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EC number: 948-040-6
CAS number: -
Individual animal DPM
Mean group DPM
(acetone: olive oil 4:1 v/v)
10 % test item
25 % test item
50 % test item
Index (SI) of ≥ 3.0 indicates a positive result
OECD 429 (2018) - In a
dermal sensitization study with Reaction mass of
N,N,N’,N’-tetrabutylmethylenediamine and dibutylamine in acetone: olive
oil (4:1 v/v) young female adult mice (CBA/CaCrl) were tested using the
Local Lymph Node Assay (LLNA).
Following a preliminary
screening test in which no clinical signs of toxicity were noted at a
concentration of 50 %, this concentration was selected as the highest
dose investigated in the main test. Three groups, each of five animals,
were treated with 25 μL of the test item in solution in the vehicle at
concentrations of 50, 25 and 10 % v/v. A further group of five animals
was treated with the vehicle alone. A concurrent positive control test,
using a group of five animals, was also performed with the known
sensitiser, α-Hexylcinnamaldehyde at a concentration of 25 % v/v in the
There were no signs of
systemic toxicity or skin irritation through the test period. Ear
thickness were also within the normal range. There were no clinical
abnormalities or macroscopic abnormalities of the surrounding area were
noted for any of the animals and no mortality reported during the study.
The Stimulation Index, expressed as the mean radioactive incorporation
for each treatment group divided by the mean radioactive incorporation
of the vehicle control group, was determined for each treatment group.
The test item did elicit a
Stimulation Index ≥ 3 when tested at ≥ 25 % v/v with SI values of 2.60,
11.61 and 17.20 in the 10, 25 and 50 % w/v test groups, respectively.
The test item was therefore considered to be a sensitiser under the
conditions of the test. The EC3value, the concentration of
test item expected to cause a three-fold increase in3HTdR
incorporation (EC3value) was calculated to be 10.7 %.
In this study,
N,N,N’,N’-tetrabutylmethylenediamine and dibutyylamine was a dermal
on the condition of this study, the test item was classified as a
in accordance with Regulation (EC) No 1272/2008.
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