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EC number: 204-667-0
CAS number: 123-96-6
Octan-2-ol was tested in a Local Lymph Node Assay (OECD 429) and
showed no sensitizing potential.
Concentration (% v/v) in acetone/olive oil 4:1
Disintegrations per Minute (dpm)
Disintegrations per Minute/Node (dpm/Node)
There were no deaths. No signs of systemic toxicity were noted in the
test or control animals during the test.
Bodyweight changes of the test animals between Day 1 and Day 6 were
comparable to those observed in the corresponding control group animals
over the same period.
test material was considered to be a non-sensitiser under the conditions
of a Local Lymph Node Assay conducted in accordance with OECD guideline
The objective of this study was to
evaluate the potential of the test item, to induce contact
hypersensitivity, using the murine Local Lymph Node Assay (LLNA).
To assess the irritant potential of
the test item (through ear thickness measurement), a preliminary test
was first performed in order to define the test item concentrations to
be used in the main test and suggested that the test material would not
produce systemic toxicity or excessive local irritation at the highest
suitable concentration (100%).
Groups of four mice were treated with
the undiluted test material or the test material at a concentration of
50% or 25% v/v in acetone/olive oil 4:1. The mice were treated by daily
application of 25 µl of the appropriate concentration of the test
material to the dorsal surface of each ear for three consecutive days
(Days 1, 2, 3). The test material/test material formulations were
administered using an automatic micropipette and spread over the dorsal
surface of the ear using the tip of the pipette. A further group of four
mice received the vehicle alone in the same manner.
Five days following the first topical
application of the test material or vehicle (Day 6) all mice were
injected via the tail vein with 250 µl of phosphate buffered saline
(PBS) containing3H-methyl thymidine (3HTdR: 80 µCi/ml, specific activity
2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 µCi to each mouse.
All animals were observed twice daily
on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of
toxicity or signs of ill health during the test were recorded. The
bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day
6 (prior to termination).
Approximately five hours following the
administration of 3HTdR all mice were killed by carbon dioxide
asphyxiation. The draining auricular lymph nodes from the four mice were
excised and pooled for each experimental group. For each group 1 ml of
PBS was added to the pooled lymph nodes.
After approximately eighteen hours
incubation at approximately 4°C, the precipitates were recovered by
centrifugation at 2100 rpm (approximately 450 g) for ten minutes,
resuspended in 1 ml of TCA and transferred to 10 ml of scintillation
fluid (Optiphase 'Trisafe').3HTdR incorporation was measured by
beta-scintillation counting. The "Poly QTM" vials containing the samples
and scintillation fluid were placed in the sample changer of the
scintillator and left for approximately twenty minutes. The purpose of
this period of time in darkness was to reduce the risk of luminescence,
which has been shown to affect the reliability of the results. After
approximately twenty minutes, the vials were shaken vigorously. The
number of radioactive disintegrations per minute was then measured using
the Beckman LS6500 scintillation system (Beckman Instruments Inc,
Fullerton, CA, USA).
There were no deaths. No signs of
systemic toxicity were noted in the test or control animals during the
test. Bodyweight changes of the test animals between Day 1 and Day 6
were comparable to those observed in the corresponding control group
animals over the same period.
The SI of the positive
control (alpha-Hexylcinnamaldehyde) was > 3; this experiment was
therefore considered valid.
No significant lymphoproliferation was
noted with the test item at any tested concentrations as all SI values
were below the cut-off value of 3.
the experimental conditions of this study, the test item gave a negative
result in the murine Local Lymph Node Assay, indicative of the absence
of skin sensitization properties. Therefore, the test item should not be
classified as a skin sensitizer according to the criteria of CLP
to the available data and CLP criteria, no classification is warranted
for the skin or respiratory sensitisation.
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