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Diss Factsheets

Administrative data

health surveillance data
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Long-term data on toxicokinetics for slags, ferronickel-manufg. is not available for the whole substance and is impossible to derive because of the nature of the substance. Being a UVCB, it consists of a number of different substances (mainly metals and metal oxides) that are bound together in a number of phases. Therefore it was attempted to identify possible adverse effects based on data for its recognised constituents, even though the results cannot be applied directly, due to the way the constituents are bound in the matrix of the substance and are not as bioavailable as the free substances that are examined (it is also supported by the low water solubility). So, the results must be taken into consideration with care.

Data source

Reference Type:
Nasal histology and nickel concentration in plasma and urine after improvements in the work environment at a nickel refinery in Norway
M. Boysen, L.A. Solberg, I. Andersen, A.C. Hogetveit, W. Torjussen
Bibliographic source:
Scand. j work environ health, vol.8, (1982), pp. 283-289

Materials and methods

Study type:
biological exposure monitoring
inhalation exposure
Endpoint addressed:
basic toxicokinetics
Test guideline
no guideline required
Principles of method if other than guideline:
A particular Test Guideline was not specified in the study.
GLP compliance:
Not needed for human study. Besides, the study was performed before the GLP criteria were developed.

Test material

Constituent 1
Reference substance name:
Nickel oxides and dust
Nickel oxides and dust
Details on test material:
Workers involved in the roasting/smelting process are mainly exposed to dry furnace dust of water-insoluble nickel subsulfide and oxide. In the electrolysis department workers are mainly exposed to water-soluble aerosols ofnickel sulfate and chloride. Nonprocess workers include plumbers, fitters, and electricians doing maintenance work in these two departments, as well as workers -employed in other departments of the plant. These
workers are exposed to various nickel compounds, but generally at lower concentrations and for shorter periods than the first two groups of workers


Type of population:
Ethical approval:
confirmed, but no further information available
Details on study design:
Population characteristics: Nickel refinery workers involved in roasting/smelting and electrolysing (n = 98) and 20 controls.
Exposure: Occupational exposure (inhalation route) was estimated from nickel measurements in the air. This was a follow-up study of a previous one, dating in 1976, when higher levels of Nickel were noted in the refinery. The average concentration of Nickel in the air was less than 0.1 mg/m3.
Serum and urine samples were taken for determination of Nickel concentrations by atomic absorption spectrophotometry.

Results and discussion

Main ADME parametres: No data
Details on absorption: Nickel levels in the plasma of the 98 nickel reexamined in 1979-1980 were significantly lower than the 1976 ones (p < 0.05), but they still exceeded those of referents
Details on distribution: No data
Details on excretion: Nickel levels in the urine of the 98 nickel reexamined in 1979-1980 were significantly lower than the 1976 ones (p < 0.05), but they still exceeded those of referents.

Reduction in the atmospheric content of Nickel and improved hygienic conditions lowered the concentration of nickel in the plasma and urine by approximately 50%. However, both plasma and urine levels were significantly higher than the control group.

Applicant's summary and conclusion

Plasma and urine samples of refinery workers and matched controls were examined for Ni levels. Ninety-eight (31 %) nickel workers who were part of a previous study were reexamined Reduction in the atmospheric content of nickel and improved hygienic conditions lowered the concentration of nickel in plasma and urine by approximately 50 %. However both plasma and urine levels were significantly higher than in the reference group