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EC number: 700-323-3
CAS number: 908020-52-0
The skin sensitising properties of EEA-NH4
were determined in a GLP study according OECD guideline 429 (Local Lymph Node
Assay (LLNA)) and EU method B.42 (TNO Quality of Life, 2008). For this
purpose, three groups of 5 animals each were treated with increasing
concentrations of EEA-NH4 (10%, 25% and 50% in vehicle (w/v),
respectively) applied on the dorsum of both ears (25 µL per ear) for
three consecutive days. Three days after the last treatment, all animals
received an intravenous injection of3H‑thymidine. Five hours
later, the3H-thymidine incorporation in the draining
auricular lymph nodes was determined. The results were compared with
those of a control group which was treated with the vehicle
(acetone/olive oil, 4:1 v/v). A positive control group treated with
Hexyl Cinnamic Aldehyde (a 25% HCA solution in vehicle) was included in
the study as a reliability check.
No signs of irritation were observed
after application of a 10%, 25% and 50% concentration of EEA-NH4.
incorporation in the auricular lymph nodes in animals treated with a 10%
concentration EEA-NH4 was similar to that in vehicle control animals,
was statistically significantly enhanced at 25% and 50% concentrations.
Stimulation indices (SI’s) of 1.1, 2.2 and 1.9 were calculated in
response to a 10%, 25% and 50% EEA-NH4 concentration respectively. Since
the SI’s were lower than 3 at all concentrations the results indicted
that EEA-NH4 should not be considered a skin sensitiser (a SI of 3 is
the limiting value required for classification as a skin sensitiser).
No signs of irritation were observed
after three consecutive applications of a 25% concentration of HCAin
all animals.3H-thymidine incorporation in the auricular
lymph nodes was statistically significantly enhanced in comparison with
the vehicle controls. The calculated stimulation index of 4.0 supported
this observation and demonstrated the sensitivity of the test system and
validity of the model.
Under the experimental conditions of the
available LLNA, stimulation indices of 1.1, 2.2 and 1.9 were observed
for the3H-thymidine incorporation in the auricular lymph
nodes of animals treated with 10, 25 and 50% concentrations of EEA-NH4
(w/v), respectively. Although the two highest concentrations reached statistically
significant values compared to the control, the stimulation
indices were all below a 3-fold increase in3H-thymidine
incorporation, the limiting value required for classification as a skin
sensitiser. Therefore EEA-NH4 is considered not to have skin sensitising
activity when applied at concentrations up to the highest feasible
concentration of 50%.
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