2-ethylhexanoic acid, copper salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2018-05-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

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:

2018-04-26

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexanoic acid, copper salt

EC Number:

244-846-0

EC Name:

2-ethylhexanoic acid, copper salt

Cas Number:

22221-10-9

Molecular formula:

C16H30O4Cu

IUPAC Name:

copper(2+) bis(2-ethylhexanoate)

Test material form:

solid: particulate/powder

Details on test material:

Appearance: Green powder

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, closed, dry

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

Vehicle:

unchanged (no vehicle)

Details on test system:

SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: yes
- Components:qualify test tubes

WAS THE COMPATIBILITY TEST PERFORMED: yes
This step ensures that the sample is compatible with the CORROSITEX™ system. 100 mg of the test substance are added to the Qualify test tube. Solids were shaken to dissolve solids, if necessary. If the colour or consistency of the CDS changes at the sample/testing fluid interface, the test material is qualified for the assay. If no reaction is observed within five minutes, the sample is not qualified for the CORROSITEX™ Assay.

WAS THE TIMESCALE CATEGORY TEST PERFORMED: no
The categorisation step could not be performed, since the substance was incompatible with the Corrositex assay, as assessed in the qualification step.

TEMPERATURE USED DURING TREATMENT: room temperature

METHOD OF DETECTION
- Chemical or electrochemical detection system: chemical detection system

METHOD OF APPLICATION (CLASSIFICATION TEST):
The classification step could not be performed, since the substance was incompatible with the Corrositex assay, as assessed in the qualification step.


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 specified

Amount/concentration applied:

TEST MATERIAL (Qualification Step)
- Amount(s) applied (volume or weight with unit): approx. 100 mg of the test item

Duration of treatment / exposure:

5 minutes (Qualification Step)

Duration of post-treatment incubation (if applicable):

not applicable

Number of replicates:

not applicable

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other:

Remarks on result:

other: The substances was incompatible with the Corrositex Assay, as assessed in the qualification step.

Other effects / acceptance of results:

QUALIFICATION TEST
The test substance was not able to activate the CDS within 5 min in the qualification step. 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 copper 2-ethylhexanoate was incompatible with the CORROSITEX™ Assay, as assessed in the qualification step. The following categorization step and the classification step could not be performed.