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EC number: 807-889-1 | CAS number: 1255203-42-9
D-C16 is non-irritant in the in vitro Episkin skin irritation test.D-C16 did not induce ocular irritation in a BCOP test inducing an IVIS ≤ 3; therefore, no classification is required for eye irritation or serious eye damage.
The study describes the ability of D-C16 to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SM TM )). The possible skin irritation potential of D-C16 was tested through topical application for 15 minutes. The study procedures described in this report were based on the most recent OECD and EC guidelines.
Skin tissue was moistened with 5 µL of Milli-Q water and an excessive amount of D-C16 was applied 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 treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with D-C16 compared to the negative control tissues was 106%. Since the mean relative tissue viability for D-C16 was above 50% after 15 ± 0.5 minutes treatment D-C16 is considered to be non-irritant.
The positive control had a mean cell viability of 44% after 15 ± 0.5 minutes exposure. The absolute mean OD 570 (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 with positive control was 27%, which was due to one outlier. However, since the other 2 viabilities were clearly positive and within the historical data range and furthermore the test substance showed a clearly negative result this did not affect study integrity. The standard deviation value of the percentage viability of three tissues treated identically with negative control or test substance was less than 8%.
Finally, it is concluded that this test is valid and that D-C16 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
Summary of opacity, permeability and in vitro scores
Mean In vitro Irritation Score*
* Calculated using the negative control mean opacity and mean permeability values. In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Evaluation of the eye hazard potential of D-C16 was performed using the Bovine Corneal Opacity and Permeability test (BCOP test, OECD 429). The report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of D-C16 was tested through topical application for approximately 240 minutes.
Batch 14-002 of D-C16 was a white crystal with a purity of 99.3%. Since no workable suspension in physiological saline could be obtained, the test substance was used as delivered and added pure on top of the corneas (321.7 to 358.4 mg).
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 135 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
D-C16 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.5 after 240 minutes of treatment. Since D-C16 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
D-C16 was tested for skin and eye irritation/damage in two in vitro tests:
In an Episkin model test no signs of irritation by the test substance were observed and thus the substance is not considered a skin irritatnt. Furthermore, in a BCOP test for eye irritation/damage, no irritation was noted and thus the substance is also not considered being an eye irritant.
As D-C16 neither induced skin nor eye irritation in two in vitro tests (Episkin and BCOP) the substance is not subject to classification and labelling for skin or eye irritation according to CLP (Regulation EC No 1272/2008).
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