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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study includes a relatively large potential database and includes observations of multiple timepoints.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2008

Materials and methods

Study type:
other: Multi-year observation individuals having been involved with BeO manufacture and processing
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study is part of an observation (1992-2003) of 136 workers who has been involved with BeO manufacture. The current study includes data on sensitisation and diagnosis of chronic beryllium disease.
GLP compliance:
no
Remarks:
Not relevant

Test material

Constituent 1
Chemical structure
Reference substance name:
Beryllium oxide
EC Number:
215-133-1
EC Name:
Beryllium oxide
Cas Number:
1304-56-9
Molecular formula:
BeO
IUPAC Name:
oxoberyllium
Details on test material:
Not clearly defined but BeO from BeO ceramics facility. Exposure comes from a variety of activities and includes inhalation and skin.

Method

Type of population:
occupational
Ethical approval:
confirmed and informed consent free of coercion received
Remarks:
Study approved by the Human Subjects Review Board of the National Institute for Occupational Safety and Health
Details on study design:
A cohort of 136 BeO subjects with known exposure to BeO from a BeO ceramics facility was followed from 1992 to 2003. The cohort was subjected to a survey and a blood sample was drawn for a Be lymphocyte proliferation test. If sensitization was confirmed, the subject was referred to clinical evaluation for diagnosis of Chronic Beryllium Disease.

Results and discussion

Results:
The number of sensitized individuals was increased in 2003 relative to 1992. The work process resulting in the highest level of sensitization was machining with 20 %. Please see Tables 1-4 below for in depth results.

Any other information on results incl. tables

Table 1 Prevalence of sensitisation and Chronic Beryllium Disease (CBD)

 Times tested No. tested  Sensitized (%)  CBD only (%)  % sensitized with CBD  Mean years since hire (range) Mean years since last test (range) 
 1 136   5.9  4.4  75.0  7.7 (0.5 -36.0)  -
 2  106  10.4  7.5  72.7  15.0 (7.7 -47.3)  6.7 (3.2 -12.4)
 3  60  5.0  1.7  33.1  18.3 (11.5 -35.1)  3.2 (2.1 -5.4)
 4  2  0  n/a  n/a  20.6 (20.0 -21.2)  3.2 (3.2)

Table 2 Characteristics of BeO workers according to health status

 Characteristic Not sensitized (n=114)  All sensitized (n=22)  CBD (n=15) Sensitized (not CBD, n=7) 
 Gender 63.2  50.0  46.7  57.1 
 Race/ethnicity  67.5 45.5**  46.7  42.9** 
 Smoker (at any time)  51.8 63.6  46.7  100.0* 
 Average age at hire  32.5 35.1  35.7  33.6 

* 0.05 <=p<0.10

** p<0.05

Table 3 Hazard ratios

  All sensitized    CBD only   
   HR 95 % CI  HR  95 % CI 
 Chronic cough 1.84   (0.80, 4.27) 1.94  (0.71, 5.36)
 Skin problems  1.16  (0.50, 2.68)  2.16 (0.74, 6.32)
 Skin ulcers  1.21  (0.47, 3.09)  1.16 (0.37, 3.65)
 Race/ethnicity (white vs other)  0.40**  (0.17, 0.93)  0.42* (0.15, 1.15)
 Race/ethnicity (hispanic vs other)  2.21*  (0.95, 5.11)  2.43* (0.88, 6.70)

* 0.05 <=p<0.10

** p<0.05

Table 4

 Job or process All sensitized   CBD only   
 HR 95% CI  HR  95% CI 
Production work            
Lapping  1.72  (0.6. 4.36)  1.33 (0.42, 4.16) 
Machining  3.13**  (1.21, 8.06)  4.65** (1.30, 16.61 )
 Forming  2.38*  (0.91, 6.20)  2.10 (0.66, 6.65) 
Firing  2.97*  (0.93, 9.48)  2.37 ( 0.62, 9.06)
Metallisizing  0.41  (0.06, 3.13)  0.62 (0.08, 4.88 )
Tape  0.44  (0.06, 3.42)  0.66 (0.08, 5.50 )
 Material preparation  0.00  -  0.00
Production support            
Janitor/laundry  1.97  (0.45, 8.64)  2.90 (0.63, 13.42 
Packaging  2.57  0.93, 7.08)  2.52 (0.74, 8.58 
Admin-production areas  0.92  0.35, 2.39)  0.95 (0.30, 3.02 
Quality control  1.01  0.41, 2.50)  0.74 (0.24, 2.31 
Maintenance  0.00  -  0.00
Administration            
 Admin-office areas  0.54  0.19, 1.54)  0.29 (0.06, 1.35 

Applicant's summary and conclusion

Conclusions:
There is an increase in the number of workers with Be sensitisation with increased employment and time of exposure. The authors also report that workers hired recently has a significantly lower frequency of sensitisation due to efforts to prevent workers
Executive summary:

A cohort of 136 workers in a BeO ceramics facility were followed from 1992 to 2003. The results from Be Lymphocyte Proliferation Test was compared between 1992 and 2003. The workers were also subject to clinical evaluation of eventual CBD diagnosis. In 1992, a total of 8 (5.8 %) workers were diagnosed with sensititation and 6 of these also had chronic beryllium disease (CBD). In 1998, sensitisation was found in 10 % of the workers and 3.3 % was diagnosed with CBD. Machining was also the activity associated with the highest degree of sensitisation.