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EC number: 604-162-9
CAS number: 13977-65-6
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
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
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
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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