Copper(2+) neodecanoate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with copper (2+) neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual assessment entities copper and neodecanoic acid. Copper (2+) neodecanoic acid is not expected to be mutagenic in bacteria, since the two moieties copper and neodecanoic acid have not shown gene mutation potential in bacteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No genetic toxicity study with copper (2+) neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual moieties copper and neodecanoic acid.

 

Copper

In vitro gene mutation

In a GLP study Ballantyne (1994) evaluated the mutagenic potential of Cu²⁺as copper sulphate pentahydrate in bacterial reverse mutation assay according to OECD guideline no. 471. The substance was tested at five different concentrations up to 800-1000 µg/plate at cytotoxic levels. Five different Salmonella typhimurium strains (TA98, TA100, TA1535, TA1537, and TA102) were tested both in presence and in absence of a metabolic activation system. No evidence for mutagenic activity in the strains tested was found.

 

Under normal physiological conditions, the concentration of free copper is extremely low in vivo and the majority of the copper is bound to ceruplasmin and albumin (See Section 5.1). In addition, cells contain high concentrations of potent antioxidants (e.g. glutathione). Therefore, the biological relevance of any in vitro observations would be uncertain where high concentration of the free ion would be available in cell culture growth medium. From reviews of public domain data (WHO, 1998; VRAR, 2008), there is conflicting evidence regarding the activity of copper in cell based assays for genotoxicity, however, due to the relevance of such studies in determining the genotoxicity potential of copper it is considered not appropriate or applicable to use these studies for copper and copper compounds.

Therefore it was considered more appropriate to review the genotoxic potential of copper and copper compounds using in vivo studies.

From the results above, copper sulphate pentahydrate, copper and other copper compounds are not considered genotoxic.

Neodecanoic acid

In vitro gene mutation

Neodecanoic acid is not mutagenic in vitro in bacterial mutation assays (with and without metabolic activation). This data suggests that neodecanoic acid is not genotoxic in vitro.

 

Copper (2+) neodecanoic acid

Copper (2+) neodecanoic acid is not expected to be mutagenic in bacteria, since the assessment entities copper and neodecanoic acid have not shown gene mutation potential in bacteria. Further testing is not required. For further information on the toxicity of the individual moieties addressed, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

Copper (2+) neodecanoate is not expected to be mutagenic in bacteria, since the two assessment entities copper and neodecanoic acid do show gene mutation potential in bacteria. Due to the lack of data, specifically for in vitro clastogenicity in mammalian cells, no decision can be made with regard to classification as germ cell mutagen.