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EC number: 947-528-6
CAS number: -
One Guideline study on the endpoint "in vitro testing on skin
a second Guideline study is in progress.
This in vitro study evaluates the sensitizing potential of the test item
Bis(neodecanoyloxy)dioctylstannane by using the LuSens cell line. This
test is part of a tiered strategy for the evaluation of skin
sensitisation potential. Thus, data generated with the present Test
Guideline should be used to support the discrimination between skin
sensitizers and non-sensitizers in the context of an integrated approach
to testing and as-sessment.
The LuSens test is an ARE Reporter Gene Assay that was developed by the
BASF SE (Ludwigshafen, Germany) and is based on the OECD 442D Guideline
(KeratinoSens As-say). The assay differs in some points from the OECD
guideline however the proficiency of the LuSens test was demonstrated
(see chapter 6.5, page 13).
The assay included a cytotoxicity range finder test (CRFT) and two
independent experiments (experiment I and II) with a treatment period of
48 h. The CRFT was performed to detect a potential cytotoxic effect of
the test item. Based on the results of this test the con-centrations for
the two experiments were determined.
In the experiments, the highest nominal applied concentration (7.81 μM)
was chosen based on the results obtained in the CRFT. A geometric series
(factor 1.2) of eleven dilu-tions thereof was prepared. Precipitation of
the test item was not visible in any of the ex-periments.
DMSO (final concentration: 1 %) was used as solvent control and medium
no. 3 as growth control. Lactic acid (5000 μM) was used as negative
control and EGDMA (120 μM) as pos-itive control.
The evaluated experimental points and the results are summarised in
chapter 8 page 20ff.
No substantial dose dependent increase in luciferase induction ≥ 1.5
fold was observed in a minimum of 2 consecutive non-cytotoxic
concentrations in both experiments up to the maximal concentration of
the test item. Therefore, according to the protocol of the BASF SE the
LuSens test is negativ.
According to the OECD 442D the result is inconclusive.
Preliminary Screening Test Results
No signs of systemic toxicity, visual local skin irritation or excessive
irritation indicated by an equal to or greater than 25 % increase in
mean ear thickness were noted. Based on this information the dose levels
selected for the main test were 5, 10 and 25 % w/w test material in
Main Test Results
There were no deaths. No signs of systemic toxicity were noted in the
test or control animals during the study. Furthermore, 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
Positive Control Test Results
The stimulation index expressed as the mean radioactive incorporation
for the treatment group divided by the mean radioactive incorporation of
the vehicle control group was 3.49. Therefore, phenylacetaldehyde (90 %)
was considered to be a sensitiser under the conditions of the study.
Table 2: Disintegrations per Minute, Disintegrations per Minute/Node
and Stimulation Index
Concentration (% w/w) in vehicle
stimulation index #
dpm = Disintegrations per minute
* Disintegrations per minute/node obtained by dividing the
disintegrations per minute value by 8 (total number of lymph nodes)
# Stimulation index of 3.0 or greater indicates a positive result
na = not applicable
The skin sensitisation potential of the test material was determined in
accordance with the standardised guidelines OECD 429 and EU Method B.42
using the mouse Local Lymph Node Assay. The test material was applied as
a 5 %, 10 % or 25 % w/w preparation in propylene glycol. The positive
control was shown to have the capacity to cause skin sensitisation
confirming the validity of the protocol used for this study. Under the
conditions of the test the isotope concentration induced by the test
material was less than three-fold at all test concentrations. Therefore
the test material is considered to be unlikely to be a skin sensitiser
when administered as a preparation at ≤
25 % w/w.
An Endpoint conclusion can be made based on the results of two out of
three or three studies targeting the three identified steps in the
adverse outcome pathway which is the basic principle for the OECD
Guidelines 442C, 442D and 442E
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