Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
developmental toxicity
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 NOAEL Teratogenicity in rat oral for copper di-d-gluconate
Year:
2018
Bibliographic source:
Modelo QSAR 180420 NOAEL Teratogenicity 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]{+}

Test animals

Species:
rat

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
not measured/tested

Maternal abnormalities

Key result
Abnormalities:
not examined

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
793 mg/kg bw/day (actual dose received)
Based on:
not specified
Basis for effect level:
other: not specified

Overall developmental toxicity

Key result
Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL= 793 mg/kg bw/day