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EC number: 915-730-3
CAS number: -
Table 1 EPISKIN Results Repeat Study
Tissue viability as percentage of mean OD negative
Prediction MTT endpoint
Mean ± SD
100.0 ± 1.4
19.9 ± 8.2
IFF TM 09 -221
48.8 ± 9.2
As the mean tissue viability was less than 50% of the negative control
value in the repeat study (48.8% +/- 9.2%), it was decided to classify
the test-substance conservatively as Irritant R38 (EU DSD) / Irritant
H315 (EU CLP) and not to run another repeat study.
Table 2 EPISKIN Results Original Study
100.0 ± 13.8
12.0 ± 1.7
55.0 ± 4.8
As the tissue viability of 55.0% was a borderline result in the range
45-55%, it was proposed to repeat the test in a further study, although
the OECD guideline does not have an absolute requirement for a repeat
The mean Optical Density (OD) for the 6 replicate blanks was subtracted
from the individual substance and control tissues OD.
The viability of each tissue was expressed as a percentage of the mean
negative control value.
Assay acceptance criteria
The OD from the negative control tissue in the MTT assay is an indicator
of tissue viability after the shipping and storage procedure and under
the specific conditions of the assay. The mean absorbance of the
triplicate negative control values should be >=0.6 and the Standard
Deviation (SD) value of the % viability should be ≤18. The OD of the
positive control is an indicator of the sensitivity of the tissues. The
mean viability should be ≤30% of the negative control and the SD ≤18.
Data interpretation - Prediction model
If the mean tissue viability was less than 50% of the negative control
value, the sample was classed as Irritant
If the mean tissue viability was greater than 50% of the negative
control value, the sample was classed as non-irritant.
An in vitro skin irritation study was performed in accordance with
OECD 439. As the tissue viability presented borderline result in the
range 45 -55%, with a mean of 48% tissue viability. In a second test the
mean tissue viability was 55%. A conservative approach has been taken
and result in the substance being a skin irritant.
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