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EC number: 915-179-9 | CAS number: -
Table 2. Preliminary test
Table 3. Main test
The potential of the test item Potassium phosphonate KH2PO3/KHPO3 to be irritant to the skin was investigated through anin vitroskin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKINTM. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 439.
The test item, as well as controls, were tested for their ability to impair cell viability after an exposure period of 15 minutes followed by a 42 hour recovery period.The final endpoint of the assay is the colorimetric measurement of MTT reduction (blue formazan salt) in the test system being this reaction an index of cell viability.
Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of the test item with the test system. In particular, the test item was assayed for the ability of reducing MTT and colouring waterper se.
No interaction was recorded between the test item and MTT in test conditions similar to those of the Main Assay. Moreover, no colouring potential of the test item in contact with water was recorded. Thus, no additional control was added in the main phase for the evaluation of non specific colour generation which may influence evaluation of results.
In the Main Assay,the test item was applied as supplied in three replicates at the treatment level of 20mL/epidermisunit, each measuring 0.38 cm2(treatment level: 53mL/cm2).
Positive and negative controls [a 5% (w/v) sodium dodecyl sulphate solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in the same number of replicates and test conditions at the treatment level of 20mL/epidermisunit.
The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the mean value is considered the baseline value of the experiment and thus represents 100% of cell viability.
The positive control caused the expected cell death (4.3% of cell viability when compared to the negative control) and variability (SD of % viability equal to 0.5).
Based on the stated criteria: mean viability ≤ 40% and SD of % viability ≤ 18, the assay was regarded as valid.
The test item did not induce cell death in any replicate with a mean cell viability of 92.1% when compared to the negative control. Intra-replicate variability was acceptable with a SD of % viability value equal to 5.2 (lower than 18).
Based on the results obtained, the test itemPotassium phosphonate – Multicomponentis classified as not irritant to the skin.
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