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Description of key information

Eye irritation in vitro: not irritant

Skin irritation in vitro: not irritant

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 ocular irritation was assessed by a single topical application of 50µL of undiluted Efka-K-111 Solvent free to a reconstructed three-dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissues 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 (MTT). The mean viability of the test-substance treated tissues was 81.8%. Consequently, the test substance does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen. No further in vitro assays (BCOP) were required, since for non-irritant substances the differentiation between irritant and corrosive properties is unnecessary.

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™). The irritation test was performed with three EpiDerm™ tissues, which 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 (MTT) to measure relative viability.

The mean viability of the test-substance treated tissues was 90.1%. Positive and negative control tissues gave results within the historical control ranges.

Based on the observed results, it was concluded, that Efka-K-111 Solvent free does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions

chosen. No further test for skin corrosion is required.

Justification for classification or non-classification

Efka-K-111 was not irritant to skin or eyes in in vitro assays. No classification is required according to CLP regulation 1272/2008.

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