Registration Dossier

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:
2010
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
Name:
Unnamed
Type:
Constituent
Details on test material:
see section 1.1

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.