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Direct observations: clinical cases, poisoning incidents and other

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direct observations: clinical cases, poisoning incidents and other
Type of information:
other: Epidemiological data
Adequacy of study:
supporting study
Study period:
not reported
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions

Data source

Reference Type:
Biochemical renal changes in workers exposed to soluble nickel compounds.
Vyskocil, A., V. Senft, C. Viau, M. Cizkova, and J. Kohout.
Bibliographic source:
Human & Experimental Toxicology. 13(4):257-261.

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
repeated dose toxicity: inhalation
Test guideline
no guideline followed
Principles of method if other than guideline:
No standard guideline followed. Test methods described in the following sections.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
soluble nickel compounds
soluble nickel compounds
Details on test material:
- Name of test material (as cited in study report): Nickel sulphate (NiSO4)
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Substance type: NiSO4 and NiCl2 aerosols
- Other details not reported or not applicable


Type of population:
- Number of subjects exposed: 14 men and 12 women (12 male and 12 female age-matched controls)
- Sex: 14 men and 12 women
- Age: 26-64
- Race: not reported
- Demographic information: workers from a chemical plant
- Known diseases: not reported
- Other: 6 men and 4 women known smokers
- Other: exposure duration 25 yrs (ave. men) and 15 yrs (ave. women)
Ethical approval:
not specified
Route of exposure:
Reason of exposure:
unintentional, occupational
Exposure assessment:
Details on exposure:
Exposed to Ni aerosols. Airborne nickel concentrations measured at the end of shift and analyzed by AAS. In the chemical plant the workers were exposed to high concentrations of nickel which exceeded 4-26 times the threshold limit values (TLV) of 0.05 mg/m3.
- Urine analysis: measures include: total proteins, LDH, lysozyme, B2-m, albumin, NAG, RBP, and transferin.
Medical treatment:
none reported

Results and discussion

Clinical signs:
none reported
Results of examinations:
The concentration of nickel in the urine from male and female workers averaged 5.0 and 10.3 ug/g creatinine. No difference was found in the mean urinary excretion of lactate dehydrogenase, albumin and transferrin in both sexes, total proteins, b2-microglobulin (b2-m) and retinol-binding protein (RBP) in males and lysozyme in females. Lysozyme and N-acetyl-D-glucosaminidase (NAG) were elevated in male and total proteins, b2-m, NAG and RBP in female exposed workers. Significant correlation between urinary concentrations of nickel on one side and that of b2-m in women (r=0.462, p=0.022) and men (r=0.4, p=0.018) and of NAG in men (r=0.405, p=0.019) on the other side were found in exposed subjects. The results indicate adverse effects of soluble nickel compounds on the kidney tubular function.
Effectivity of medical treatment:
not applicable
Outcome of incidence:
not applicable

Applicant's summary and conclusion

The authors reported that adverse effects on the kidney tubular function of exposed workers were indicated, potentially resulting from high
occupational exposures to soluble nickel compounds.
Executive summary: