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EC number: 266-380-7
CAS number: 66492-51-1
No mortality or signs of systemic toxicity were observed.
Significant increase in lymph node weight in the highest dose group (5%).
Significant increas in lymph node cell count in high and mid-dose (2.5%,
5%). Cut-off value for lymph node cell count index Balb/c mice (1.55)
exceeded in the high dose (2.39)
Significant increase in ear weight very slightly (by 0.01) exceeding
Balb/c cut-off value, but not exceeding an increase of 25%, OECD
guidance on excessive local irritation.
In this study the test item was assessed for its skin sensitising
potential using the Local Lymph Node Assay (LLNA) in mice. Test item
solution at different concentrations of 1, 2.5, and 5% were prepared in
the vehicle acetone:olive oil (4+1 v/v). The highest concentration
tested was the highest concentration that could be applied whilst
avoiding systemic toxicity and excessive local skin irritation (as
determined by three pre-experiments).
The animals did not show any signs of systemic toxicity or local skin
irritation during the course of the study and no cases of mortality were
observed. A statistically significant increase in ear weights was
observed in the high dose group in comparison to the vehicle control
group (p<0.05). Furthermore, the cutoff-value for a positive response
regarding the ear weight index of 1.1 reported for BALB/c mice (see Ref.
9) was slightly exceeded in the high dose group (index of 1.11).
However, the obtained mean value of this group was still within the
range of historical vehicle control data for the ear weight.
Furthermore, the threshold value of 25% (increase in ear weight in
comparison to the vehicle control group) for excessive local skin
irritation mentioned in OECD guideline 429 was not exceeded in this
group. Thus, this was not considered as biologically relevant.
Stimulation Indices (S.I.) of 1.18, 2.49, 6.18 were determined with the
test item at concentrations of 1, 2.5, and 5% (w/w) in acetone:olive oil
(4+1 v/v), respectively. A clear dose response was observed. Based on
the S.I.s obtained with 2.5 and 5% test item concentration, an EC3 value
of 2.8% (w/w) was calculated.
A statistically significant and biologically relevant increase in DPM
value and also in lymph node cell count was observed in the mid and high
dose group in comparison to the vehicle control group (p<0.05). A
statistically significant and biologically relevant increase in lymph
node weight was only observed in the high dose group (5%) in comparison
to the vehicle control group. Furthermore, the cutoff-value for a
positive response regarding the lymph node cell count index of 1.55
reported for BALB/c mice (see Ref. 8) was exceeded in the high dose
group, and showed a borderline response in the mid dose group (indices
of 2.39 and 1.51, respectively).
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