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EC number: 640-387-9
CAS number: 61477-40-5
Test item concentration
Mean DPM peranimal (2 lymph nodes)a)
Vehicle Control Group (DMF)
The animals did not show any signs of systemic toxicity during the
course of the study and no cases of mortality were observed. On day 3
and 4, the animals treated with a test item concentration of 1% showed
an erythema of the ear skin (score 1). Animals treated with 0.25 or 0.5%
test item concentration did not show any signs of local skin irritation.
A statistically significant or biologically relevant increase in ear
weights was not observed in any treated group in comparison to the
vehicle control group. Furthermore, the cut-off value (1.1) of the ear
weight index for a positive response regarding ear skin irritation
reported for BALB/c mice (see Ref. 9) was not exceeded in any of the
A statistically significant or biologically relevant increase in lymph
node weights or –cell counts was also not observed in any of the test
item treated groups in comparison to the vehicle control group. For
BALB/c mice, a cut-off value for the lymph node cell count index of 1.55
was reported for a positive response (See Ref. 8). The indices
determined for the lymph node cell count did not exceed this threshold.
The test item 3-Amino-butan-1-ol was thus not a skin sensitizer under
the test conditions of this study.
There are no studies available for (R)-3 -Amino-butan-ol, only for the
racemat 3-Amino-butan-1 -ol.
In this study the test item 3-Amino-butan-1-ol was assessed for its skin
sensitizing potential using the Local Lymph Node Assay (LLNA, OECD 429 )
in mice. Test item solution at different concentrations was prepared in
the vehicle DMF. For this purpose a local lymph node assay was performed
using test item concentrations of 0.25, 0.5 and 1% (w/w). The highest
concentration tested was the highest concentration that could be
achieved whilst avoiding systemic toxicity and excessive local skin
irritation. In this study Stimulation Indices (S.I.) of 1.21, 1.28 and
1.69 were determined with the test item at concentrations of 0.25, 0.5
and 1% (w/w) in DMF, respectively. The test item 3-Amino-butan-1-ol was
thus not a skin sensitizer under the test conditions of this study.
No need for
classification according to Annex VI of Directive 67/548/EEC and
according to the EU Classification, Labelling and Packaging of
Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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