Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)

EC Number:

807-888-6

Cas Number:

110621-40-4

Molecular formula:

Al10.33Mg0.67Na1.67O17

IUPAC Name:

Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)

Specific details on test material used for the study:

Name of test substance: ß''-Alumina (BASF)
Test-substance No.: 16/0110-1
Batch identification: 10978-52 H_K
CAS No.: 110619-69-7
Content: 90.8 % Sodium magnesium aluminium oxide (Na1.67Mg0.67Al10.33O17). Based on the XRD data, performed under non-GLP conditions, a content of approx. 82 g/100 g (90.8% from approx. 90%) of the crystalline fraction Na1.67Mg0.67Al10.33O17 can be calculated.
Identity: Confirmed (for details see Study code: 16L00115)
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this
responsibility. The test facility is organizationally independent from the BASF SE sponsor division.
pH-value: Ca. 10 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study)
Physical state / color: Solid / white
Storage conditions: Room temperature, protect against humidity

In vitro test system

Test system:

artificial membrane barrier model

Remarks:

reconstituted collagen matrix

Vehicle:

unchanged (no vehicle)

Details on test system:

The Corrositex® assay is a standardized in vitro corrosion test. The Corrositex® assay kit is commercially available from InVitro International. The Corrositex® Biobarrier Membrane is a 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). The Corrositex® assay is used to determine the corrosive potential of test substances. The assay is limited to testing those materials which cause detectable pH changes in the CDS.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

500 mg of undiluted test substance

Duration of treatment / exposure:

60 minutes

Number of replicates:

4

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

mean

Value:

> 60

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

ß''-Alumina does not show a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen.

Executive summary:

The potential of ß''-Alumina (BASF) 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 2 (having a low acid/alkaline reserve). In the main test four Corrositex® Biobarrier Membranes were treated with the undiluted test substance. The test substance did not break through the Corrositex® Biobarrier Membrane within the maximum observation period of 1 hour. Based on the observed results and applying the evaluation criteria described above, it was concluded, that ß''-Alumina (BASF) does not show a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen.