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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:
weight of evidence
Study period:
26 April 2017 - 30 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to
Guideline:
other: B.40 bis (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Source species:
other: EpiDermTM Kit
Cell type:
non-transformed keratinocytes
Details on animal used as source of test system:
Epi-200 kits and MTT-100 assays were purchased from MatTek Corporation (Bratislava, Slovakia). EpiDerm™ tissues were shipped at 4 °C on medium-supplemented agarose gels in a 24-well plate. On day of receipt the pre-incubation phase of the EpiDerm™ tissues started.
Justification for test system used:
The EpiDermTM is an in vitro system recommended by the corresponding guideline.
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200 Kit
- Tissue batch number: 25811
- Date of initiation of testing: 2017-05-10

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C for 3 minutes; room temperature for 60 minutes

REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 20 times
- Observable damage in the tissue due to washing: none

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Spectrophotometer: Versamax Molecular Devices, Softmax Pro
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: 2

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA
The test substance is considered to be corrosive to skin if:
- < 50% after 3 minutes exposure
- ≥ 50% after 3 minutes exposure AND < 15% after 60 minutes exposure
The test substance is considered to be non-corrosive to skin if:
- ≥ 50% after 3 minutes exposure AND ≥ 15% after 60 minutes exposure
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount applied: 50 µL
Duration of treatment / exposure:
3 min and 60 min
Number of replicates:
2

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: Relative Absorbance (% of Negative Control)
Run / experiment:
1_Exposure: 3 min
Value:
103.9
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
other: Relative Absorbance (% of Negative Control)
Run / experiment:
2_Exposure: 3 min
Value:
107.6
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
other: Relative Absorbance (% of Negative Control)
Run / experiment:
1_Exposure: 1 h
Value:
123.4
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
other: Relative Absorbance (% of Negative Control)
Run / experiment:
2_Exposure: 1h
Value:
126.5
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: none
- Colour interference with MTT: none

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is non corrosive to skin according to EU CLP and UN GHS.
Executive summary:

An in vitro study was performed to assess the corrosive potential of the test item by means of the Human Skin Model Test with EpiDerm™ tissues models.

The test item passed the pre-test for colour interference and for direct MTT reduction. Consequently, additional tests were not necessary.

Independent duplicate tissues of EpiDerm™ were exposed to either the test item, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively. After exposure of the tissues to the test item the relative absorbance value did not decrease (105.7%) after 3 minutes exposure. After 1 hour exposure the relative absorbance value was also not reduced (124.9%). Both values did not affect the threshold for corrosiveness which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. The required acceptability criteria were met. The test item is not considered to be corrosive.