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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2018-03-26 to 2018-03-26
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
2015-07-28
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ICCVAM: CORROSITEX: An in vitro test method for assessing dermal corrosivity potential of chemicals.
Version / remarks:
1999-06
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2015-06-05

Test material

Constituent 1
Reference substance name:
Oleic acid, copper salt
EC Number:
233-866-5
EC Name:
Oleic acid, copper salt
Cas Number:
10402-16-1
IUPAC Name:
(9Z)-Octadec-9-enoic acid
Test material form:
other: highly viscous, sticky
Details on test material:
- State of aggregation: highly viscous, sticky, green-blue
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in a sealed 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:
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. 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: yes
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. 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 oleic acid, copper salts was incompatible with the CORROSITEX™ Assay, as assessed in the qualification step.

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