Tetraamminepalladium(2+) dinitrate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Published paper, limited reporting. Data appear scientifically acceptable

Data source

Reference

Reference Type:

publication

Title:

Allergy to palladium

Author:

Rebandel P and Rudzki E

Year:

1990

Bibliographic source:

Contact Dermatitis 23, 121-122

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Patch testing of patients with allergic contact dermatitis

Test material

Test material information

Constituent 1

Reference substance name:

Tetraamminepalladium(2+) dinitrate

EC Number:

237-078-2

EC Name:

Tetraamminepalladium(2+) dinitrate

Cas Number:

13601-08-6

Molecular formula:

H12N4Pd.2NO3

IUPAC Name:

Tetraamminepalladium (II) nitrate

Constituent 2

Reference substance name:

Palladium dichloride

EC Number:

231-596-2

EC Name:

Palladium dichloride

Cas Number:

7647-10-1

Molecular formula:

Cl2Pd

IUPAC Name:

palladium(2+) dichloride

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Tetramine palladium nitrate
- Impurities (identity and concentrations): Atomic absorption spectrometry showed less than 0.2 mg nickel per litre (i.e. 0.2 ppm) [the paper erroneously states this to be 0.2%. However, 0.2 mg per litre = 200 mg per 1000 litre, i.e. 0.2 g per 1000 litre = 0.2 ppm; 0.2 mg per litre = 0.02 mg per 100 ml = 0.00002 g per 100 ml = 0.00002%, not 0.2%]

Method

Type of population:

general

Controls:

Not applicable

Route of administration:

dermal

Details on study design:

100 consecutive patients with contact dermatitis were patch tested with 1% palladium (II) chloride and from 1% to 0.001% tetramine palladium nitrate in water, at the Department of Dermatology, Warsaw School of Medicine, Poland. No details on patch tests are presented in the paper, but probably involved 24/48-hour covered contact.

Results and discussion

Results of examinations:

None of the 90 nickel-negative patients reacted to 1% palladium chloride or 1% tetramine palladium nitrate (this group contained 4 patients positive to chromate, 2 positive to chromate and cobalt, and 1% to 0.1% mercuric chloride).

Ten patients (all women) were responsive to both nickel and the palladium compounds at 1%. Eight of these patients were tested with several concentrations of both nickel and tetramine palladium nitrate. The lowest palladium concentrations causing a reaction was 0.5% (nickel content 0.001%) in four of these patients and 1.0% (nickel content 0.002%) in the remaining four. Seven of these eight patients failed to react when patch tested with nickel concentrations higher (0.01 to 1.0%) than the nickel concentrations in the lowest palladium concentrations giving a positive reaction. The remaining patient was positive to the lowest concentration of nickel tested (0.01%) and thus it was not possible to determine the lowest nickel concentration to which she would react; she gave a positive reaction to 0.5% tetramine palladium nitrate (nickel content 0.001%).

Nine of the ten patients reacting to tetamine palladium nitrate had no known previous exposure to palladium.

Applicant's summary and conclusion

Conclusions:

Patch testing of 100 contact dermatitis patients with 0.001 - 1% aqueous tetraamminepalladium (II) nitrate revealed ten (all women) who were responsive to both nickel and the palladium compound.

Executive summary:

Patch testing [probably 24/48 -hour covered contact] of 100 consecutive contact dermatitis patients attending a dermatology clinic in Poland with 1% aqueous tetraaminepalladium (II) nitrate or 1% aqueous palladium (II) chloride revealed ten (all women) who were responsive to both nickel and the palladium compounds. Eight of these were patch tested with 0.001 - 1% tetraamminepalladium (II) nitrate. Seven gave a reaction to a palladium compound concentration (0.5% or 1.0%) with a nickel concentration (0.001% or 0.002%) below the highest nickel concentration not causing a reaction in these patients. One patient who reacted to 0.5% tetraamminepalladium (II) nitrate (nickel content 0.001%) was positive to the lowest nickel concentration tested (0.01%) and it was thus not possible to determine the lowest nickel concentration to which she would react. Nine of the ten patients had no known previous exposure to palladium.