Registration Dossier
Registration Dossier
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EC number: 948-085-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
For oral repeated dose toxicity the NOAEL value predicted was 750 mg/kg bw/day (actual dose received).
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: REACH Guidance on QSAR R6
- 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
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 839 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: QSAR predicted value
- Critical effects observed:
- not specified
- Organ:
- not specified
- Conclusions:
- The value obtained for the LOAEL of the prediction was 839 mg/kg bw/day (actual dose received)
- Endpoint:
- repeated dose toxicity: oral, other
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: REACH Guidance on QSAR R6
- 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
- Key result
- Dose descriptor:
- LOEL
- Effect level:
- 255 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: Not specified
- Remarks on result:
- other: QSAR predicted value
- Critical effects observed:
- not specified
- Organ:
- not specified
- Conclusions:
- The value obtained for the LOEL of the prediction was 255 mg/kg/day
- Endpoint:
- chronic toxicity: oral
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: REACH Guidance on QSAR R6
- 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
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: QSAR predicted value
- Critical effects observed:
- not specified
- Organ:
- not specified
- Conclusions:
- The value obtained for the NOAEL of the prediction was 750 mg/kg bw/day (actual dose received)
- Endpoint:
- repeated dose toxicity: oral, other
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: REACH Guidance on QSAR R6
- 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
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 20.9 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other:
- Remarks:
- QSAR predicted value
- Critical effects observed:
- not specified
- Organ:
- not specified
- Conclusions:
- The value obtained for the NOEL of the prediction was 20.9 mg/kg bw/day (nominal)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Species:
- rat
- Organ:
- not specified
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Although the physical state described on section 1.2 (composition) and 1.4 (Appearance/ physical state/ colour) for the substance Reaction mass of copper digluconate, sodium sulphate and copper sulphate is solid, the manufacturing method (described in section 3.5.1.) only allows substance synthetisation as a dissolution, containing at most a 50% of Reaction mass of copper digluconate, sodium sulphate and copper sulphate.
Therefore, studies for physical hazards determination, were developed using solid substance form, whereas for toxicology and ecotoxicology hazards, the dissolution (≤ 50% Reaction mass of copper digluconate, sodium sulphate and copper sulphate) form was used as stated on guidelines.
In consequence, the substance has been classified taking into account that it always will be in a dissolution in a maximum of 50% of concentration.
Justification for classification or non-classification
The NOAEL value predicted was < 100mg/kg bw/day. The substance does not clasified as STOT RE.
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