Naphthenic acids, copper salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2018-06-19 to 2018-06-19

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:

signed 2018-04-26

Test material

Test material information

Constituent 1

Reference substance name:

Naphthenic acids, copper salts

EC Number:

215-657-0

EC Name:

Naphthenic acids, copper salts

Cas Number:

1338-02-9

IUPAC Name:

copper(2+) bis(3-(3-ethylcyclopentyl)propanoate)

Test material form:

liquid: viscous

Remarks:

liquid, viscous, paste

Details on test material:

- State of aggregation: liquid, viscous, green paste

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: -15°C to 40°C

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:

Corrositex TM is a validated and accepted in vitro method to assess if a test item can produce skin corrosion and to distinguish between GHS corrosivity categories 1A, 1B, and 1C.

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. 150 µL of the test substance are added to the Qualify test tube. The vial was shaken to allow dissolution of the test substance and let stand for one minute. 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
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 required

Amount/concentration applied:

TEST MATERIAL (Qualification Step)
- Amount(s) applied (volume or weight with unit): approx. 150 µL 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 naphtenic acids, copper salts was incompatible with the CORROSITEX™ Assay, as assessed in the qualification step.