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EC number: 700-597-4
CAS number: 1215841-86-3
Main study results: stimulation indices (SI):
Group 1, negative control
Group 3, 25%
Group 4, 50%
Lymph node cell count
Lymph node weight
- significantly different from control at p ≤ 0.01
The purpose of this study was to
determine the sensitising potential of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide
in the local lymph node assay in
The study was performed according to
OECD 429, however not employing the use of radioactive labelling to
measure cell proliferation, as the radioactive method proposed by the
OECD guideline led to problems in various EU laboratories: such as (i)
practical difficulties/complexity of the test, in particular the
radiochemical steps, which sometimes resulted in loss of
specimen/activity; this in turn led to variability in the results and to
a poor reproducibility and (ii) radiation protection issues. However,
the OECD guideline allows other endpoints for assessment of
proliferation in form of lymph node cell counts and lymph
node weights if justification
and appropriate scientific support exist showing the validity of this
The alternative method used for the study employing the lymph
node weight and lymph
node cell count to assess proliferation
has been established by an European interlaboratory
validation exercise, as described in the two publications by Ehling et
al. 2005a and 2005b.This method has the advantage of (i) more simplistic
experimental work, (ii) less variability, (iii) better reproducibility
(iv) faster results, (v) reduced costs.
In addition, the acute inflammatory skin reaction is measured by ear
weight determination of circular biopsies of the ears and ear
thickness measurements on test day 1 and test day 4 to identify skin
irritation properties of the test item. It is important to determine if
a positive test result is due to the skin irritation potential of the
test item or due to its sensitising properties.
Stimulation indices were calculated for the lymph node cell count,
lymph node weight, ear weight and ear thickness by dividing the average
values per group of the test item treated animals by the vehicle treated
Values above 1.4 (lymph nodecell
count to identify sensitisation) or 1.1 (ear weight to identify
irritation) are considered positive (these values were fixed empirically
during the inter-laboratory validation of this method (Ehling et al.
2005a and 2005b).
Three concentrations of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide
(10%, 25% and 50%, w/w) suspended in dimethyl sulfoxide were
tested in six female NMRI mice per group and compared to a vehicle
control group. In addition, a positive control group (25%
solution (v/v) of a-hexyl
cinnamic aldehyde inacetone/olive oil (3+1, v/v))
Stimulation indices (SI):
different from control at p ≤ 0.01
Treatment with trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide
concentrations of 10%, 25% or 50% did not reveal statistical
significantly increased values for lymph node cell
count and lymph node weight. The stimulation indices of the lymph node
cell count did not exceed the threshold level of 1.4. Hence, the test
item is classified as not sensitising.
The threshold level for the ear weight
of 1.1 was not exceeded and the lymph node weights were not increased,
i.e. no irritating properties were noted.
The positive control group caused the expected increases in lymph
node cell countand lymph node
weight (statistically significant at p ≤ 0.01).Therefore,
the study could be regarded as valid.
No signs of local or systemic
intolerance were recorded. The animal body weight was not affected by
In conclusion, under the present test conditions, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide
at concentrations of 10%, 25% or 50% (w/w) in dimethyl sulfoxide did not
reveal any sensitising properties in the local lymph node assay.
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