Registration Dossier
Registration Dossier
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EC number: 287-719-5 | CAS number: 85567-07-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
Skin irritation
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was 89.7 % after 60 min treatment and 42 h post-incubation, which is above the cut-off value of 50%. Hence, based on the available data on skin irritation, the test item does not meet the criteria for classification according to Regulation (EC) 1272/2008 (CLP).
Since the substance was found to be not a skin irritant, no further testing of skin corrosivity was performed.
Eye irritation
2 in vitro studies have been performed to assess the eye irritation potential of the test item: BCOP and EpiOccular assays.
In the first test, the eye irritancy potential of the test substance was investigated in the bovine corneal opacity and permeability assay (BCOP). The mean in vitro irritation score (IVIS) was calculated as 30.04. Since, for an IVIS > 3 and ≤ 55 no prediction can be made, a second eye irritation study has been performed.
In this second study, the potential of the test item to induce eye irritation was analysed by using the three-dimensional human corneal epithelium model EpiOcular. This model consists of normal, human-derived epidermal keratinocytes mimicking characteristics of the corneal epithelium. Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with Aqua dest.
The mean relative tissue viability was 2.5 %, which is below the cut-off value of 60%. The test item hence showed irritant effects.
Test results using the EpiOcular model indicate that test item is either eye irritant or inducing serious eye damage. The substance is therefore conservatively classified as eye irritant category 1 according to CLP EC No. 1272/2008.
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