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EC number: 221-117-5
CAS number: 3007-53-2
Findings of the EpiOcular Test
Individual and mean OD570 values, individual and mean viability values
and inter-tissue variability
mean and variability [%]
viability [% of NC]
Due to the ability of the test substance to reduce MTT directly, a
KC was applied in parallel. However, the result of the KC did not
indicate an increased MTT reduction (difference to KC of NC is not
greater than 0.1; see section3.6.8). Thus the KC was not used for
Decision criteria for the combined assessment of BCOP and EpiOcular
result (see also EpiOcular Test)
The potential of N,N Dimethyldodecane-1-amide to cause ocular irritation
was assessed by a single topical application of 50 μL of the undiluted
test substance to a reconstructed three dimensional human cornea model
Two EpiOcular™ tissue samples were incubated with the test substance for 30
minutes followed by a 2-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of
the tissue after exposure/post-incubation using a colorimetric test. The
reduction of mitochondrial dehydrogenase activity, measured by reduced
formazan production after incubation with a tetrazolium salt (MTT) was
chosen as endpoint. The formazan production of the testsubstance treated
epidermal tissues is compared to that of negative control tissues. The quotient
of the values indicates the relative tissue viability.
The EpiOcular™ eye irritation test showed the following results:
The test substance is able to reduce MTT directly. However, this ability
of direct MTT reduction did not impair the study result as demonstrated
by the concurrently performed exposure of control tissues inactivated by
freezing. The mean viability of the test-substance treated tissues was
30%. Based on the observed results it was concluded, that N,N
Dimethyldodecane-1-amide shows an eye irritation potential in the EpiOcular™
eye irritation test under the test conditions chosen.
The result of the single EpiOcular does not exclude an severe irritation
potential of the test substance. For final assignment of a risk phrase
at present, results from another study would be needed. Therefore a BCOP
test was performed to receive additional information about the irritancy
of the substance. Both results were used as a combined testing strategy
(see endpointsummary for combined explaination).
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