Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not conducted to GLP or standard methodology, follows basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis and contact sensitisation among enamellers and decorators in the ceramics industry
Author:
Motolese A, Truzzi M, Giannini A and Seidenari S
Year:
1993
Bibliographic source:
Contact Dermatitis, 28:59-62

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
190 workers (119 females and 71 males) from 5 ceramics factories underwent dermatological and allergological examination using occupational test series. Manganese dioxide was used as a 10% in petrol. Patch tests were applied to healthy skin on the back, removed after 2 days and read 1 day later.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Subjects:
All subjects work within the ceramic industry and are exposed to chemicals such as manganese dioxide on a daily basis.
Route of administration:
dermal

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:2

OTHER RESULTS: contact dermatitis was also present

Applicant's summary and conclusion

Conclusions:
Two people out of 190 tested with MnO2 showed an effect, compared to 28 out of 190 for NiSO4 which is regarded as a sensitiser. The small number is not regarded as substantial, as would be required by CLP in order to trigger classification. It is also much less then the NiSO4. It is considered therefore that this result supports the negative LLNA result for this substance.