Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study followed the Draft Test Guideline on In Vitro Skin Irritation: Human Skin Model Test from the OECD Guidelines for testing of chemicals, and was performed in compliance with the Good Laboratory Practice (GLP) regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Qualifier:
according to
Guideline:
other: OECD 431
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Type of coverage:
other: in vitro human skin model
Preparation of test site:
other: in vitro human skin model
Amount / concentration applied:
20 mg/tissue
Duration of treatment / exposure:
1 hour
Details on study design:
The study was performed to assess the corrosive potential of the test item by means of the human skin model test. Human recostrcuted skin was topically exposed to 20 mg test item for 3 min and 1 hour followed by a cell viability test. Cell viability was measured by dehydrogenase conversion of MTT into a blue foramzan salt which was quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict skin corrosion.

Triplicates of the human skin model were treated either with the test item, negative (distilled water) or positive control (potassium hydrodide 8N). For each time point (3 min and 1 hour), 3 RHE tissues were used for test item, negative and positive controls

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: relative viability
Basis:
mean
Time point:
other: 3 min
Score:
100
Reversibility:
no data
Irritation parameter:
other: relative viability
Basis:
mean
Time point:
other: 1 hour
Score:
19.71
Reversibility:
no data
Irritant / corrosive response data:
Treatment with the positive control induced a sufficient decrease of the viability of the tissue compared to the negative control for the treatment interval thus ensuring the validity of the test system.

Applicant's summary and conclusion

Executive summary:

The aim of the study was to assess the corrosive potential of the test item in a three-dimensional human reconstituted skin model comprising a reconstructed epidermis with a functional statum corneum. The reconstituted human skin was exposed to the test material topically for 3 min and 1 hour. After exposure to the test material the effects on cell viability as a measure for corrosivity/irritancy was measured by adding MTT to the tissue. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT.

Tripicates of the human skin model were treated either with the test item, negative (distilled water) or positive (potassium hydroxide) control for 3 minutes and 1 hour. 40 µL of the negative or positive control or 20 mg of the test item were applied to each tissue.

Treatment with the positive control induced a sufficient decrease in the relaive absorbance as compared to the negative control for the treatment interval. The mean relative tissue viability after treatment (1 hour) with the test item was >15%. Therefore, the test item is not considered to possess a corrosive potential.