(4Z)-hept-4-en-2-yl salicylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The test consists of a topical exposure of the neat test item to 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 material information

Constituent 1

Reference substance name:

(4Z)-hept-4-en-2-yl salicylate

EC Number:

700-488-1

Cas Number:

873888-84-7

Molecular formula:

C14H18O3

IUPAC Name:

(4Z)-hept-4-en-2-yl salicylate

Test animals

Species:

other: tissue of skin model EpiSkin

Test system

Type of coverage:

open

Vehicle:

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 potential of Gr-86 -3792 by means of the Human Skin Model Test.

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

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

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

After treatment with the test item GR-86 -3792 the relative absorbance valuees were decreased to 88.2%. This value is well above above the threshold for irritancy of <= 50%.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 -3792 is non irritant to skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU