Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: Medical Statement
Adequacy of study:
supporting study
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:
2009
Report Date:
2009

Materials and methods

Study type:
health record from industry
Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Ethical approval:
not applicable

Results and discussion

Results:
On behalf of the company, the company medical officer studied, whether there are any indications given that a long-term exposure of the substance may induce health effects on affected employees.
In order to investigate correlating indications all available health records from employees working in the production area with occupational relevance concerning possible effects on the health were evaluated. The assessment includes all the data from employees who have been examined by the company’s medical officer between 2006 and 2009 and additionally who had attended at least two routine examinations since their beginning of work. The research includes also the medical information exchange with the former company medical officer, Dr. Hoffmann who was on duty for L. Brüggemann KG Company for more than 21 years. No health effects could be revealed which can be traced back to a continuous, long-term usage of the substance.
In particular, there was no indication of an increase of skin problems caused by exposure SFS, 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. No indication of a development of malignant neoplasia was observed among the examined employees. No indication of specific target-organic toxicity could be determined. This also applies for effects on the respiratory tract and the mucous membranes.

Applicant's summary and conclusion

Executive summary:

No indication of an increase of skin problems caused by exposure of the substance, No corrosive/irritation effects and allergic skin sensitization. Neither reductions of the pulmonary function nor any indication for an inhalative sensitization due to the inhalation of product dust were reported.

No indication of a development of malignant neoplasia was observed, no indication of specific target-organic toxicity determined. Also no effects on the respiratory tract and the mucous membranes reported.