Registration Dossier
Registration Dossier
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EC number: 205-739-4 | CAS number: 149-44-0
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- other: Medical Statement
- Adequacy of study:
- weight of evidence
- Study period:
- 1976 - 2010
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Comprising epidemiological judgment based on occupational health examinations.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Occupational Medical Assessment
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydroxymethanesulphinate
- EC Number:
- 205-739-4
- EC Name:
- Sodium hydroxymethanesulphinate
- Cas Number:
- 149-44-0
- Molecular formula:
- CH4O3S.Na
- IUPAC Name:
- sodium hydroxymethanesulphinate
- Details on test material:
- see section 1.1
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: n.a.
- Sex:
- male
Test system
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- other: n.a.
- Vehicle:
- unchanged (no vehicle)
- No. of animals per dose:
- No. of employees: 33.
The period of employment varies from 4 years as a minimum to 34 years as a maximum. The average age was determined to be 48.3 years while the average period of employment amounts to 15.1 years.
Results and discussion
- Results:
- The study of company medical officer did not reveal any significant health effects on affected employees in the case of long-term exposure with the substance.
In particular, there was no indication of an increase of skin problems caused by exposure, e.g. corrosive/irritation effects and allergic skin sensitization of the employees with long-term exposure can practically be excluded. Moreover, neither reductions of the pulmonary function appeared nor any indication for an inhalative sensitization due to the inhalation of product dust was given.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- No indication for an inhalative sensitization due to the inhalation of substance dust is given.
- Executive summary:
Based on an observation of 33 male employers at an average age of 48.3 a and an average period of employment of 15.1 a, no indication for an inhalative sensitization due to handling with the substance dust is given.
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