[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin irritation: not irritating (EpiSkin)
Eye irritation: not irritating (EpiOcular)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The potential of the test substance to cause dermal irritation was assessed by a single topical application of 30 μL of the undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial

dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The

quotient of both values indicates the relative tissue viability. The EpiDerm skin irritation test showed the following results:

The test substance is able to reduce MTT directly. Subsequent testing of MTT reduction control was not performed, because no visible residues of the test substance remained on the tissues after washing. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 96%.

Based on the observed results and applying the evaluation criteria it was concluded, that the test substance does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.

The potential of the test substance to cause ocular irritation was assessed by a single topical application of 50 μL of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples per test run were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability.

The EpiOcular™ eye irritation test showed the following results:

The test substance is able to reduce MTT directly. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing. The mean viability of the test-substance treated tissues was 102%.

Based on the observed results for the EpiOcular Test alone and applying the evaluation criteria it was concluded, that the test substance does not show an eye irritation potential under the test conditions chosen.

Based on the results obtained from these in-vitro tests, it is concluded that the test item is neither a skin nor a eye irritant and that therefore no classification for skin or eye irritation is needed.

Justification for selection of skin irritation / corrosion endpoint:
Reliable Guideline study which is the basis for classification.

Justification for selection of eye irritation endpoint:
Reliable in-vitro study which is done with the undiluted test substance and which is the basis for classification.

Justification for classification or non-classification

The available data on skin and eye irritation does not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.