database Scopus (Elsevier B.V.) and previous review studies. The final corpus consisted of 30 studies that provided relevant information related to at least one of the SVHC criteria. No data was found on carcinogenicity, persistence, and endocrine disruption of GBMs. Studies on these criteria are therefore highly recommended. One study indicates that GBMs are not bioaccumulating, but more studies would be needed before a robust conclusion can be reached regarding this criterion. Several studies on toxicity were identified, with results clearly indicating that GBMs should not be classified as toxic. Several studies on reproductive toxicity, were also identified, of which some reported reproductive toxicity in mice. Finally, a number of studies observed genotoxic effects of GBMs, in some cases also explicit mutations. Although there are indications of reproductive toxicity and mutagenicity of GBMs, the current state of knowledge is limited. Detailed assessments of whether some or all GBMs should be classified as toxic to reproduction and mutagenic are therefore recommended. In conclusion, the current scientific evidence is not deemed strong enough to classify GBMs as SVHC, but the toxicological literature should be continuously be monitored, especially with regards to reproductive effects.