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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
MTDID 17081
IUPAC Name:
MTDID 17081
Test material form:
other: liquid

Test animals

Species:
other: in vitro method
Strain:
other: in vitro method
Details on test animals or test system and environmental conditions:
TEST SYSTEM: Reconstructed human epidermal tissue (EpiDerm EPI-200 model).

Test system

Type of coverage:
other: not applicable: in vitro method
Preparation of test site:
other: not applicable: in vitro method
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable: in vitro method
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
3 minute and 1 hour exposures were conducted.
Observation period:
Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 µL MTT medium and then all tissues were again incubated for 3 hours at 37 C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol.
Number of animals:
None: in vitro method
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS).
- Time after start of exposure: 3 minutes or 1 hour.

SCORING SYSTEM: The DMEM medium was replaced with 300 µL MTT medium and then all tissues were again incubated for 3 hours at 37°C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minute and 1 hour exposure
Value:
ca. 70 - 89
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Not corrosive in vitro
Other effects / acceptance of results:
The mean tissue viability of the test article was 70% of the negative control after a 3 minute exposure and 89% after 1 hour exposure. The controls performed as expected indicating that the test was valid.

Applicant's summary and conclusion

Interpretation of results:
other: Not corrosive
Conclusions:
Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model.
Executive summary:

The skin corrosion potential of the test article (clear colourless liquid, Purity: 99.64%, Lot: 12912) was evaluated in an in vitro human skin model test. This study was performed in compliance with OECD GLP (1997). The study design was based on OECD Guideline No. 431 (2013) and EC 440/2008 (2008).

 

Human-derived keratinocytes were cultured to form a multi-layered, highly differentiated model of the human epidermis (EpiDerm EPI-200 model). The tissues were kept refrigerated until the day of use, transferred to 6 well plates containing 0.9 mL DMEM medium, and then incubated for 2 hours at 37°C in 5% CO2. The test article (50 µL) was applied to 2 tissues for a 3 minute exposure and to 2 tissues for 1 hour exposure. The negative control (Milli-Q water) and the positive control (8N Potassium hydroxide) were applied (50 µL of each) in the same manner. Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 µL MTT medium and then all tissues were again incubated for 3 hours at 37°C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements.

 

The mean tissue viability of the test article was 70% of the negative control after a 3 minute exposure and 89% after 1 hour exposure. The controls performed as expected indicating that the test was valid.

 

Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model.