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EC number: 206-788-4
CAS number: 375-50-8
The substance caused skin sensitisation
reactions in a reliable study conducted according to Test Guideline OECD429
(Local Lymph Node Assay).
sensitisation potential of 1,4-Diiodoperfluorobutane following dermal
exposure in CBA/CaOlaHsd mice was assessed in the Local Lymph Node
Assay. The study was performed according to OECD Guideline No.: 429, and
in compliance with Good Laboratory Practices.
the results of the Preliminary Compatibility Test, the best vehicle for
the test item was Acetone:Olive Oil 4:1 (v:v) mixture (AOO) and the 100
% (w/v) formulation was chosen as the highest concentration suitable for
the Preliminary Irritation/Toxicity Test using two doses and 2
animals/dose, 100 % (w/v) in AOO was selected as top dose for the main
In the main
assay, twenty female mice were allocated to five groups (4 mice/group):
groups received 1,4-Diiodoperfluorobutane (formulated in AOO) at 100,
50, and 25 % (w/v) concentrations respectively,
negative control group received the vehicle (AOO) only,
positive control group received 25 % (w/v)α-Hexylcinnamaldehyde
(HCA) (dissolved in AOO).
item solutions were applied on the dorsal surface of ears of
experimental animals (25 μL/ear) for three consecutive days (Days 1, 2
and 3). There was no treatment on Days 4, 5 and 6. The cell
proliferation in the local lymph nodes was assessed by measuring
disintegrations per minutes after incorporation of tritiated methyl
thymidine (3HTdR) and the values obtained were used to calculate
stimulation indices (SI) in comparison with the control group.
mortality or signs of systemic toxicity were observed during the study.
No marked bodyweight
losses was observed on the mean body weight changes inany
body weight loss was ≥5% for 1/4 animals in the50
% (w/v) and the Positive Control group.
stimulation index (SI) values were 5.5, 2.3 and 1.1 at concentrations of
100, 50 and 25 % (w/v), respectively.
of the positive control substance HCA was used to demonstrate the
appropriate performance of the assay. A lymphoproliferative response in
line with historical positive control data was noted for the positive
control chemical, this result confirmed the validity of the assay.
conclusion, under the conditions of the present assay,
1,4-Diiodoperfluorobutane, tested in a suitable vehicle, was shown to
have a sensitisation potential in the Local Lymph Node Assay. The
extrapolated EC3 value of 1,4-Diiodoperfluorobutane is 60.9 % (w/v).
substance is classified as skin sensitizer Category 1 (sub-category 1B)
according to Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 6) 2015.
Results of a sensitisation assay using Test
Guideline OECD 429 showed a skin sensitising potential triggering
classification in sub-category 1B, according to criteria in EC CLP
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