Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
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 LOAEL in rat oral for copper di-d-gluconate
Year:
2018
Bibliographic source:
Modelo QSAR 180404 LOAEL Gluconato
Report date:
2018

Materials and methods

Test guideline
Guideline:
other: REACH Guidance on QSARs 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

Effect levels

Key result
Dose descriptor:
LOAEL
Effect level:
94.7 mg/kg bw/day (nominal)
Based on:
not specified
Basis for effect level:
other: not specified

Target system / organ toxicity

Key result
Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
LOAEL= 94.7 mg/kg bw/day. According to this value and the table 3.9.3. of the CLP Regulation, classification STOT RE-2 is applicable.