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EC number: 268-452-3 | CAS number: 68092-28-4
Direct MTT Reduction
An assessment found that the test material was able to directly reduce MTT. Therefore, an additional procedure using water-killed tissues was performed during the determination of skin irritation potential. However, the results obtained showed that a negligible degree of interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the water-killed tissues for quantitative correction of results or for reporting purposes.
-The relative mean tissue viability for the positive control treated tissues was 8.9 % relative to the negative control treated tissues and the standard deviation value of the percentage viability was 1.9 %. The positive control acceptance criterion was therefore satisfied.
-The mean OD540 for the negative control treated tissues was 0.774 and the standard deviation value of the percentage viability was 15.0 %. The negative control acceptance criterion was therefore satisfied.
-The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 2.1 %. The test material acceptance criterion was therefore satisfied.
Table 1 Mean OD540 Values and Percentage Viabilities for the Negative and Positive Controls and the Test Material
OD540 of Tissues
Mean OD540 of Triplicate Tissues
± SD of OD540
Relative Individual Tissue Viability (%)
Relative Mean Viability (%)
± SD of Relative Mean Viability (%)
*The mean viability of the control group is set at 100 %
SD = Standard deviation
The skin irritation potential of the test material was evaluated in vitro using the EPISKIN reconstructed human epidermis model in accordance with the standardised guidelines OECD 439 and EU Method B.46 under GLP conditions.
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period, each tissue was rinsed before being incubated for 42 hours, after which each tissue was taken for MTT loading. After MTT loading, a total biopsy of each epidermis was made and formazan crystals were extracted out of the MTT-loaded tissues. Duplicate tissues treated with Dulbecco’s Phosphate Buffered Saline with Ca++ and Mg++ served as the negative control and duplicate tissues treated with 5 % w/v aqueous Sodium Dodecyl Sulphate served as the positive control. The optical density of all treated tissues was measured at 540 nm.
The relative mean viability of the test material treated tissues was 10.2 % after the 15 minute exposure period.
Under the conditions of this study, the test material was determined to be a Category 2 irritant in accordance with the criteria set out in Annex I of Regulation (EC) No 1272/2008 (CLP). It also classified as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
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