Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study conducted according to OECD Guideline 435

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Physical state: solid, yellowish
- Analytical purity: Aluminium: 20.5 g/100 g; Chloride: 80.0 g/100 g
- Lot/batch No.: 34172868E0
- Storage condition of test material: Room temperature; dry storage, protect against humidity

Test animals

Species:
other: Corrositex® Biobarrier Membrane

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
500 mg per disc

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: mean breakthrough time through Corrositex® Biobarrier Membrane in minutes
Value:
16.87
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: The mean breakthrough time of the test substance in 4 vials was 16 minutes 52 seconds. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that Aluminium chloride anhydrous screened (PRD 30046443) shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean breakthrough time determined in the in vitro membrane barrier test was 16 minutes and 52 seconds. The breakthrough time indicates that the test substance has an intermediate corrosive potential and should be assigned to UN GHS skin corrosivity subcategories 1B or UN Transport Packing Group II as specified in OECD TG 435 (adopted 19 July 2006).
Executive summary:

The potential of Aluminium chloride anhydrous screened (PRD 30046443) to cause dermal corrosion was assessed by a single topical application of 500 mg of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay).

The Corrositex® Biobarrier Membrane is the test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS).

In addition to the test substance a positive and a negative control were assessed.

The Corrositex® assay showed the following results:

The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore the membrane barrier test method was determined to be suitable for the evaluation of the corrosive potential of the test substance. A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 1 (having a high acid/alkaline reserve). In the main test four Corrositex® Biobarrier Membranes were treated with the undiluted test substance.

The mean breakthrough time of the test substance, determined in the actual Corrositex® assay, was 16 minutes and 52 seconds ( breakthrough times for the individual membranes were 11:08, 19:00, 17:19, and 20:00).

These results indicate a corrosive potential of the test substance.