Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: medical monitoring
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This statement is made by an experienced occupational physician after serious investigation of available data of health complaints and adverse reaction reports made on workers working in the production of Hostaonx SE 10

Data source

Reference
Reference Type:
other: company data
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Study type:
medical monitoring
Remarks:
by occupational medicine
Endpoint addressed:
other: medical surveillance
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Supervision by occupational medicine of workers in the production plant.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Several commercial types of the applicant

Method

Type of population:
occupational
Ethical approval:
not applicable
Details on study design:
n.a.

Results and discussion

Results:
In a retrospective view on occupation medical data of production workers exposed to Hostanox SE 10 no cases of illness or other health effetcs were reported.

Applicant's summary and conclusion

Conclusions:
Workers (exposed to Hostanox SE 10 by production process) were observed by occupational physicians. No cases of illness or other health effetcs were reported.
Executive summary:

Please refer to "Conclusions"