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EC number: 617-901-5
CAS number: 866607-35-4
In a Local Lymph Node Assay (LLNA) in mice (CBA/Ca) according to OECD
Guideline 429 the test item T003066 was found to be a skin sensitiser
and should be classified as skin sentitiser category 1B based on the
calculated EC3 value ( > 5%). A precise calculation of the EC3 value was
not possible since the S.I. was above the threshold of 3 even at the
lowest tested concentration), according to CLP Regulation. (Wolf, 2008).
- Viability/mortality: no deaths
occured during the study period.
- Clinical signs: no symptoms of
local toxicity at the ears of the animals and no systemic findings were
observed during the study period.
Body weights: the body weight of the animals, recorded prior to the
first application and prior to the treatment with ³HTdR, was within the
range commonly recorded for animals of this strain and age.
In a key LLNA study by
Wolf (2008), three experimental groups of four female CBA/J mice were
treated with test item concentrations of 1, 10 or 25% v/v for three
consecutive days, by topical application on the dorsal
surface of each ear lobe (left and right).
Four vehicle control animals were similarly treated, but with vehicle
alone (Methyl ethyl ketone).
Five days after the first
topical application, all animals were injected with 3H-methyl
thymidine and after five hours the draining (auricular) lymph nodes were
excised and pooled for each animal. After precipitating the DNA of the
lymph node cells, radioactivity measurements were performed. The
activity was expressed as the number of Disintegrations Per Minute (DPM)
and a stimulation index (SI) was subsequently calculated for each group.
Mean DPM/animal values
for the experimental groups treated with test item concentrations 1, 10
and 25% were 4335,
6932 and 6310
DPM, respectively. Since
the lymph nodes of the animals of a dose group were pooled, DPM/nodewas
determined by dividing the measured value by the number of lymph nodes
pooled. The SI values
calculated for the test item concentrations 1, 10, and 25 % were 2.01,
3.23 and 2.94, respectively.
A precise calculation of the EC3 value was not possible since the S.I.
was above the threshold of 3 even at the lowest tested concentration),
according to CLP Regulation.
Based on the results the test item T003066 was found to be a skin
sensitiser and should be classified as skin sentitiser category 1B based
on the calculated EC3 value (8.3 %), according to CLP Regulation.
An in vitro or in chemico skin sensitisation study was waived based on
the justification that adequate data from an in vivo skin sensitisation
study (initiated before October 11th 2016) were available.
Based on the results of
the LLNA study in female mice (CBA/Ca), the test item should
be classified as skin sentitizer category 1B according to the criteria
of the CLP regulation (EC) No 1272/2008.
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