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Toxicological information

Repeated dose toxicity: oral

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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.