Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: Report on medical surveillance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Human exposure on specific chemicals. Even if not GLP the reliability of the study is very high.

Data source

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

Materials and methods

Type of sensitisation studied:
respiratory
skin
Study type:
other: medical surveillance at manufacturing site
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 15 per year; 12 have been employed since 2008
- Sex: male/female
- Age: occupational life span
Clinical history:
All workers are routinely controlled once in a year and in case of accidents.
Controls:
Yearly
Route of administration:
other: Dermal and inhalation
Details on study design:
Manufacturing is in batch in closed system. Exposure may occur during discharge and maintenance.

Results and discussion

Results of examinations:
No sign of sensitisation has ever been detected.

Applicant's summary and conclusion

Conclusions:
No workers have ever experienced sensitisation to the substance.
Executive summary:

The substance has been manufactured since 2008 on three rolls composed by 4 workers each. On a daily basis, 12 workers are exposed to the substance during discharge and maintenance. In total 15 workers may be in contact with the substance. Among those, 12 have been employed since 2008 and working in the manufacturing of the substance.

No workers have ever experienced sensitisation to the substance.