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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Ca. 2 months
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study not to GLP or guideline, but follows basic scientific principles. Human data, multiple metallic substances tested at the same time.

Data source

Reference
Reference Type:
publication
Title:
Hypersensitivity to metals in orthodontics
Author:
Menezes LM, Campos LC, Quintao CC and Bolognese AM
Year:
2004
Bibliographic source:
American Journal of Orthodontics and Dentofacial Orthopedics. 126:58-64

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
PATCH TEST METHOD: 2 pieces of adhesive tape approximately 15cm in length were used for each patient. The test material (in strips) was attached to these adhesive tapes and applied to the skin. Exposure period: 48 hours.
After 48 hours the strips were removed and residues cleaned with alcohol. The areas was marked with a skin-marking pen and evaluated by a dermatologist . The test area was read again at 30 mins (post-removal) and 72 hours (post-application), In order to distinguish doubtful reactions from mild positive reactions.
In cases of true allergenicity an increase in the intensity of the response was expected. Test areas were evaluated according to International Research Contact Dermatitis Group Guidelines: Scores 0-1 = negative, Scores 2-5 = positive reaction.

TREATING SCHEDULE: patch tests were carried out at the start of the study following with patients were referred to a specialist for placement of the orthodontic appliances. Another patch test was conducted two months after placement.
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details provided

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
No details provided

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Remarks:
not described, could be solution, or an inert paste?
Concentration / amount:
1% MnCl2
Challenge
Concentration / amount:
1% MnCl2
No. of animals per dose:
1 dose group: 38 subjects ( 17 male, 21 female)

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Remarks on result:
other: see remarks
Remarks:
Manganese chloride caused a small percentage of positive reactions in both tests, however it is not considered that three people out of 38 (before appliance added) or 1 out of 38 (after appliance added) is a "substantial number " (as required by CLP) of persons.

Applicant's summary and conclusion

Interpretation of results:
ambiguous
Remarks:
Migrated information Although study reports statistical significance for MnCl2, 3 out of 38 or 1 out of 38 would not really be considered as substantial, which would be required by CLP to assign MnCl2 as a sensitiser.
Conclusions:
Manganese chloride caused a small percentage of positive reactions in both tests, however it is not considered that three people out of 38 (before appliance added) or 1 out of 38 (after appliance added) is a "substantial number " (as required by CLP) of persons. Therefore for the purpose of use in read-across to classification of MnSO4, based on the lack if a substantial number of persons, the statistical significance assigned to the result in this study is disregarded, and does not indicate that MnSO4 should be classified.