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EC number: 814-338-9 | CAS number: 1913285-57-0
GR-50-3010 was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that GR-50-3010
did not interfere with the MTT endpoint.
The mean absorption at 570 nm measured after treatment with GR-50-3010 and controls are presented in Appendix 2, Table 1.
Table 2 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with GR-50-3010 compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with GR-50-3010 compared to the negative control tissues was 135% and 127% respectively. Because the mean relative tissue viability for GR-50-3010 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment GR-50-3010 is considered to be not corrosive.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit 2.8) and the laboratory historical control data range. The mean relative tissue viability following the 1-hour exposure to the positive control was 9%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was 2.3%, indicating that the test system functioned properly.
In vitro skin irritation test with GR-50-3010 using a human skin model.
This report describes the ability of GR-50-3010 to induce skin irritation on a human three
dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM)). The possible skin
irritation potential of GR-50-3010 was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC
Batch VE00466805 of GR-50-3010 was a colourless to very slightly yellow liquid.
GR-50-3010 was applied undiluted (25 μl), directly on top of the skin tissue for
15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic
(irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial
dehydrogenase activity measured by formazan production from MTT at the end of the
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The
relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with GR-50-3010
compared to the negative control tissues was 4.5%. Since the mean relative tissue viability for
GR-50-3010 was below or equal to 50% after 15 ± 0.5 minutes treatment it is considered to
The positive control had a mean cell viability of 11% after 15 ± 0.5 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 3%, indicating that the test systemfunctioned properly.
GR-50-3010 induced ocular irritation through both endpoints, resulting in a mean in vitro
irritancy score of 11 after 10 minutes of treatment. This is insufficient to classify as Cat 1 based on GHS criteria and is well below the classification threshold. It is also above the threshoold for non-classification. Therefore the substance has been classified as Cat 2 irritant to the eye which is considered sufficiently protective based on current evidence and avoids the need for additional animal data.
GR 50 -3010 was irritating in vitro skin assay but not corrosive leading to recommendation to classify irritant to the skin.
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