Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 456-350-3
CAS number: 878665-13-5
None of the mice assigned to this study
experienced visible irritation or other adverse toxic effects after
dosing. Three mice, each in a different treatment group, lost minimal
amounts of weight between randomization and lymph node harvest
(animals #11, 40, and 44 lost 0.3, 1.0, and 0.2 grams, respectively).
On Day 1 of dosing, the tail of animal #7 was found to be raw, scaly,
and inflamed. That mouse was removed from the study prior to dosing
and replaced with animal #49.
Body weights at lymph node harvest ranged
from 18.3 to 24.3 grams.
Individual and group DPM values and group
SI values appear in Tables 1 and 2, respectively (See “Tables of
results” in “background attached material”). All calculated DPM values
were used in data calculations and statistical analyses.
A substance is considered a sensitizer if
at least one concentration of the test material results in an SI value
greater than or equal to 3. The test material had an SI value greater
than 3 at the 40% concentration (SI ~ 5.3), as did isoeugenol at 5%
(SI ~ 15.5). A one-sample, one-sided Student's t test found only the
isoeugenol value statistically significant (p < 0.05). For
ANOVA and non-parametric results, the isoeugenol model had excellent
fit. Isoeugenol had a non-significant Bartlett's
Chi-Square term; therefore, parametric results are reliable. Dunnett's
test found only the 5.0% concentration of isoeugenol to be
different from vehicle. The results of the KW and Jonckheere's tests
were both significant, which confirms the parametric Dunnett's test
results. The parametric ANOVA had excellent fit for the test material
also. The Bartlett's Chi-Square term was non-significant;
therefore, parametric resuIts are reliable.Dunnett's
test found both the 20% and 40% concentrations of the test
material to be different from vehicle. The results of the KW andJonckheere's
tests were significant, confirming the parametric results and
suggesting concentration differences and a dose response or trend.
The quadratic and linear models had
excellent fit for isoeugenol, although the quadratic term was non
significant.The EC-3 (linear model) was calculated to be 0.88%
for isoeugenol. Both the quadratic and the linear model had excellent
fit for the test material. The quadratic term was not significant;
therefore the linear model is preferred. The calculated EC-3 for the
test material, 20.71%, is within the acceptable range for the
concentrations tested and is therefore considered reliable.
None of the tested mice experienced 10%
or-greater increases in ear thickness between Day 1 and Day 3, thus
there was no irritation reaction to potentially affect the LLNA
stimulation indices. Ear measurements for individual mice follow in
“Tables of results” in “background attached material".
In a dermal sensitization study performed
according to the OECD test guideline No. 429 and in compliance with
Good Laboratory Practice, the test material was tested in female CBA/J
mice using the Local Lymph Node Assay. Mice were treated daily for
three consecutive days by direct epicutaneous application of 25 µL of
test or control article to the dorsum of each ear. The test material
was tested at 1, 5, 10, 20, and 40 % final concentrations in
acetone/olive oil. The control articles included the vehicle,
acetone/olive oil (AOO), and a known sensitizer, isoeugenol.
Isoeugenol was tested at 0.5, 1.0, and 5.0 % concentrations in AOO
(4:1). The mice were observed daily. Three days after the final
auricular application, the animals were injected intravenously with
125-I labelled Iododeoxyuridine to label proliferating cells.
I-125-incorporation was quantified using a gamma counter.
A substance is considered a sensitizer if
at least one concentration of the test material results in a
stimulation index (SI) greater than or equal to 3. The test material
had an SI value greater than 3 at the 40% concentration (SI = 5.3), as
did isoeugenol at 5.0 % (SI = 15.5). Only isoeugenol at 5 % was found
to be statistically significant (p < 0.05). None of the other tested
concentrations yielded SI values greater than or equal to 3.
Mean ear thickness values, which were
taken on Days 1 and 3, did not increase by 10 % or more at any tested
concentration of either isoeugenol (0.5 %-5.0 %) or ST 48 C 03 (1 %-40
Isoeugenol, with an EC-3 of 0.88 %, is
classified as a strong sensitizer (potency value between 0.2 and 2%)
(ECHA Chapter R.8, 2010). This is consistent with previously reported
The test material, with an EC-3 of 20.71
%, is classified as a moderate sensitizer (potency value above 2%).
Under the conditions of testing, the
substance is classified as Skin Sens. 1B, H317 (May cause an allergic
skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP)
and to the GHS, based on the calculated EC3 of 20.71 % (> 2%).
Under the categorisation of chemicals
according to skin sensitisation potency using the LLNA, the substance
is a weak skin sensitiser (Potency Values from the Local Lymph Node
Assay: Application to Classification, Labelling and Risk Assessment.
ECETOC Document No. 46, December 2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again