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EC number: 201-114-5
CAS number: 78-40-0
no evidence of skin sensitization in a GLP and Guideline compliant LLNA
The proliferation response of lymph node cells was expressed as the
number of radioactive disintegrations per minute per lymph nodes from
each individual animal and as the ratio of 3HTdR incorporation into
lymph node cells of test nodes relative to that recorded for the control
nodes (Stimulation Index). The test material will be regarded as a
sensitiser if at least one concentration of the test material results in
a threefold or greater increase in 3HTdR incorporation compared to
control values. Any test material failing to produce a threefold or
greater increase in 3HTdR incorporation will be classified as a
A study was perfonned to assess the skin sensitisation potential of the
test material in the CBA/Ca strain mouse following topical application
to the dorsal surface of the ear. The method was designed to meet the
requirements ofthe following:
• OECD Guideline for the Testing of Chemicals No. 429 "Skin
Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)
• Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission
Following a preliminary screening test, three groups, each of five
animals, were treated with 50 µl (25 µl per ear) of the undiluted test
material or the test material as a solution in dimethyl formamide at
concentrations of 25% or 50% v/v. A further group of five animals was
treated with dimethyl formamide alone.
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:
Stimulation index = 2.53 (25% conc.), 1.97 (50% conc.), 2.47 (100% conc.)
Result: negative for all concentrations tested
The test material was considered to be a non-sensitiser under the
conditions of the test.
No evidence of skin sensitisation potential was seen in a GLP compliant
Local Lymph Node Assay performed according to OECD Guideline 429
(Sanders, 2007) with triethyl phospate. This negative result is
consistent with briefly summarised information on skin sensitization in
Guinea pigs (Deichmann, 1969). The test material was considered to be a
non-sensitiser under the conditions of the test.
In the key study (LLNA) no evidence of skin sensitisation was seen. This
result is suppoerted by an insufficient reported skin sensitization
assay in guinea pigs. Therefore a classification for skin sensitization
is not warranted.
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