Registration Dossier

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:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Contact Sensitivity to Arsenical Compounds
Author:
Wahlberg, J.E. & 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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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.