Registration Dossier
Registration Dossier
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EC number: 839-353-8 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Bio-elution
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
- Objective of study:
- bioaccessibility (or bioavailability)
- Principles of method if other than guideline:
- Bio-elution refers to the in vitro extraction methods used to assess the bio-accessibility of a substance. This technique quantifies the degree to which a substance (e.g. metal mixtures) is released in artificial biological fluids of defined
composition and pH: interstitial, alveolar, lysosomal, synovial, gastric and intestinal juice.
Test material
- Reference substance name:
- Nickel Cobalt Manganese Hydroxide
- EC Number:
- 839-353-8
- Cas Number:
- 189139-63-7
- Molecular formula:
- Molecular formula: Ni1-x-yMnxCoy(OH)2, Stoechiometry of (Me = Ni + Co + Mn) equals 1, ranges of the elements approx. as: Ni/Me = 0.25 – 0.95 Mn/Me = 0.02 – 0.40 Co/Me = 0.02 – 0.40 OH = 2.00
- IUPAC Name:
- Nickel Cobalt Manganese Hydroxide
- Reference substance name:
- Manganese dihydroxide
- Cas Number:
- 18933-05-6
- Molecular formula:
- Mn(OH)2
- IUPAC Name:
- Manganese dihydroxide
- Reference substance name:
- Cobalt dihydroxide
- EC Number:
- 244-166-4
- EC Name:
- Cobalt dihydroxide
- Cas Number:
- 21041-93-0
- Molecular formula:
- CoH2O2
- IUPAC Name:
- cobalt(2+) dihydroxide
- Reference substance name:
- Nickel dihydroxide
- EC Number:
- 235-008-5
- EC Name:
- Nickel dihydroxide
- Cas Number:
- 12054-48-7
- Molecular formula:
- H2NiO2
- IUPAC Name:
- nickel(2+) dihydroxide
- Test material form:
- solid: particulate/powder
1
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Batch PVX-089 PVX14
Nickel Manganese Cobalt ratio 8:1:1
Results and discussion
Any other information on results incl. tables
The bio-accessible fraction was calculated based on the comparison of the metal release (see Results) with the metal bulk concentration of the compound (see Table 2). For the gastric bio-elution test, 13% of the metals released. The coefficient of variance (CV) between the three replicas was around 4% for the three metals, indicating a high reproducibility of the analytical results. For the lysosomal bio-elution test, a high reproducibility of the analytical results was noticed as well. The metal release of Co, Ni and Mn were found to be around 100%, i.e. all metals are fully bio-accessible in lysosomal fluid. In the alveolar bio-elution test, the release of Co, Mn and Ni were negligible.
In the case of Nickel Cobalt Manganese Hydroxide (8:1:1), Co, Mn and Ni are completely bio-accessible in the lysosomal synthetic fluids, while these metals are only partially bio-accessible in gastric fluid and not bio-accessible in alveolar synthetic fluid.
Applicant's summary and conclusion
- Conclusions:
- A bio-elution study to estimate the metal release of Nickel Cobalt Manganese Hydroxide (8:1:1) in three artificial solutions were performed.
The results show a similar release for Co, Mn and Ni (i.e. bio-accessible fraction) from Nickel Cobalt Manganese Hydroxide (8:1:1) in the three tested media. 13% of the metal was released in gastric fluid and around 100% in intracellular (lysosomal) fluid. No significant release in alveolar medium was measured. - Executive summary:
A bio-elution study to estimate the metal release of Nickel Cobalt Manganese Hydroxide (8:1:1) in three artificial solutions were performed.
The results show a similar release for Co, Mn and Ni (i.e. bio-accessible fraction) from Nickel Cobalt Manganese Hydroxide (8:1:1) in the three tested media. 13% of the metal was released in gastric fluid and around 100% in intracellular (lysosomal) fluid. No significant release in alveolar medium was measured.
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