Barium 3,5,5-trimethylhexanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-04-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2015-07-28

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2015-06-05

Test material

Test material information

Constituent 1

Reference substance name:

Barium 3,5,5-trimethylhexanoate

EC Number:

252-917-2

EC Name:

Barium 3,5,5-trimethylhexanoate

Cas Number:

36211-43-5

Molecular formula:

C9H18O2.1/2Ba

IUPAC Name:

barium 3,5,5-trimethylhexanoate

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation: solid; white powder

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in a tightly closed container

In vitro test system

Test system:

artificial membrane barrier model

Source species:

other: not specified

Cell type:

other: synthetic macromolecular bio-barrier

Cell source:

other: not specified

Source strain:

not specified

Details on animal used as source of test system:

not applicable

Justification for test system used:

The CORROSITEX™ Assay is a standardized, quantitative in vitro test for skin corrosivity and has been validated by the ECVAM for testing acids, bases and their derivatives (ECVAM, 2000)*. The bio-barrier membrane is constructed to have physico-chemical properties similar to rat skin.

Reference:
- ECVAM (2000) ESAC statement on the application of the Corrositex® assay for skin corrosivity testing

Details on test system:

WAS THE COMPATIBILITY TEST PERFORMED: yes
In order to test whether the test system is suitable for the test item, 100 mg of the test substance was added to the Qualify test tube. The vial was shaken and let stand for one minute. If the colour or consistency of the CDS changes at the sample/testing fluid interface, the test item is qualified for the assay. If no reaction is observed within five minutes, the sample is not qualified for the CORROSITEX TM assay.
The test substance was incompatible with the CORROSITEX™ Assay, as assessed in the qualification step. The categorization step and the classification step could not be performed.

TEST ACCEPTANCE CRITERIA:
The test meets acceptance criteria if:
- test item qualifies in qualification test
- positive control activates CDS > 3 - 60 min.
- negative control activates CDS not before 60 min.
The exact breakthrough time of the positive control should be determined to demonstrate, that the response is in the acceptable historical range of breakthrough times for the positive control (mean ± 2 - 3 standard deviations).

Control samples:

not required

Amount/concentration applied:

not applicable

Duration of treatment / exposure:

not applicable

Duration of post-treatment incubation (if applicable):

not applicable

Number of replicates:

not applicable

Results and discussion

In vitro

Results

Remarks on result:

other: see "Remarks"

Remarks:

Barium bis(3,5,5-trimethyl hexanoate) was not able to activate the CDS within 5 min. in the qualification step. Therefore, the test substance was incompatible with the CORROSITEX™ Assay. The following categorization step and the classification step could not be performed. Hence, the in vitro skin corrosion potential of barium bis(3,5,5-trimethyl hexanoate) cannot be assessed in the membrane barrier test method.

Other effects / acceptance of results:

QUALIFICATION TEST
The test substance was incompatible with the CORROSITEX™ Assay, as assessed in the qualification step. The categorization step and the classification step could not be performed.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The test substance barium bis(3,5,5-trimethyl hexanoate) was not able to activate the CDS within 5 min. in the qualification step. Therefore the test substance was incompatible with the CORROSITEX™ Assay. The following categorization step and the classification step could not be performed.
Due to this technical limitation, the in vitro skin corrosion potential of barium bis(3,5,5-trimethyl hexanoate) cannot be assessed in the membrane barrier test method.