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EC number: 946-101-1
CAS number: -
A study was conducted to determine the in
vitro skin irritation potential of the test substance according to OECD
Guideline 439 and EU Method B.46 (Reconstructed Human Epidermis Test
Method), in compliance with GLP. Human three dimensional epidermal
models (triplicates) were exposed to 25µL test substance for 15 min.
After a 42 hour post-incubation period, a determination of the cytotoxic
(irritancy) effect was performed. Cytotoxicity was expressed as the
reduction of mitochondrial dehydrogenase activity measured by formazan
production from MTT at the end of the treatment. Skin irritation was
expressed as the remaining cell viability after exposure to the test
substance. The positive control (25 µL 0.5% SDS) had a mean cell
viability of 5.3% after 15 ± 0.5 minutes exposure. The absolute mean
OD570 (optical density at 570 nm) of the negative control (25 µL PBS)
tissues was within the laboratory historical control data range. The
relative mean tissue viability obtained after 15 ± 0.5 minutes treatment
with the test substance compared to the negative control tissues was
99%. The standard deviation value of the percentage viability of three
tissues treated identically was less than 16%, indicating that the test
system functioned properly. Th experiment was considered valid. Since
the mean relative tissue viability for the test substance was above 50%
after 15 ± 0.5 minutes treatment, the test substance was considered to
be non-irritant to human skin under the study conditions (Eurlings,
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