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EC number: 242-582-0
CAS number: 18794-84-8
Individual clinical observations and mortality data for test and control
animals are given in Table 5. There were no deaths. No signs
of systemic toxicity were noted in the test or control animals during
Individual body weights and body weight change for test and control
animals are given in Table 6.
Body weight change of the test animals between Day 1 and Day 6 was
comparable to those observed in the corresponding control group animals
over the same period.
Table 4 Individual Disintegrations per Minute and Stimulation
Mean dpm/Animal(Standard Deviation)
Acetone/olive oil 4:1
5% v/v in acetone/olive oil 4:1
10% v/v in acetone/olive oil 4:1
25% v/v in acetone/olive oil 4:1
Positive Control Item
results of the statistical analysis of the data indicated there was no
significant difference between the control group and the test groups.
number of lymph nodes per animal is 2
Index of 3.0 or greater indicates a positive result
different from control group p<0.05
Table 5 Individual Clinical Observations and Mortality Data
Vehicle acetone/olive oil 4:1
0= No signs of
Table 6 Individual Body Weights and Body Weight Change
Body Weight (g)
Body Weight Change (g)
Vehicle acetone/olive oil
Ear Thickness Measurements and Mean
Ear Thickness Changes are given in Table 7 and Local
Skin Irritation in Table 8 (see attachments).
There was no increase in ear thickness
in any of the test or control animals on Days 3 and 6. No
signs of irritation were seen in any of the animals throughout the test
Ear Weight Measurements are given in Table 9 (see attachments).
There was no increase in ear weight measurements (≥25%) in any of
the test or positive control animals on Day 6.
INTRODUCTION AND PURPOSE
A study was performed to assess the skin sensitization potential of the
test item in the CBA/Ca strain mouse following topical application to
the dorsal surface of the ear. This study was
designed to be compatible with the procedures indicated by the following
internationally accepted guidelines and recommendations:
OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitization:
Local Lymph Node Assay" (adopted 22 July 2010)
Method B42 Skin Sensitization (Local Lymph Node Assay) of Commission
Regulation (EC) No. 440/2008
United States Environmental Protection Agency Health Effects Test
Guidelines OPPTS 870.2600 Skin Sensitization March 2003
The assay has undergone extensive inter‑laboratory validation and has
been shown to reliably detect test items that are moderate to strong
Following a preliminary screening test in which no clinical signs
of toxicity were noted at a concentration of 25% v/v, this concentration
was selected as the highest dose investigated in the main test of the
Local Lymph Node Assay. Three groups, each of five animals, were treated
with 50 µL (25 µL per ear) of the test item as a solution in
acetone/olive oil 4:1at concentrations of 25%,10% or 5% v/v. A further
group of five animals was treated with acetone/olive oil 4:1alone. A
concurrent positive control test, using a group of five animals, was
also performed with the known sensitizer, α‑Hexylcinnamaldehyde tech.,
85%, at a concentration of 25% v/v in acetone/olive oil 4:1.
The Stimulation Index expressed as the mean radioactive
incorporation for each treatment group divided by the mean radioactive
incorporation of the vehicle control group are as follows:
The test item was considered to be a non- sensitizer under the
conditions of the test.
α-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater
than 3 when tested at a concentration of 25% v/v in acetone/olive oil
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