Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
A study of workers’ exposures to the inhalable and ‘total’ aerosol fractions in the primary nickel production industry using mannequins to simulate personal sampling.
Author:
Tsai PJ, Vincent JH.
Year:
2001
Bibliographic source:
Ann Occup Hyg 45: 385-394.

Materials and methods

Type of study / information:
Investigated the difference between inhalable and 'total' aerosol exposures by using a mannequin sampling method.
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 provided below.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Sulfidic ores
- Other details on test material not reported or not applicable

Method

Ethical approval:
not applicable
Details on study design:
Experiments were carried out at 21 work sites located in mining, milling, smelting, and refining works of two primary nickel production companies.
During sampling, mannequins were used to simulate the physical presence of workers and the 'exposures' of these were obtained for strategic
positions at selected work sites. The orientations of each mannequin with respect to the wind were rotated through 90° every hour in order to
simulate the approximate orientation-averaging corresponding to actual workers. Two samplers were placed side-by-side on each mannequin:
the Institute of Occupational Medicine (10M) inhalable aerosol sampler, and the 37-mm plastic cassette widely used as a personal sampler for 'total'
aerosol. Each collected sample was analyzed to obtain both overall dust and overall nickel content. A total of 116 such sample pairs were collected.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: inhalation of nickel aerosols and dusts

TYPE OF EXPOSURE MEASUREMENT: Area air sampling / Personal sampling, ni speciation not conducted

EXPOSURE LEVELS: see table below

EXPOSURE PERIOD: not reported

POSTEXPOSURE PERIOD: not reported

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: evaluated by work area, see table

Results and discussion

Results:
The results show that inhalable aerosol exposure levels-for both overall dust and for total nickel content-were consistently and significantly higher
than the corresponding total aerosol exposure levels. Weighted least squares linear regression yielded (inhalable/'total') aerosol ratios ranging from 1.38 to 3.90 and 1.20 to 4.01, respectively, for overall dust and for total nickel content for different work sites. Comparison of these results with
those from the earlier study of actual workers' personal exposures were in good agreement for most of the work sites studies

Applicant's summary and conclusion

Conclusions:
Mannequin sampling can be useful in occupational hygiene for determining such properties of personal workers' exposures.
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).