Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: survey
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: survey of exisiting occupational asthma cases

Data source

Reference
Reference Type:
other: Survey
Title:
Survey of existing occupational asthma cases related to Naphthenic acids, zinc salts, basic (CAS: 84418-50-8)
Author:
EBRC Consulting GmbH
Year:
2020
Report date:
2020

Materials and methods

Type of sensitisation studied:
respiratory
skin
Study type:
survey
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A questionnaire was developed focussing on the potential of Naphthenic acids, zinc salts, basic to cause respiratory (and skin) sensitisation.

Test material

Constituent 1
Reference substance name:
Naphthenic acids, zinc salts, basic
EC Number:
282-762-6
EC Name:
Naphthenic acids, zinc salts, basic
Cas Number:
84418-50-8
Molecular formula:
Not available
IUPAC Name:
Naphthenic acids, zinc salts, basic

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
- Number of workers exposed: 38 workers (in 2019)
Clinical history:
- Number of workers undergo regular health surveillance: 38 workers (in 2019); 143 workers (last decade)
- Number of workers undergo regular lung function testing: 31 workers (in 2019); 130 workers (last decade)

Results and discussion

Results of examinations:
- Number of workers with respiratory sensitisation symptoms: 0 (in 2019), 0 (last decade)
- Number of workers with dermal sensitisation (allergic contact dermatitis): 0 (in 2019), 0 (last decade)
- Number of workers diagnosed with non-occupational exposure: 0 (in 2019), 0 (last decade)
- Number of workers with impaired lung function: 0 (in 2019), 0 (last decade)

Applicant's summary and conclusion

Conclusions:
Three companies that represent all registrants of the substance in Europe responded to the questionnaire. Currently, a total of 38 workers are involved in the handling and/or processing of the substance in Europe. None of these workers show symptoms of occupational asthma and/or dermal sensitisation. All workers are also handling other substances that are classified as respiratory sensitisers. In total, 143 workers underwent medical surveillance during the last decade, again without any clinical signs of respiratory sensitisation.