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EC number: 700-570-7
CAS number: 1217271-49-2
DPM, DPN and
Stimulation Index Values for all Groups in the Main Test
of this study was to determine the skin sensitization potential of Sika
Hardener MH following dermal exposure in the Local Lymph Node Assay
performed according to OECD 429, EU Method B.42 and OPPTS 870.2600. The
test item is a liquid, hence, the maximum concentration of 100 % (the
undiluted test item) was tested. Solubility of the test item in Acetone:
Olive oil 4:1 (v/v) mixture (AOO) was examined and found to be
acceptable. Since AOO is the most preferred solvent according to OECD
429 guideline, no other solvents were examined. The 50 % and 25 %
formulations of test item in AOO were real solutions. Applicability of
the undiluted test item and the formulations on the ears of animals was
acceptable. A preliminary irritation/toxicity test was performed showing
that application of test item up to 100 % was acceptable.
In the main assay 20 female CBA/Ca
mice were allocated to five groups of four animals each:
- three groups received Sika
Hardener MH at concentrations of 100 %, 50 % or 25 %,
- the negative control group
received the vehicle (AOO),
- the positive control groups
receiveda-Hexylcinnamaldehyde (HCA) at concentration of 25 %.
Each substance was applied on the
external surface of each ear (25 mL/ear) of the animals for three
consecutive days (Day 1, 2 and 3). There was no treatment on Days 4, 5
and 6. On Day 6, the cell proliferation in local lymph nodes was
determined by measuring incorporation of tritiated methyl thymidine
(3HTdR) and the obtained values were used to calculate stimulation
No mortality or significant systemic
clinical signs were observed during the study. In the 100 % test item
treated group twitching (intermittent) of the animals was observed
approximately 1 hour after the third treatment on Day 3, but all animals
were normal approximately 8 hours after the treatment and remained
normal (i.e. no signs of systemic toxicity observed) during the
subsequent days. No significant treatment related effects were observed
on animal body weights in any treatment groups. No cutaneous reactions
were observed at the site of the treatment (on the ears) in any of the
treated groups. Slight, but not significant erythema was observed in the
test item treated groups (presumably because of the slight accumulation
of the viscous test item) at the base of ears of animals. Slight loss of
hair (1/4 animals) was observed in the 100 % dose group. The effect was
local (on the top of the head) and not extensive. The above mentioned
effects were considered not to be significant and could not have effect
on the proliferation results.
Stimulation index values of the test item
were 31.8, 24.8 and 23.4 at treatment concentrations of 100 %, 50 % and
25 %, respectively. The stimulation index values were compatible with a
biological dose-related response.
Normally, the EC3 value (the
theoretical concentration of the test item in the test solution, leading
a three fold increase of lymph node cell proliferation over the control)
is estimated by linear interpolation using the reported SI values and
the corresponding concentrations immediately above and below the SI
value of 3. Since no SI value below 3 was observed with the test item,
no estimation of the EC3 value was performed in this LLNA.
α-Hexylcinnamaldehyde, dissolved in AOO at
concentration of 25 % (w/v) was used as positive control to demonstrate
the appropriate performance of the assay. A significant
lymphoproliferative response was noted for the positive control chemical
with a stimulation index value of 7.4. The positive control results
obtained confirmed the validity of the assay.
In conclusion, the test item SIKA Hardener
MH was determined to be skin sensitizing in the LLNA assay.
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