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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:
24-aug-2009 to 28-aug-2009
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:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guideline no. 431 (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): Diformal
- Substance type: Clear yellowish liquid
- Physical state: Liquid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark under nitrogen


Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
- 3 minutes and 1 hour exposure times
Details on study design:
TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2

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

SCORING SYSTEM:
- Percentage viability

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Percentage viability
Basis:
other: Percentage of control
Time point:
other: 3 minutes
Score:
98
Irritation parameter:
other: Percentage viability
Basis:
other: Percentage of control
Time point:
other: 1 hour
Score:
86

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The positive control had a mean relative tissue viability of 7% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 15% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 8%, indicating that the test system functioned properly.

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 Diformal compared to the negative control tissues was 98% and 86%, respectively. Because the mean relative tissue viability for Diformal was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Diformal is considered to be not corrosive.

Finally, it is concluded that this test is valid and that Diformal is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.