Registration Dossier
Registration Dossier
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EC number: 233-071-3 | CAS number: 10028-18-9
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: Epidemiological data
- Adequacy of study:
- supporting study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Biochemical renal changes in workers exposed to soluble nickel compounds.
- Author:
- Vyskocil, A., V. Senft, C. Viau, M. Cizkova, and J. Kohout.
- Year:
- 1 994
- 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
- Qualifier:
- 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
- Reference substance name:
- soluble nickel compounds
- IUPAC Name:
- 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
Constituent 1
Method
- Type of population:
- occupational
- Subjects:
- - 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:
- inhalation
- Reason of exposure:
- unintentional, occupational
- Exposure assessment:
- measured
- 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.
- Examinations:
- - 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:
- URINE ANALYSIS:
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
- Conclusions:
- 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:
STUDY RATED BY AN INDEPENDENT REVIEWER.
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