Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
study report

Materials and methods

Objective of study:
other: Leaching of nickel substances in syntethic biological fluids (termed bioaccessibility).
Test guideline
no guideline available
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:

Test material

Constituent 1
Reference substance name:
Various nickel substances and metallic nickel were tested.
Various nickel substances and metallic nickel were tested.
Details on test material:
Details for the test materials are provided in the attached report.

Test animals

other: not applicable
other: not applicable
Details on test animals or test system and environmental conditions:
Not applicable

Administration / exposure

Route of administration:
other: not applicable
other: not applicable
Details on exposure:
Not applicable
Duration and frequency of treatment / exposure:
Not applicable
Doses / concentrations
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
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

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