Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Summary of case report lacking materials and methods; unclear testing procedure; no controls; styrene was used to occlude some of the patches, but is a skin irritant.

Data source

Reference
Reference Type:
publication
Title:
A case of contact sensitivity to aluminium
Author:
Fischer, T. and Rystedt, I.
Year:
1982
Bibliographic source:
Contact Dermatitis 6:343

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Two subjects that had previously reacted to the Finn Chamber patches with infiltrated, red papular rings, were re-tested. The subjects underwent dermal exposure to aluminium trichloride hexahydrate, and to Finn chambers (made of aluminium), aluminium foil, aluminium acetotartrate, and also received an intracutaneous injection of aluminium hydroxide. The skin reactions were assessed.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): aluminium trichloride hexahydrate (aluminium foil, aluminium acetotartrate and aluminium hydroxide also listed as test materials)
- Molecular formula (if other than submission substance): AlCl3 x 6H2O
- Analytical purity: no data

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 2
- Sex: male
- Other: subjects worked in the hard metal manufacturing industry
Clinical history:
- History of allergy or casuistics for study subject or populations: both subjects participated in a patch test with substances from the industrial environment as part of a skin hazard investigation in the hard metal manufacturing industry. From a total number of 853 participants, 2 showed infiltrated, red papular rings under all Finn chamber patches.
- Other: Subject 1 had regulary used an aluminium chloride roll-on antiperspirant and developed an itchy dermatitis in the axillae after application of an antiperspirant containing aluminium. The patient had not been desensitised with aluminium depot allergens. Subject 2 did not have a history of dermatitis.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test); intracutaneous injection

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Al-test (Imeco Co., Sweden) and 10 mm filter paper discs occluded with 15 mm round styrene plastic pieces. Tests were fixed to the sides of the back with Scanpor tape.
- Vehicle / solvent: water and petrolatum
- Concentrations: 2 and 5% epicutaneous (aluminium trichloride hexahydrate), 1% epicutaneous (aluminium acetotartrate), 0.1% intracutaneous injection (aluminium hydroxide), as is (aluminium foil, Finn chamber)
- Volume applied: no data
- Testing/scoring schedule: no data
- Other: patch tests were performed in duplicate using Al-test in one series and 10 mm filter paper discs occluded with 15 mm round styrene plastic pieces in the other.

EXAMINATIONS
- Grading/Scoring system: no data
- Other: visual examination for skin reaction

Results and discussion

Results of examinations:
RESULT OF CASE REPORT:
In subject 1, patch tests with aluminium trichloride hexahydrate showed ++ reactions in both concentrations. The positive reactions to the Finn Chambers were reproduced twice. There were no positive reactions to the Al-test, aluminium foil or to aluminium acetotartrate. The intracutaneous test with aluminium hydroxide was positive (10 mm) with reactions which appeared after 1 day and disappeared after 7 days. The authors suggest that although the exposure to Finn Chambers produced a reaction, the reason may be contact sensitivity or irritant factor unrelated to aluminium.

In subject 2, the red papular ring of the primary test reactions to the Finn Chambers did not reappear, nor were positive reactions to aluminium trichloride hexahydrate or the other tests demonstrated.

Applicant's summary and conclusion