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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline available
Principles of method if other than guideline:
The test consists of a topical exposure of the neat test itmto a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [3,4,5.dimethyl thiazole 2-yl) 2,5-diphenyl-tetrazoliumbromide], present in cell mnithocondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential.
GLP compliance:
yes (incl. QA statement)

Test material


Test animals

other: tissues of the human skin model EPISKIN-SM

Test system

Type of coverage:
unchanged (no vehicle)
Duration of treatment / exposure:
15 min

Results and discussion

Any other information on results incl. tables

This in vitro study was performed to assess the irritation potential of GR-86 -2406 by means of the Human Skin Model Test.

Three tissues of the human skin model EPISKIN-SM were treated with either the test item, the negative or the positive control for 15min.

15microL of the liquid test item were applied it each tissue, spread to match the tissue size.

15microL of either the negative control (deionised water) or the positive control (5% Sodium Lauryl Sulfate) were applied to each tissue.

After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD>=0.6 for the 15min treatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a suffucuent decrease in the relative absorbance as compared to the negative control for 15 min treatment interval thus ensuring the validity of the test system.

After treatment with the test item GR-86 -2406 the relative absorbance values were not decrease relevantly. Therefore the test item is not considered to possess an irritant potential.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item GR-86 -2406 is not irritant to skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU