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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31-Oct-2011 to 04-Nov-2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Guideline no. 431: In Vitro Skin Corrosion: Human Skin Model Test
Deviations:
no
Qualifier:
according to
Guideline:
other: EU method B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 41043/A TE
- Substance type: Red powder
- Physical state: Solid
- Storage condition of test material: At room temperature in the dark


Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg, moistened with 25 µl water

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µl Milli-Q water

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8 N
Duration of treatment / exposure:
Exposure:3 minutes and 1 hour
Details on study design:
TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 3 minutes and 1 hour


SCORING SYSTEM:
- Percentage viability: After treatment, the medium was replaced by 300 µl MTT-medium and tissues were incubated for
3 hours at 37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and formazan was extracted with 2 ml isopropanol over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 540 nm.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
98
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other:
Value:
111
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 1 hour. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Conclusions:
The in vitro skin irritation test was conducted according to OECD 431 guideline and GLP principles.

It is concluded that this test is valid and that FAT 41043/A TE is not corrosive in the in vitro skin irritation test.

Executive summary:

Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with FAT 41043/A TE compared to the negative control tissues was 98% and 111%, respectively. Because the mean relative tissue viability for FAT 41043/A TE was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment FAT 41043/A TE is considered to be not corrosive.

The positive and negative controls induced appropriate responses