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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed to EU guidelines

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: compact
Details on test material:
As the substnace is normally supplied in water as 30 - 40 % solution, material was dried specifically for testing.

Test animals

Details on test animals and environmental conditions:
In vitro study

Test system

Details on study design:
The principle of the assay is based on the measurement of cytotoxicity in reconstructed
human epidermal cultures following topical exposure to the test item by means of the
colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of
the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium
bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test item
treated tissues relative to the negative controls.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Basis: other: In-vitro. Remarks: In-vitro testing. (migrated information)

In vivo

Irritant / corrosive response data:
The relative mean viability of the test item treated tissues was 112.6% after a 15-Minute exposure period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The relative mean viability of the test item treated tissues was 112.6% after a 15-Minute exposure period and is not considered to be irritant to skin accordign to GHS criteria
Executive summary:

In view of the reported results being below thresholds for classification as irritant, it is considered unlikely that the diluted material manufactured and supplied (30 - 40% in water) will be irritating to skin.

It is not considered necessary to perform in-vivo testing on this substance in its concentrated form.