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EC number: 939-478-9
CAS number: -
At 10% and 30% test item concentration, no signs of irritation and
systemic toxicity were noted.
White test substance remnants were present on the dorsal surface of the
ears of both animals at 10% (Days 2 and 3) and of both animals at 30%
(entire observation period)
results - main study:
Desintegrations per minute (DPM): Mean DPM/animal values for the
experimental groups treated with test item concentrations 0, 5, 10, and
30% were 525, 816, 1156 and 738 DPM, respectively.
Skin reactions: No irritation of the ears was observed in any of the
animals examined. White test substance remnants were present on the
dorsal surface of the ears of all animals treated at 5% (Days 1-3), 10%
(Days 1-4) and 30% (Days 1-5 and/or 6)
Bodyweight: Body weights and body weight gain of experimental animals
remained in the same range as controls
Systemic toxicity: No mortality occurred and no clinical signs of
systemic toxicity were observed
Macroscopy of the auricular lymph nodes: All auricular lymph nodes of
the animals of the experimental and control groups were considered
normal in size.
An LLNA was performed with URALAC P 1920C according to OECD guideline
429 and under GLP principles. Three experimental groups of five female
CBA/J mice were treated with test substance concentrations of 5, 10 or
30% w/w. No irritation of the ears was observed in any of the animals
examined. No mortality occurred and no clinical signs of systemic
toxicity were observed in the animals of the main study. Body weights
and body weight gain of experimental animals remained in the same range
as controls over the study period.
All auricular lymph nodes of the animals of the experimental and control
groups were considered normal in size. No macroscopic abnormalities of
the surrounding area were noted for any of the animals. Mean DPM/animal
values for the experimental groups treated with test substance
concentrations 5, 10 and 30% were 816, 1156 and 738 DPM, respectively.
The mean DPM/animal value for the vehicle control group was 525 DPM. The
SI values calculated for the substance concentrations 5, 10 and 30% were
1.6, 2.2 and 1.4, respectively.
Since there was no indication that the test substance elicits a SI ≥ 3
when tested up to 30%, URALAC P 1920C was not considered to be a skin
sensitizer. It was established that the EC3 value (the estimated test
substance concentration that will give a SI =3) (if any) exceeds 30%.
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