Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
25.02.2019
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 LOEL teratogenicity in rat oral for copper gluconate+copper sulphate+sodium sulphate
Year:
2019
Bibliographic source:
QSAR Toolbox 3.4.0.17
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSAR R6

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Remarks:
Bluish liquid
Specific details on test material used for the study:
SMILES:O=S(=O)(O{-}.[Na]{+})O{-}.[Na]{+}_O=S1(=O)O{-}.[Cu]{2+}.O{-}1_OCC{P-}(O)C{P-}(O)C{P+}(O)C{P-}(O)C(=O)O{-}.[Cu]{2+}.O{-}C(=O)C{P-}(O)C{P+}(O)C{P-}(O)C{P-}(O)CO

Test animals

Species:
rat

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Key result
Dose descriptor:
LOEC
Effect level:
2 660 mg/kg bw/day
Based on:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: QSAR predicted value

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
LOEL
Effect level:
2 660 mg/kg bw/day
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: QSAR predicted value

Overall developmental toxicity

Key result
Developmental effects observed:
not specified
Treatment related:
not specified

Applicant's summary and conclusion

Conclusions:
The value obtained for the LOEL teratogenicity of the prediction was 2660 mg/kg/day