Diarsenic trioxide

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: human data

Adequacy of study:

supporting study

Study period:

September 1981 to June 1982

Reliability:

other: not rated acc. to Klimisch

Rationale for reliability incl. deficiencies:

other: Relevant

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Contact sensitivity to arsenical compounds

Author:

Wahlberg, J.E. and Boman, A.

Year:

1986

Bibliographic source:

Dermatosen 34 (1):10-12

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Routine patch testing with 0.1% (Na2HAsO4 * 7 H2O) in distilled water (pH 8.5) and 0.05% NaAsO2 in distilled water (pH 10.0) was done on 379 consecutive eczema patients at the Department of Occupational Dermatology. AI test patches and Scanpor tape were used.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

sodium dioxoarsenate and disodium hydrogenarsenate

IUPAC Name:

sodium dioxoarsenate and disodium hydrogenarsenate

Constituent 2

Reference substance name:

232-070-5 and 231-902-4

IUPAC Name:

232-070-5 and 231-902-4

Constituent 3

Reference substance name:

7784-46-5 and 7778-43-0

IUPAC Name:

7784-46-5 and 7778-43-0

Details on test material:

- Name of test material: Disodium hydrogen arsenate (pa. Merck AG, Darmstadt, FR Germany)
- Molecular formula (if other than submission substance): Na2HAsO4 * 7 H2O
- Name of test material: Sodium-meta-arsenite (pa. Merck AG, Darmstadt, FR Germany)
- Molecular formula (if other than submission substance): NaAsO2

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 379 consecutive eczema patients

Clinical history:

- Exposure history: patch testing of dermatitis patients with no known exposure to arsenic compounds

Controls:

no data

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
Routine patch testing with 0.1% (Na2HAsO4 * 7 H2O) in distilled water (pH 8.5) and 0.05% NaAsO2 in distilled water (pH 10.0) was done on the patients at the Department of Occupational Dermatology. AI test patches and Scanpor tape were used.

Results and discussion

Results of examinations:

Two of the 379 eczema patients reacted to the arsenic compounds (2 female patients, age 26 and 25). They both showed concomitant and relevant reactions to nickel and one to cobalt. They had hand eczema, but had not experienced any exposure to arsenicals.

Any other information on results incl. tables

ATOMIC ABSORBTION SPECTROPHOTOMETRY

NaAsO2 contained 0.3 ppm cobalt and less than 0.2 ppm nickel and NaHAsO4 less than 0.2 ppm nickel and cobalt.

Applicant's summary and conclusion

Conclusions:

Two of 379 dermatitis patients with no known exposure to arsenic compounds reacted upon patch testing and this reactivity cannot be explained by the concomitant nickel sensitivity since the concentration of nickel and cobalt in the salts used for testing was very low.