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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to EU Method B.46 resp. OECD 439 Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): CAS No. 135452-43-6

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
0.999
Remarks on result:
other:
Remarks:
Basis: other: % Formazan production (Tissue 1). Time point: 60 minutes. Remarks: relative absorbance value: 99.9%. . (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.987
Remarks on result:
other:
Remarks:
Basis: other: % Formazan production (Tissue 2). Time point: 60 minutes. Remarks: relative absorbance value: 98.7%. . (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.97
Remarks on result:
other:
Remarks:
Basis: other: % FOrmazan production (Tissue 2). Time point: 60 minutes. Remarks: relative absorbance value: 97.0%.. (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.985
Remarks on result:
other:
Remarks:
Basis: other: % Formazan production Mean. Time point: 60 Minutes. Remarks: relative absorbance value: 98.5%. . (migrated information)

Any other information on results incl. tables

After the treatment with the test item, the relative absorbance values were reduced to 98.5%. This value is well above the threshold for irritation potential (50%).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is considered as not irritant in the Human Skin Model Test.