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EC number: 947-313-7
CAS number: -
7.3.1/1: Main test - Individual and mean OD values and tissue
viabilities for the test item, the negative and positive controls
Mean OD / disc
Mean OD / product
mean of 3 values (triplicate of the same extract)
An in vitro skin irritation study was
performed according to the OECD Guideline 439 and in compliance with
GLP, using the SkinEthic reconstructed human epidermis model.
The test item was administered as supplied,
at the dose of 16µl, to 3 living Reconstructed Human epidermis
(SkinEthic RHE® model) during 42 minutes. The application was followed
by a rinse with 25 mL of DPBS and a 41 hours 15 minutes post-incubation
period at 37°C, 5% CO2. Cell viability was then measured by enzymatic
conversion of the vital dye MTT into a blue formazan salt that was
quantitatively measured after extraction from tissues.
The mean percent viability of the treated
tissues was 3.6%, versus 1.6% in the positive control (5% Sodium Dodecyl
Concerning acceptability criteria:
- The negative control OD of the 3
replicates is > 0.4 and < 1.5 (values between 0.573 and 0.860).
- The SD values of the % viability are ≤ 18%
(values between 0.1 and 16.7%).
- The positive control is classified as
- The 3 replicates of the test item gave
The quality criteria required for acceptance
of results in the test were satisfied.
The positive control OD were within the
historical control range. The negative control OD of one of the
replicate were below the historical control range. However, this
deviation is not considered to have affected the integrity of the study
or the overall conclusion.
Under the experimental conditions of this
study, in the absence of information on skin corrosion, the test
substance has to be classified in Category 2 "Irritating to skin" or
Category 1 "Corrosive" according to Regulation (EC) No. 1272/2008 (CLP)
and to the GHS.
This study is considered as acceptable and
satisfies the requirement for skin irritation endpoint.
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