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: 944-817-9
CAS number: 244626-73-1
7.4.1/1: DPM measurements
Treatment (% of test material)
N° of animal
Standard error of the mean
AOO= Acetone- Olive Oil (4:1) = vehicle
7.4.1/2: Stimulation Index Following Exposure to
Test & Control Material
Mean Stimulation Index (SI)
Isoeugenol 0.5 %
Isoeugenol 1.0 %
Isoeugenol 5.0 %
A study was performed to assess the
skin sensitisation potential of test material in the CBA/J Hsb strain
mouse following topical application to the dorsal surface of the ear.
The method was performed in compliance with GLP and similarly to the
OECD test guideline No. 429 although conducted one year before its
Five groups, each of five animals,
were treated for three consecutive days with 50 µL (25 µL per ear) of
the test item as a solution in acetone/olive oil 4:1 at concentrations
of 20, 10, 5, 2.5 or 1.0%. A further group of six animals was treated
with acetone/olive oil 4:1 alone. Three concurrent positive control
groups, using five animals each, were also performed with the known
sensitizer, Isoeugenol at concentration of 0.5, 1 or 5% w/w
acetone/olive oil 4:1. 25%
The proliferative response of the
lymph node cells (LNC) from the draining auricular lymph nodes was
assessed five days following the initial application, by measurement of
the incorporation of 25 I- Iododeoxyuridine.
Stimulation index for 20, 10, 5, 2.5
or 1.0%. in acetone/olive oil 4:1 were 1.0, 1.9, 1.2, 1.4 and 2.7,
respectively. No sign of systemic toxicity or excessive local skin
irritation were noted at the concentrations of 10%, 5% or 2.5 w/w.
The 5% concentration of isoeugenol
resulted in a group SI greater than 3. Statistical analysis (one-sample
t tests) showed this SI value was statistically significantly greater
than 3.0 (p ≤ 0.05). The 1% concentration had an SI of 4.3. This
concentration is normally considered non-sensitizing. Statistical
analysis of the 1% concentration showed that this SI = 4.3 was not
statistically significantly greater than 3. For isoeugenol with an EC-3
of 0.64%, the EC-3 potency value was calculated to be 160 µg/cm², thus,
demonstrating the sensitivity and reliability of the test system.
Under the test conditions, the test
material is not classified as skin sensitizer according to the
Regulation (EC) No. 1272/2008.
In this study, the maximum concentration
tested was not justified: a screening study was not performed and ear
thickness measurements were not included. However, the substance being a
skin irritant, it probably could not be tested at higher concentrations.
Nevertheless, this study was used within a weight-of-evidence approach
to support the absence of skin sensitisation properties of the substance.
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.
Šajā tīmekļa vietnē tiek izmantoti sīkfaili, lai nodrošinātu Jums vislabāko lietojumu mūsu tīmekļa vietnēs.
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