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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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: other: percentage viability
Value:
98
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other: other: percentage viability
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 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 compared to the negative control tissues was 98 % and 111 %, respectively. Because the mean relative tissue viability for FAT 41043/A was not below 50 % after the 3-minute treatment and not below 15 % after the 1-hour treatment FAT 41043/A is considered to be not corrosive. The positive and negative controls induced appropriate responses.