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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:
key study
Study period:
From 8 May 2017 to 28 June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
other: reconstructed human epidermis
Details on animal used as source of test system:
Not applicable
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek’s EpiDermTM model
- Tissue batch number(s): Lot# 25816
- Date of initiation of testing: 08 May 17

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C

DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: BMG LabTech FluoStar Optima
- Wavelength: 570 nm
- Filter: None
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μl

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μl

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μl
Duration of treatment / exposure:
3 and 60 minutes
Number of replicates:
Triplicate

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes (mean)
Value:
78.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 minutes (mean)
Value:
86.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Relative mean tissue viability calculated as a percentage of the negative control was 86.9% after the 60 minutes exposure and 78.5% after the 3 minutes exposure. The test item did not meet the criteria for classification as corrosive to the skin according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

The in vitro skin corrosion of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 431. The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Reconstituted Human Epidermis after treatment periods of 3 and 60 minutes. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.

Prior to the testing, the test substance was checked for interference with water and/or MTT. No interference was identified.

Triplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. A MTT assay was performed in order to measure the test viability following the exposure to the test substance. The optical density was measured at 570 nm to determine the concentration of formazan produced by the viable cells from the reduction of MTT. Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).

The Relative mean tissue viability calculated as a percentage of the negative control was 86.9% after the 60 minutes exposure and 78.5% after the 3 minutes exposure. The test item did not meet the criteria for classification as corrosive to the skin according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.