Copper dibromide

Genetic toxicity: in vitro

Administrative data

Endpoint:

genetic toxicity in vitro, other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

EU RISK ASSESSMENT - [COPPER, COPPER II SULPHATE PENTAHYDRATE, COPPER(I)OXIDE, COPPER(II)OXIDE, DICOPPER CHLORIDE TRIHYDROXIDE] CAS [7440-50-8, 7758-99-8, 1317-39-1, 1317–38–0, 1332-65-6] CHAPTER 4.1.2. HUMAN HEALTH - EFFECTS ASSESSMENT

Author:

RAPPORTEUR: ITALY

Year:

2007

Bibliographic source:

European Copper Institute

Applicant's summary and conclusion

Conclusions:

Copper sulphate
Current classification for mutagenicity: none
The potential mutagenicity of copper sulphate has been investigated in a number of in vitro assays in bacterial and mammalian cells, and in several in vivo assays.
The overwhelming weight of evidence indicates that copper sulphate is negative in vitro in bacterial cell reverse mutation assays, and in several other bacterial cell assays up to and including cytotoxic doses (1000-~3000 μg/plate). Similar negative findings have also been reported for copper chloride.
Results from in vitro mammalian cell tests show that copper sulphate is genotoxic only at high, cytotoxic concentrations (up to 250 mg/l). This effect may be a result of copper-mediated generation of reactive oxygen species and/or inhibition of DNA-repair enzymes. Such concentrations of copper are irrelevant under normal conditions in vivo, where copper is generally bound to amino acid or protein ligands.
The most reliable in vivo data for copper sulphate come from two well-conducted, oral-dosing studies which were conducted according to Annex V guidelines and assigned the highest quality rating. In both of these studies, a micronucleus assay and a UDS test, copper sulphate was clearly negative. Results of these two studies provide no evidence that copper sulphate is mutagenic in vivo. Two other in vivo studies, both with a lower quality rating generated conflicting results, the basis of which remains uncertain, although strain variation has been suggested. Other in vivo studies deviated from Annex V methodology in such a way as to make the results unreliable.
Consideration of the weight of evidence from in vitro and in vivo tests, with greatest emphasis being placed on those in vivo tests which had the highest study rating, leads to the conclusion that copper sulphate is not mutagenic.
Consideration of the available in vitro and in vivo mutagenicity data for copper sulphate against EU classification criteria as contained in Annex VI of Directive 67/548/EEC results in the conclusion that there is no requirement for copper sulphate to be classified for mutagenicity.
Copper (I) oxide, copper (II) oxide, copper oxychloride, copper powder
Current classification for mutagenicity: none
No in vitro or in vivo mutagenicity data are available for these compounds.