Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Health surveillance data

Currently viewing:

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not Reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions
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:
Prevalence of small opacities in chest radiographs of nickel sinter plant workers
Author:
Muir DCF, Julian J, Jadon N, Roos J, Chan J, Maehle W, Morgan WKC
Year:
1993
Bibliographic source:
British J of Industrial Medicine; 50: 428-431

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
repeated dose toxicity: inhalation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The prevalence of small irregular opacities were evaluated in radiographs from 745 nickel sinter plant workers (as classified by five different readers); objective was to investigate whether the inhalation of nickel subsulphide and nickel oxide is associated with fibrosis in the lung
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trinickel disulphide
EC Number:
234-829-6
EC Name:
Trinickel disulphide
Cas Number:
12035-72-2
Molecular formula:
Ni3S2
IUPAC Name:
trinickel disulfide
Details on test material:
- Name of test material (as cited in study report): nickel subsulphide and nickel oxide

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
STUDY POPULATION
-workers employed by the International Nickel Company in the sinter plant at Copper Cliff, Sudbury (plant was operational between 1948-1963) that had a chest radiograph for any reason

RADIOGRAPHS
-full sized radiographs of the chest were collected on an annual basis beginning in 1973 as part of a voluntary medical surveillance program
-radiographs from current workers were easily obtained; considerable efforts were made to get radiographs from past workers
-radiographs from civil servants with a similar age range to that of the study population, a well as radiographs from subjects known to have asbestosis, silicosis, or other respiratory diseases were masked and randomized with the study films.

ANALYSIS
-the two most recent films from each worker were classified by five readers using the International Labour Office 1980 protocol.
-evaluations were conducted based on age at time of radiograph as well as duration of exposure (less than or greater than 5 years).

Results and discussion

Results:
-There was no appreciable disease in the study population.
-The number of cases showing round opacities >1/0 was too small for detailed analysis and attention was focused on irregular opacities.
-The percentage of films classified as >0/1, >1/0, and >1/1 (irregular opacities only) for sinter workers with more than 5 years of exposure (percentages for readers 1-5, respectively):
>0/1: 17.4, 7.4, 19.5, 14.8, 12.1
>1/0: 8.7, 2.7, 15.4, 9.4, 7.4
>1/1: 5.4, 1.3, 6.7, 4.0, 6.0

Note: prevalence of small opacities recorded for each reader are provided in the tables below.

Any other information on results incl. tables

Classiciation of films (round opacities only) for sinter plant workers by duration of exposure (five readers)

 Reader  1     2     3     4     5   
 Exposure  <5  >5  <5 >5    <5   >5   <5   >5   <5   >5
 ILO Profusion Score                    
 0.0

 -

 0.1  1  - 1
 1.0  1  1  -  2  -  -
 1.1  -
 1.2  -  -
 2.1  -
 2.2  -
                     

Classiciation of films (irregular opacities only) for sinter plant workers by duration of exposure (five readers)

 Reader  1     2     3     4     5   
 Exposure  <5  >5  <5 >5    <5   >5   <5   >5   <5   >5
 ILO Profusion Score                    
 0.0

 -

 0.1  23 13 22  27 21  35  12 
 1.0  2  2  2  24  13  6
 1.1  4 4
 1.2  - -  1 2
 2.1  - 1 1 1 -1
 2.2  - 1 1 2
 2.3  1
 3.2  1
 3.3  -

Applicant's summary and conclusion

Conclusions:
The authors concluded that the prevalence of small opacities round and irregular combined in the sinter plant workers was low. Because there was a long latent period and a significant number of workers exposed to remarkably high concentrations of dust containing nickel this provided strong evidence that the inhaled dust was not the type causing pneumoconiosis and has low fibrogenic potential.
Executive summary:
Muir et al. (1993) conducted an evaluation of the association between inhalation of nickel subsulfide and nickel oxide and fibrosis in the lung in workers employed by the International Nickel Company in the sinter plant at Copper Cliff, Sudbury. The prevalence of small irregular opacities was evaluated in radiographs collected as part of a voluntary medical surveillance program. The two most recent films from 745 nickel sinter plant workers were evaluated by five separate readers using the International Labour Office 1980 protocol. Results indicated no appreciable disease in the study population based on both round and irregular opacities. The authors concluded that the prevalence of small opacities (round and irregular combined) in the sinter plant workers was low. Because there was a long latent period and a significant number of workers exposed to remarkably high concentrations of dust containing nickel, the authors concluded that this provided strong evidence that the inhaled dust was not the type causing pneumoconiosis and that the dust had low fibrogenic potential. STUDY RATED BY AN INDEPENDENT REVIEWER