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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 431
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test system

Type of coverage:
open
Preparation of test site:
other: human skin modell
Vehicle:
water

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Value:
> 105
Remarks on result:
other:
Remarks:
Basis: other: photometric absorption. Time point: 1 h. Max. score: 15.0. Reversibility: no data. Remarks: if the absorption exceeds 15 %, the substance can be considered to be not corrosive. (migrated information)

Any other information on results incl. tables

All validity criteria were fulfilled; the positive control

was clearly corrosive and the OD of the negative control lay

well above 0.8.

After treatment with the test item, the relative absorbance

values were decreased to 90.4 percent after 3 min. treat-

ment. This value is well above the threshold for corrosi-

vity (50 percent). After 1 hour treatment relative absor-

bance values were increased to 105.1 percent.

This value is well above the threshold for corrosi-

vity (50 percent). After 1 hour treatment relative absor-

bance values were increased to 105.1 percent. This value

is far above the threshold for corrosivity (15 percent).

Therefore, the test item is considered as "not corrosive".

The values of the negative control were well above the

required acceptability criterion of a mean OD > 0.8 for both

treatment interval thus showing the quality of the tissues.

The value of the positive control induced a decrease in the

relative absorbance as compared to the negative control to

20.5 % for the 3 minutes treatment interval and 13.3 % for

the 1 hour treatment interval thus ensuring the validity of

the test system.

For these reasons, the result of the test is considered

valid.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
After treatment with the test item, the relative absorbance values were decreased to 90.4% after 3 min. treatment. This value is well above the threshold for corrosivity (50%). After 1 hour treatment relative absorbance values were increased to 105.1%. This value is far above the threshold for corrosivity (15%).
Therefore, the test item is considered as "not corrosive".