Registration Dossier
Registration Dossier
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EC number: 269-093-5 | CAS number: 68187-40-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77364.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No genetic toxicity studies with Olivine, cobalt silicate blue are available, thus the genetic toxicity will be addressed with existing data on the relevant toxic unit cobalt. The source information is taken from the Cobalt REACH Consortium dossier for genetic toxicity in which all available information is given for in vitro and in vivo genetic toxicity. Further details are given in the source endpoint summary.
Additional information
The genetic toxicity of Olivine, cobalt silicate blue is addressed with existing data on the source substances identified in the read-across of the cobalt category substances as defined by the Cobalt REACH Consortium.
Based on the approach for the genetic toxicity for the cobalt category substances, the pigment Olivine, cobalt silicate blue is also a member of that category, thus unrestricted read-across to the CoRC data is made.
The relevant information is given in the source study records and are discussed in the source endpoint summary and are not repeated here for the sake of brevity.
Justification for classification or non-classification
The hazard conclusion for Olivine, cobalt silicate blue for the endpoint germ cell mutagenicity is adopted from the cobalt category substances, based on the read-across approach as outlined in the report attached to section 13.
Based on the entire database of genetic toxicity studies and the review by the OECD and an external peer reviewer it is concluded that in summary, poorly soluble cobalt salts/compounds do not appear to be genotoxic in vitro or in vivo at all, soluble cobalt salts do not elicit any mutagenic activity either in bacterial or mammalian test systems. However they induce some genotoxic effects in vitro, mainly manifest as DNA strand or chromosome breaks, which are consistent with a reactive oxygen mechanism, as has been proposed by various authors. A weight-of-evidence approach was applied, considering positive as well as negative in vivo clastogenicity studies and the absence of such chromosome damage in humans that are occupationally exposed to inorganic cobalt substances. It was concluded that effective protective processes exist in vivo to prevent genetic toxicity with relevance for humans from the soluble cobalt salts category (OECD 2014, Kirkland et al. 2015).
Based on the above information, the classification criteria for germ cell mutagenicity according to regulation (EC) 1272/2008 are not met, thus no classification required.
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