Cobalt Nickel Manganese Oxide

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:

2020

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

Test material information

impurity 1

Reference substance name:

Total unspecified impurities

IUPAC Name:

Total unspecified impurities

Constituent 1

Reference substance name:

Cobalt Nickel Manganese Oxide

Cas Number:

37348-84-8

Molecular formula:

Ni1-x-yMnxCoyOz with Me=Ni+Mn+Co=1 and Ni/Me= 0.45-0.98 Mn/Me= 0.01-0.35 Co/Me= 0.01-0.35 O/Me= 1.00-1.33

IUPAC Name:

Cobalt Nickel Manganese Oxide

Test material form:

solid

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 with the metal bulk concentration of the compound. For the gastric bio-elution test, Co, Ni and Mn have different releases: Mn was released for 6%, Co for 57% and Ni for 82%. The coefficient of variance (CV) between the three replicas was less than 2% 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 Oxide (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 Oxide (8:1:1) in three
artificial solutions was performed.
The results show different releases for Co, Mn and Ni from Nickel Cobalt Manganese Oxide (8:1:1)
for the gastric fluid. Mn was almost not released (only 6%), Co was 57% released and Ni have the
highest release of 82%. The intracellular (lysosomal) fluid show a similar release for CO, Mn and Ni
off 100%. No significant release in alveolar medium was measured.

Executive summary:

A bio-elution study to estimate the metal release of Nickel Cobalt Manganese Oxide (8:1:1) in three artificial solutions was performed.
The results show different releases for Co, Mn and Ni from Nickel Cobalt Manganese Oxide (8:1:1) for the gastric fluid. Mn was almost not released (only 6%), Co was 57% released and Ni have the highest release of 82%. The intracellular (lysosomal) fluid show a similar release for Co, Mn and Ni off 100%. No significant release in alveolar medium was measured.