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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)
Rationale for reliability incl. deficiencies:
other: study was preformed according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 431 Determination "In vitro Skin Corrosion: Human Skin Model Test"
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Human Skin Model EpiDerm TM
Strain:
other: normal , human derived epidermal keratinocytes

Test system

Type of coverage:
other: Human Skin Model EpiDerm TM
Preparation of test site:
other: Human Skin Model EpiDerm TM
Vehicle:
water
Controls:
other: Human Skin Model EpiDerm TM
Duration of treatment / exposure:
3 min and 1 h

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
> 1.75 - < 1.76
Remarks on result:
other:
Remarks:
Basis: other: Human Skin Model EpiDerm TM. Time point: 3 min. Reversibility: no data. (migrated information)
Irritation / corrosion parameter:
other:
Value:
> 1.66 - < 1.67
Remarks on result:
other:
Remarks:
Basis: other: Human Skin Model EpiDerm TM. Time point: 1h. (migrated information)

Any other information on results incl. tables

One valid experiment was performed.

Two tissues of the human skin model EpiDermTMwere treated with Cyanamide, lead(2+) salt (1:1)

for three minutes and one hour, respectively.

25 mg of the solid test item were applied to each tissue and spread to match the tissue size.

Deionised water was used as negative control, 8m 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. The positive control showed clear corrosive effects for both treatment intervals.

After three minutes treatment with the test item, the relative absorbance values were reduced to 97.6 %. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were reduced to 95.0 %. This value, too, is well above the threshold for corrosion potential (15%).

Therefore, Cyanamide, lead(2+) salt (1:1)

considered as not corrosive in the Human Skin Model Test.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The presented data are reliable and adequate.
Executive summary:

The test item is considered not corrosive.

After three minutes treatment, the relative absorbance values were decreased to 97.6%. This value is well above the threshold for corrosivity (50%). After one hour treatment relative absorbance values were reduced to 95.0%. This value is well above the threshold for corrosivity (15%).

 

The values of the negative control were well above the required acceptability criterion of 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 28.2% for the three minutes treatment interval and 12.2% for the one hour treatment interval thus ensuring the validity of the test system.

 

For these reasons, the result of the test is considered valid.