Diammonium hexachloroiridate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1990-1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not a guideline study, but data acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Indium and iridium allergy in patients exposed to dental alloys

Author:

Marcusson JA, Cederbrant K and Heilborn J

Year:

1998

Bibliographic source:

Contact Dermatitis 38, 297-298

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The frequency and relevance of positive skin reactions to ammonium hexachloroiridate was investigated in 210 patch tested patients exposed to dental alloys.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dimmonium hexachloroiridate

IUPAC Name:

Dimmonium hexachloroiridate

Details on test material:

- Name of test material (as cited in study report): ammonium hexachloroiridate.
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Type of population:

other: Patients with suspected hypersensitivity to dental materials.

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 210
- Sex: M/F
- Age: The patients with positive patch tests results to various dental materials ranged from 37 to 71 years-of-age
- Race: no data
- Demographic information: Patients attending the Dermatology clinic at Huddinge Hospital, Stockholm, Sweden

Clinical history:

- History of allergy or casuistics for study subject or populations: All patients had suspected hypersensitivity to dental materials.
- Symptoms, onset and progress of the disease: no data
- Exposure history: dental amalgams
- Aggravating factors both in home and workplace: no data
- Family history: no data

Controls:

None

Route of administration:

dermal

Details on study design:

Template option: Skin sensitisation

TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semi-occlusive
- Description of patch: Finn chamber
- Vehicle / solvent: no data
- Concentrations: 0.01, 0.032, 1% for ammonium hexachloroiridate
- Volume applied: no data
- Testing/scoring schedule: Patch applied for 2 days to the upper back. Readings were made two day after patch removal, and patients were asked to report late reactions.
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system: + weak non-vesicular reaction; ++ strong oedematous vesicular reaction: +++ extreme reaction (only ++ and +++ reactions, or a + reaction for at least two concentrations, were accepted as positive findings.
- Statistical analysis: no data

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: A + reaction was seen in one female at the highest concentration only.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1/210
- Number of subjects with negative reactions: 209/210

Applicant's summary and conclusion

Conclusions:

Only one female (out of 210 patients) had a weak positive reaction to 1% diammonium hexachloroiridate two days after removal of a 48-hr, semi-occluded, patch test.

Executive summary:

A total of 210 patients with suspected hypersensitivity to dental materials were patch tested with 0.01, 0.032 and 1% diammonium hexachloroiridate, and assessed for frequency and relevance of positive reactions (indicative of sensitisation). Patches were applied semi-occluded (Finn chamber) for two days to the upper back. Readings were made 2 days after patch removal, and in addition patients were asked to report any late reactions. Reactions were graded as + (weak non-vesicular reaction), ++ (strong oedematous vesicular reaction) or +++ (extreme reaction).

 

A 42-year-old female had a weak reaction to 1% diammonium hexachloroiridate. No other positive reactions indicative of skin sensitisation were reported.