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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Type of study / information:
Measured levels of dermal exposure of Ni in refinery workers.
Endpoint addressed:
not applicable
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study compared levels of nickel on the skin of nickel refinery workers (hands, forearms, neck, face and chest) from various refinery task areas topredicted exposure levels.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nickel hydroxycarbonate
- 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: nickel matte
- Other details on test material not reported or not applicable

Method

Ethical approval:
not applicable
Details on study design:
Dermal exposure samples were collected using moist wipes swabbed over the skin. Samples were collected from hands, forearms, neck,
face, and chest of refinery workers. Soluble and insoluble Ni was measured by ICP-AES.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: dermal exposure

TYPE OF EXPOSURE MEASUREMENT: moist swabbs on skin to recover nickel

EXPOSURE LEVELS: see table below

EXPOSURE PERIOD: not reported

POSTEXPOSURE PERIOD: not applicable

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: reported by workplace and task

Results and discussion

Results:
Exposure levels presented in Table above. Authors reported that exposure levels were lower than expected for this industry.

Applicant's summary and conclusion

Conclusions:
Median soluble and insoluble exposures ranged from 0.24 - 2.6 and 0.15 - 6.4 ug Ni/cm2 skin, respectively.
Executive summary:

Hughson (2004) reported on a study comparing levels of nickel on the skin of nickel refinery workers (hands, forearms, neck, face and chest) from various refinery task areas to predicted exposure levels. Estimates of exposure to soluble and insoluble nickel compounds were derived using the European Union’s Existing Substances Risk Assessment (EASE) model for workers at two different nickel refineries; this model incorporated various job tasks. The author mentioned nickel hydroxycarbonate as one of the compounds to which the workers of the nickel packing area would have been exposed. The dermal nickel samples were collected by swabbing commercial moist wipes over measured areas of the skin. Each wipe sample was analyzed for soluble and insoluble forms of nickel using Inductively Coupled Plasma-Atomic Emission Spectrometry, and the quantity of nickel in each wipe sample was used to determine the amount of nickel on each anatomical area.

The concentrations of nickel in skin samples collected from refinery workers performing various tasks were reported as follows (50th and 90th percentile for combined hands and arms of three to nine samples for both soluble and insoluble nickel; Nisol and Niinsol, respectively): leaching plant (0.24, 0.25 μg Nisol/cm2 skin; 0.15, 0.27 μg Niinsol/cm2 skin), electro-winning (0.25, 0.88 μg

Nisol/cm2 skin; 0.08, 1.0 μg Niinsol/cm2 skin), cathode cutting (0.26, 0.31 μg Nisol/cm2 skin; 0.36, 0.63 μg Niinsol/cm2 skin), nickel powder packing (2.6, 4.4 μg Nisol/cm2 skin; 6.4, 11 μg Niinsol/cm2 skin), nickel briquette packing (0.24, 0.74 μg Nisol/cm2 skin; 0.9, 6.04 μg Niinsol/cm2 skin), and nickel compound packing (0.39, 0.66 μg Nisol/cm2 skin; 0.18, 0.4 μg Niinsol/cm2 skin). The correlations of dermal nickel levels among the different anatomical areas were all significant. The author stated that the dermal exposures were less than predicted values generated by the EASE model, and the dermal nickel levels were much lower than levels measured in the zinc industry. However, no data or analyses were provided on either of these comparisons to support these claims. In addition, although the highest levels were observed among the nickel powder packing workers, the author indicated that an evaluation of the physical properties of the nickel species to which workers are exposed, rather than just the skin exposure to total nickel levels, should be addressed to provide a more accurate health risk assessment. STUDY RATED BY AN INDEPENDENT REVIEWER.