Registration Dossier
Registration Dossier
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EC number: 435-360-1 | CAS number: 144447-11-0
Endpoint summary
Administrative data
Description of key information
It is concluded that this test is valid and that Epoxyhexmes is non-irritant in the in vitro skin irritation test. Epoxyhexmes is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
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)
Additional information
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Epoxyhexmes compared to the negative control tissues was 99%. Since the mean relative tissue viability for Epoxyhexmes was above 50% after 15 minutes treatment Epoxyhexmes is considered to be non-irritant.
The positive control had a mean cell viability of 5% after 15 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 4%, indicating that the test system functioned properly.
In the BCOP the negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.The meanin vitroirritancy score of the positive control (20% (w/v) Imidazole) was 103 and within the historical positive controldata range.It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Epoxyhexmes did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.2 after 240 minutes of treatment.
Justification for classification or non-classification
Both skin irritation and eye irritation/corrosion studies were negative. Therefore the substance is not classified for those endpoints.
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