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Toxicological information

Skin irritation / corrosion

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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: Study was performed according to the recommended guidelines and GLP, and without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test - adopted 13 April 2004)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Human-derived epidermal keratinocytes, EpiDerm Skin Model (EPI-200, Lot no.: 4651 kit I)
Strain:
other: Human-derived epidermal keratinocytes, EpiDerm Skin Model (EPI-200, Lot no.: 4651 kit I)

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl was applied undiluted directly on top of the tissue.
DNM was spread to match the size of the tissue.
- Concentration (if solution): 100% (undiluted)
Duration of treatment / exposure:
The substance was topically applied on the skin tissue for a 3 minutes and 1 hour exposure, followed by immediate determination of the cytotoxic (corrosive) effect.
Number of animals:
Not applicable

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: absorbance (540 nm)
Basis:
mean
Time point:
other: 3 minutes
Score:
1.563
Max. score:
1.576
Reversibility:
no data
Irritation parameter:
other: absorbance (540mn)
Basis:
mean
Time point:
other: 1 hour
Score:
1.713
Max. score:
1.739
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
It is concluded that this test is valid and that the test substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
There were no deviations from guideline; validity criteria have been fulfilled.