Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 431, adopted 13. Apr. 2004 (In vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Details on test animals and environmental conditions:
in vitro test
no animals

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified

Results and discussion

Any other information on results incl. tables

After three minutes treatment with the test item, the relative absorbance values were reduced to 77.9 %. This value is well above the threshold for corrosivity (50 %).

After one hour treatment with the test item, the relative absorbance values were reduced to 63.0 %, again laying well above the threshold for corrosivity (15 %).

Therefore, the test item B 1061 is considered as not corrosive.

The negative control was within the normal range (criterion OD > 0.8), showing an OD of 2.092.

The positive control showed a clear corrosive effect in both experiments.The value of the three-minute-experiment is 23.2 % and the value of the one-hour-experiment is 11.3 %. Therefore, the test is considered valid.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test item B 1061 is considered as not corrosive in the Human Skin Model Test.
Executive summary:

One valid experiment was performed.

Two tissues of the human skin model EpiDermTM were treated wiht for three minutes and one hour, respectively.50 µl of the test item were applied to each tissue and spread to match the tissue size.

Deionised water was used as negative control, 8 -m KOH was used as positive control.

After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues.

After treatment with the test item, the relative absorbance values were decreased to 77.9 % after three minutes treatment. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 63 %. This value, too, is well above the threshold for corrosion potential (15 %).

Therefore, the test item B 1061 is considered as not corrosive in the Human Skin Model Test.