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EC number: 429-330-7
CAS number: -
One DPM value was rejected and not used for
interpretation (extremely large lymph node and outside historical range
for vehicle control).
Assessment of Contact Hypersensitivity to
EDTN in the Mouse (Local Lymph Node Assay).
The study was carried out based on the
guidelines described in: OECD, Section 4, Health Effects, No.429 (2002),
EC, No 440/2008; B42: "Skin Sensitization: Local Lymph Node Assay" EPA,
OPPTS 870.2600 (2003) “Skin Sensitization”.
Test substance concentrations selected for
the main study were based on the results of a preliminary study.
In the main study, three groups of five
experimental animals were treated with test substance concentrations of
10, 25 or 50% w/w on three consecutive days, by open application on the
ears. Five vehicle control animals were similarly treated, but with
vehicle alone (Propylene glycol). Three days after the last exposure,
all animals were injected with 3H-methyl thymidine and after five hours
the draining (auricular) lymph nodes were excised. After precipitating
the DNA of the lymph node cells, radioactivity measurements were
The activity was expressed as the number of
Disintegrations Per Minute (DPM) and a stimulation index (SI) was
subsequently calculated for each group. No irritation of the ears was
observed in any of the animals examined. All auricular lymph nodes of
the animals of the experimental and control groups were considered
normal in size, except for one extremely enlarged lymph node in one
animal of the control group. No macroscopic abnormalities of the
surrounding area were noted.
Mean DPM/animal values for the experimental
groups treated with test substance concentrations 10, 25 and 50% were
231, 237 and 242, respectively. The mean DPM/animal value for the
vehicle control group was 212.
The SI values calculated for the substance
concentrations 10, 25 and 50% were 1.1, 1.1 and 1.1, respectively. Since
there was no indication that the test substance elicits an SI ≥ 3 when
tested up to 50% w/w, i.e. the maximum test concentration in case of a
solid, EDTN was considered not to be a skin sensitizer.
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