Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: Health surveillance
Adequacy of study:
weight of evidence
Reliability:
other:
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This statement is made by an experienced occupational physician after serious investigation of available data of occupational health surveillance he (since 1993) and his predecessors performed of workers working up to 26 years in the production of crystalline calcium silicate hydrate (xonotlite - tobermorite)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2010

Materials and methods

Study type:
medical monitoring
Remarks:
annual occupational health check-up
Test guideline
Qualifier:
according to
Guideline:
other: National legislation with additions
Deviations:
no
Principles of method if other than guideline:
Human health experience with the substance comes from the occupational health surveillance of workers in the production plant in Tisselt (Willebroek), Belgium.
Since 1984 an average of about 150 employees are working in the plant. On average 3 to 4 of them were/are exposed 8 hours a day at 200 days a year to calcium silicate dust in concentrations ranging from <0,5 to 2 mg/m³ (respirable fraction, 99% calcium silicate dust ). The others were exposed to comparable dust levels containing various percentages calcium silicate.

The plant is producing, processing and handling calcium silicate since 1984. Consequently since this time there is respiratory exposure of calcium silicate dust to the workers. During the whole period the workers of the production plant have been included in a health surveillance program. Some workers have already been working in this company for 40 years and many of them are actually still working.

No cases of lung fibrosis or work-related obstructive or restrictive lung effects have been observed in the period between 1984-2010.

The company’s occupational health service is full-time available and workers are incited to always report any health complaints or adverse reactions.
Pulmonary function of every worker has been annually examined (with a lung diffusion test every 3 years) and documented.
Until recent years, all workers also had an annual chest roentgenograph (large format X-ray). No cases of lung diseases or changes of pulmonary function that may be related to calcium silicate dust exposure have been observed.
GLP compliance:
no
Remarks:
not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Not relevant

Method

Type of population:
occupational
Ethical approval:
not applicable
Remarks:
Observational study
Details on study design:
not relevant

Results and discussion

Results:
In a retrospective view on occupation medical data of production workers exposed to calcium silicate dusts in the period between 1984 to 2010 no cases of (non-fibrous) mineral dust related lung diseases have been observed. Since 1984 pulmonary function of about 150 workers are annually examined and documented without any change of pulmonary function concerning calcium silicate dust.

Applicant's summary and conclusion

Conclusions:
In a retrospective view on occupation medical data of production workers exposed to calcium silicate dusts in the period between 1984 to 2010 no cases of (non-fibrous) mineral dust related lung diseases have been observed. Since 1984 pulmonary function of about 150 workers are annually examined and documented without any change of pulmonary function concerning calcium silicate dust.
Executive summary:

In a retrospective view on occupation medical data of production workers exposed to calcium silicate dusts in the period between 1984 to 2010 no cases of (non-fibrous) mineral dust related lung diseases have been observed. Since 1984 pulmonary function of about 150 workers are annually examined and documented without any change of pulmonary function concerning calcium silicate dust.