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EC number: 203-885-3 | CAS number: 111-59-1
Skin irritation: In the OECD 439 study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Eye irritation: The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated to 0.93. Therefore the test item was classified into UN GHS No Category.
The mixture of 30 µL test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%. The mixture of 30 µL of the test item per 300 µL aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.
Table 1: Result of the Test Item
mean OD570 of the duplicates (blank-corrected)
total mean OD570 of 3 replicate tissues (blank-corrected)
SD tissue viability [%]***
* Blank-corrected mean OD570 nm of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is <= 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (113.3%) after 60 min treatment and 42 h post-incubation. The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was >= 0.8 and ≤ 2.8. The mean relative tissue viability (% negative control) of the positive control was <= 20% (3.8%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.8% - 8.0%).
In the in vitro skin irritation study (OECD 439) under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated to 0.93. Therefore the test item was classified into UN GHS No Category.
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