Nickel(III) oxy hydroxide

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2008-2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Objective of study:

other: Leaching of nickel substances in syntethic biological fluids (termed bioaccessibility).

Test guideline

Qualifier:

no guideline available

Deviations:

not applicable

Principles of method if other than guideline:

In situations where the bioavailability of a metal substance is not known or not feasible to determine experimentally, the amount of ion “available for absorption” may be measured using in vitro methods. In this application the dissolution (e.g., elution or extraction) of metal ion from surrogate (synthetic) tissue fluids is measured. The resultant value is termed bioaccessibility and is defined as the amount of a substance (e.g., metal ion) available for absorption. This report measured bioaccessibility of nickel substances as a surrogate for bioavailability.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Various nickel substances and metallic nickel were tested.

IUPAC Name:

Various nickel substances and metallic nickel were tested.

Details on test material:

Details for the test materials are provided in the attached report.

Radiolabelling:

no

Test animals

Species:

other: not applicable

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

Not applicable

Administration / exposure

Route of administration:

other: not applicable

Vehicle:

other: not applicable

Details on exposure:

Not applicable

Duration and frequency of treatment / exposure:

Not applicable

Doses / concentrations

Remarks:

Doses / Concentrations:
Not applicable

No. of animals per sex per dose / concentration:

Not applicable

Control animals:

other: not applicable

Positive control reference chemical:

Not applicable

Details on study design:

The samples were extracted in leaching fluids. The samples were extracted for four time periods (2, 5, 24, 72 hrs). The extractions were performed using 0.1 gram of sample in 50 ml of fluid. A shaker water bath at a temperature of 37C was used. All extractions were performed in duplicate. Blank fluids were extracted in duplicate at one time period. The extracts were analyzed for soluble nickel using ICP/MS. Results were reported as ug Ni/g sample and as % of total available Ni released.

Details on dosing and sampling:

Not applicable

Statistics:

Not applicable

Results and discussion

Preliminary studies:

Not applicable

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Not applicable

Details on distribution in tissues:

Not applicable

Details on excretion:

Not applicable

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

Not applicable

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: Data have been incorporated into read-across assessments for nickel and nickel-containing substances.