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EC number: 700-071-4
CAS number: 932742-30-8
clinical signs and mortality:
No mortality or signs of systemic toxicity
were observed during the study. No significant effects were observed on
animal body weights. No irritation or other cutaneous effect was
observed in any of the groups treated.
The aim of this study was to determine the
skin sensitisation potential of SIKA Hardener LI following dermal
exposure in the Local Lymph Node Assay. The assay was performed with
CBNCa Ola Hsd female mice according to the OECD guideline 429 and the
Commission Directive 2004/73/EC, method B.42. Vehicle compatibility was
verified in a preliminary test with Acetone: Olive oil 4:1 mixture
(AOO), in which the test item was completely miscible. A preliminary
irritation toxicity test was performed with the test item at
concentrations of 100 % (the undiluted test item) and 50 % (%w/v) in the
In the main assay sixteen female CBN Ca mice
were allocated to four groups of four animals each: Three groups
received the appropriate formulation of SIKA Hardener LI at
concentrations of 100 %, 50 % or 25 %, and the negative control group
received the vehicle (AOO). Each concentration was applied on the
external surface of each ear (25 µL/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 the local lymph nodes was
measured by incorporation of tritiated methyl thymidine. Obtained values
were used to calculate stimulation indices (SI).
No mortality or systemic clinical signs were
observed during the study. No treatment related effect on the body
weights was observed. No signs of irritation or other cutaneous effect
were observed in any of the treated groups.
A significant lymphoproliferative response
(SI > 3) was noted for SIKA Hardener LI at all of the applied
concentrations. The stimulation index values (SI) were 6.2, 4.8 and 4.1
at concentrations of 100 %, 50 % and 25 %, respectively. The stimulation
index values obtained were compatible with the conventional biological
dose-response. An EC3 value was extrapolated from the data according to
Annex IV of the Updated ICCVAM-Recommended Protocol. A value of 8.4 %
was extrapolated from the raw data. The result of the latest reliability
check was used to demonstrate the appropriate performance of the assay
in accordance with the OECD guideline 429. The result with the positive
control substance a-Hexylcinnamaldehyde (HCA) confirmed the validity of
the LLNA in this laboratory.
It was concluded that under the conditions
of the present test, SIKA Hardener LI has a sensitisation potential
(sensitiser) in the Local Lymph Node Assay.
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