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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Data source

Reference
Title:
Prediction of Gene mutation for copper di-d-gluconate study.
Year:
2018
Bibliographic source:
QSAR Toolbox 3.4.0.17
Report date:
2018

Materials and methods

Test guideline
Guideline:
other: REACH Guidance on QSAR R.6

Test material

Constituent 1
Chemical structure
Reference substance name:
Copper di-D-gluconate
EC Number:
208-408-2
EC Name:
Copper di-D-gluconate
Cas Number:
527-09-3
Molecular formula:
C12H22CuO14
IUPAC Name:
copper(2+) bis(2,3,4,5,6-pentahydroxyhexanoate)
Test material form:
solid
Specific details on test material used for the study:
SMILES: OCC{P-}(O)C{P-}(O)C{P+}(O)C{P-}(O)C(=O)O{-}.[Cu]{+}

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: not specified
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
True negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
Ames test result (with metabolic activation S9): Negative. No mutagenic potential