Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A single case report of allergenic contact dermatitis from a prosthesis containing tantalum. The short communication details the effects of a titanium-tantalum-niobium alloy rather than effects from the pure metal. There is insufficient data presented to conclude on the skin sensitisation potential of tantalum.

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis from tantalum
Author:
Romaguera C & Vilaplana J
Year:
1995
Bibliographic source:
Contact Dermatitis 1995, 32: 184

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A patient with a metal prosthesis made of titanium-tantalum-niobium alloy was observed to have exudative, extremely itchy, papular, erythematous, vesicular lesions on the overlying skin. A TRUE Test standard series of patch tests were conducted and found to give negative results but the augmented special metal series was positive (++) to tantalum chloride 1 % pet at 2 and 4 days. 228 controls, patch tested with the same batch of material were negative. Once the prosthesis was removed, the lesions were seen to disappear.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): titanium-tantalum-niobium alloy

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
male patient with a metal prosthesis made of titanium-tantalum-niobium alloy
Route of administration:
dermal

Results and discussion

Applicant's summary and conclusion

Conclusions:
The paper comments that to the authors' knowledge this is the first case of allergenic contact dermatitis from a prosthesis containing tantalum. Based on the information given in this publication, it is not possible to assess the skin sensitisation potential of tantalum metal.
Executive summary:

In this case study, a patient with a metal prosthesis made of titanium-tantalum-niobium alloy was observed to have exudative, extremely itchy, papular, erythematous, vesicular lesions on the overlying skin. A TRUE Test standard series of patch tests were conducted and found to give negative results but the augmented special metal series was positive (++) to tantalum chloride 1 % pet at 2 and 4 days. 228 controls, patch tested with the same batch of material were negative. Once the prosthesis was removed, the lesions were seen to disappear. The paper comments that to the authors' knowledge this is the first case of allergenic contact dermatitis from a prosthesis containing tantalum.

Overall, the information given in this publication is insufficient to assess the skin sensitisation potential of tantalum metal.