Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No EU TG or OECD guidelines are available for epidemiological evaluation of respiratory tract irritation. Survey design was well described, with correlation of measured and estimated exposures with respiratory symptoms reported by questionnaires. According to the EU RAR, 2007 (section 4.1.2.3.3, page 69), this was a reliable study.

Data source

Reference
Reference Type:
publication
Title:
Respiratory Morbidity and Exposure to Bauxite, Alumina and Caustic Mist in Alumnia Refineries
Author:
Fritschi L. , Klerk N, Sim M, Benke G, Musk AW
Year:
2001
Bibliographic source:
J Occup Health; 43: 231-237

Materials and methods

Study type:
self-reporting of symptoms
Endpoint addressed:
respiratory irritation
Principles of method if other than guideline:
A cross-sectional survey of 2404 employees in the three alumina refineries was performed in 1996. The participants answered questions about respiratory symptoms and the relationship of those symptoms to work, as well as having spirometry and providing a complete job history.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): caustic mist

Method

Type of population:
occupational
Ethical approval:
not specified

Results and discussion

Results:
Subjects in the highest group of current caustic exposure reported increased prevalence of work related wheeze (Prevalence ratio = 1.8; 95%; CI: 1.0-3.1) and rhinitis (Prevalence ratio = 1.6; 95%; CI: 1.1-2.4), but did not have measurable changes in lung function.
There were no significant differences in FEV1 between caustic exposure groups, but those in the highest two exposure groups had significantly increased FVC. There were no differences in these results when these analyses were restricted to those who had ever worked in the production jobs.
In this study, exposure concentrations up to 1 mg/m3 were not considered adverse with regard to local effects to the respiratory tract.

Any other information on results incl. tables

Results are based on questionnaires which are considered to give a more representative picture of respiratory tract irritation among workers since it is not expected that all workers with respiratory tract irritation have visited a medical department.

Applicant's summary and conclusion

Conclusions:
Subjects in the highest group of current caustic exposure reported increased prevalence of work related wheeze (Prevalence ratio = 1.8; 95%; CI: 1.0-3.1) and rhinitis (Prevalence ratio = 1.6; 95%; CI: 1.1-2.4), but did not have measurable changes in lung function.
There were no significant differences in FEV1 between caustic exposure groups, but those in the highest two exposure groups had significantly increased FVC.