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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Meets generally accepted scientific methods with sufficient documentation. Relevant exposure to submission substance, adequate detail on exposure and sampling methods. (A detailed description of the scoring criteria can be found in the .pdf document attached to the 'Exposure Scoring Rationale Document' record at the beginning of Section 7.10.5).
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
Reference Type:
publication
Title:
Exposure to soluble nickel in electrolytic nickel refining.
Author:
Kiilunen M, Utela J, Rantanen T, Norppa H, Tossavainen A, Koponen M, Paakkulainen H, Aitio A
Year:
1997
Bibliographic source:
Ann Occup Hyg 41: 167-188

Materials and methods

Type of study / information:
Nickel aerosol exposure information for a nickel refinery
Endpoint addressed:
not applicable
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No standard guideline followed. Details on test methods described in the following sections.
GLP compliance:
not specified

Test material

Specific details on test material used for the study:
The presence of soluble nickel accounts for 95% of total nickel exposure in the facility and insoluble nickel accounts for 4% of total nickel exposure in the facility (but about 11% in the leaching area).

Method

Ethical approval:
not applicable
Details on study design:
Thirty-four refinery workers were examined for nickel exposure. Exposure was evaluated based on work task. Stationary and personal
air measurements were collected during the work shift during four consecutive work days. Urine (for four days) and blood samples
(at the beginning and end of the study) were collected . A micronucleus analysis was also conducted to examine effects of Ni on genotoxicity.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Inhalation of nickel dusts and aerosols during Ni refining.

TYPE OF EXPOSURE MEASUREMENT: Area air sampling and personal sampling, Ni speciation not conducted.
Biomonitoring of urine and blood conducted.

EXPOSURE LEVELS: see Table below

EXPOSURE PERIOD: collected during work shifts, approximately 8 hours.

POSTEXPOSURE PERIOD: not applicable

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: examined by work category.

Results and discussion

Results:
For electrowinning operations, soluble nickel was reported to constitute from 86% to 99.7% of the total nickel content of air samples in various areas of an electrowinning facility. Water-soluble nickel sulphate represented more than 95% of the total concentration of nickel in air, except at the
leaching site, where the proportion of water-insoluble nickel was 11%. Data on metallic, sulphidic, or oxidic Ni not reported.
Blood Ni concentrations ranged 18 to 59 nmol/L after the last work day. The maximum individual value was 77 nmol/L.
Average urinary Ni concentrations (after shift) ranged from 0.09 to 1.28 umol/L.
No correlations between breathing zone Ni and blood or urine Ni concentrations was observed.
There was no association between breathing zone Ni and the frequency of micronucleated cells (buccal mucosa).

Applicant's summary and conclusion

Conclusions:
Study provides air Ni exposure concentrations for a nickel refinery.
Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER.

(A detailed description of the scoring criteria can be found in the .pdf document attached to the 'Exposure Scoring Rationale Document' record at the beginning of Section 7.10.5).