Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal.
Justification for type of information:
Data is from peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Incidence of metal sensitivity in patients with total joint replacements.
Author:
M W ELVES, J N WILSON, J T SCALES, H B S KEMP
Year:
1975
Bibliographic source:
British medical journal 15 November 1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To observed the effect of ammonium molybdate which was used in patch test to 50 patient using Al-test strips.
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): ammonium molybdate(VI)
- Molecular formula: MoO4.2H4N
- Molecular weight: 196.0132 g/mol
- Smiles notation: [Mo](=O)(=O)([O-])[O-].[NH4+].[NH4+]
- InChl: 1S/Mo.2H3N.4O/h;2*1H3;;;;/q;;;;;2*-1/p+2
- Substance type: Inorganic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): ammonium molybdate(VI)
- Molecular formula: MoO4.2H4N
- Molecular weight: 196.0132 g/mol
- Smiles notation: [Mo](=O)(=O)([O-])[O-].[NH4+].[NH4+]
- InChl: 1S/Mo.2H3N.4O/h;2*1H3;;;;/q;;;;;2*-1/p+2
- Substance type: Inorganic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: Human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
1%
Day(s)/duration:
3 days
No. of animals per dose:
50 patient
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 3 days
- Test groups: 50 patient
- Site: on the back and held in place with hypoallergic tape
- Frequency of applications: 1
- Duration: 3 days
- Concentrations: 1%
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: induction
Group:
test group
Dose level:
1% of ammonium molybdate
Total no. in group:
50
Clinical observations:
No reaction was observed
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

score used for observation

·         + erythema

·         ++ vesicular rash confined to area of patch

-      +++- extensive eczematous reaction beyond area of patch

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The ammonium molybdate (13106-76-8) was determined to be non-sensitizing to human after exposure.
Executive summary:

Patch test was performed on 50 patient using Al-test strips to the pads of which were applied the metal allergens. Ammonium molybdate was placed on back and held in place with hypoallergic tape. Patch was kept for 3 days and again the test site was examined on seventh day.

No sensitivity was observed for ammonium molybdate, therefore ammonium molybdate (13106-76-8) was considered to be non-sensitizing to human after exposure.