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EC number: 259-134-5
CAS number: 54381-16-7
effect on body weight or body weight gain was observed. The details on
body weight gain are provided in the study report (Table 1: weight gain
1: Local lymph node assay with N,N-Bis(2Hydroxyethyl)-P-Phenylenediamine
Sulphate (Study # 70775)
1% P- Phenylenediamine in DMSO
Calculated EC3 value (derived by linear interpolation) was at a
concentration of 1.04% of test substance.
Based on the above, it was stated that the test substance caused
reactions identified as sensitization up from a concentration of 1.04%
of test substance, where the stimulation index was equal to 3.0.
sensitisation test of N,N-Bis(2Hydroxyethyl)-P-Phenylenediamine Sulphate
(Blauentwickler) was performed following the methods comparable to OECD
429 guideline (Skin Sensitisation: Local Lymph Node Assay).
test material was assayed at concentrations of 0, 0.5, 2.5 and 5.0%. The
vehicle group received dimethylsulfoxide (DMSO). P- Phenylenediamine at
1% concentration in DMSO served as the positive control.
µL of test material or vehicle was applied to the dorsal surface of each
ear of each mouse consecutively for 3 d. Five days after the first
topical application treatment all mice were injected intravenously with
[3H]-methyl thymidine. Approx. 5 h after [3H]-methyl thymidine injection
all mice were sacrificed and the draining auricular lymph nodes were
excised, in order to prepare single cell suspension of the lymph node
thymidine incorporation was measured in a β- scintillation counter and
expressed as the number of disintegrations per minute (DPM). The
proliferative response of lymph node cells was calculated as the ratio
of 3H·methyl thymidine· incorporation into lymph node cells of test
group animals relative to that recorded for control group animals. A
stimulation index (SI), ratio of test substance / vehicle control, was
calculated for each concentration.
stimulation index for the positive control (1% P·Phenylenediamine) was
mean stimulation index for the test substance was 1.0, 0.7, 9.1 (>3) and
9.7 (>3) at 0 (vehicle control), 0.5, 2.5 and 5.0% concentration of test
substance is regarded as a 'sensitizer' in the LLNA if at least one
concentration of the test substance results in a 3-fold or greater
increase in 3H-methyl thymidine incorporation into lymph node cells
relative to the control group(stimulation
bis(2-hydroxyethyl)-p-phenylenediamine sulfate (Blauentwickler) caused
reactions identified as sensitization i.e. demonstrating a stimulation
in a Local lymph Node Assay. Calculated EC3 value (derived by linear
interpolation) was at a concentration of 1.04% of test substance.
under the conditions of this test Blauentwickler was categorised as a
strong sensitiser, Category 1A according to
LLNA study is classified as acceptable, and satisfies the guideline
requirements of OECD 429 (Skin Sensitisation: Local Lymph Node Assay).
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