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EC number: 200-300-3
CAS number: 56-93-9
A preliminary screening study was conducted with concentrations of 10%,
25% and 50% w/w in 1% Pluronic L92 surfactant in distilled water and the
vehicle alone. The top dose of 50% was selected based on maximum
solubility, compatibility, and viscosity of the test substance with the
vehicle while maintaining a pipettable solution that could be applied to
the mouse ear (documented in the raw data). On Days 1, 2, 3 and/or 6,
each dose site was evaluated for local irritation. One mouse from Group
4P (50% concentration) was found dead on Day 6. There were no clinical
signs of toxicity prior to death. Gross necropsy revealed discoloration
of the lungs and intestines. All other mice appeared active and healthy.
There was no dermal irritation observed in the vehicle control group or
10% test concentration group. Very slight erythema was seen at the 25%
and 50% concentrations.
Based on the results of the screening assay, 10%, 25% and 50% w/w
concentrations in 1% Pluronic L92 surfactant in distilled water and the
vehicle alone were evaluated in the main study. Four out of five mice
from the 50% concentration were found dead by Day 6. All surviving mice
appeared active and healthy, and there were no consistent
treatment-related effects on body weight for the survivors over the
course of the study. There was no dermal irritation noted for the
treatment group at the 10% concentration and very slight erythema
observed at various time points at the 25% and 50% concentrations. Due
to the mortality of the four animals at the 50% concentration, an
additional dose level of 35% was evaluated, along with an additional
vehicle control group. However, due to the death of two of the five mice
by Day 1 at the 35% concentration, all animals from the test and vehicle
control groups were euthanized for humane reasons on Day 2. There was no
dermal irritation and no clinical signs of toxicity observed in the mice
from either of these groups prior to death.
Gross necropsy of two of the decedents from the 50% treatment group
revealed discoloration of the intestines. No gross abnormalities were
noted in the two other decedents at 50%, the decedents at 35% or for the
euthanized animals from the additional vehicle control and 35% groups
(Groups 6 and 7).
No dermal irritation was observed at any site in the original vehicle
control group (Group 1). Very slight to well-defined erythema and slight
edema was noted in the positive control group (Group 2).
Treatment of mice with 10% and 25% of Benzyltrimethylammonium Chloride
(BTMAC) resulted in stimulation index values of 1.06 and 1.32,
respectively, relative to vehicle control mice. As a stimulation index
(SI) of greater than 3.0 was not observed, Benzyltrimethylammonium
Chloride (BTMAC) was considered negative for dermal sensitization
potential in the LLNA at concentrations of less than or equal to 25%.
Proper conduct of the LLNA was confirmed via a positive response with
25% HCA, a moderate contact sensitizer, which elicited a proliferative
response with a SI value of 4.16 relative to vehicle controls.
Table 1 DPM values for each treatment group
1 Mean + Standard Deviation
This study was conducted at Eurofins Product Safety Labs (EPSL) under
contract of REACHCentrum, “RC”, representing the member companies of the
BTMAC SIEF Leadership Team, “SLT”: Polystar Europe SLU, SACHEM Europe
B.V., TANATEX Chemicals B.V. and Dow Duetschland Anlagengesellschaft
mbH. Dow is a paying and participating member of REACHCentrum and as
such is a co-owner of this study.
A dermal sensitization test was conducted with female mice to determine
the potential for Benzyltrimethylammonium Chloride (BTMAC) to produce
sensitization after repeated topical applications. Three concentrations
(10%, 25% and 50%) of the test substance in 1% Pluronic L92 surfactant
in distilled water or the vehicle alone were initially topically applied
to twenty healthy female test mice (5 mice/group) for three consecutive
days. Due to mortality observed at the 50% concentration, an additional
dose level of 35% of the test substance and an additional vehicle
control group were added to the study to aid in the interpretation of
the sensitization potential of the test substance. There were five
female mice in each of these groups. The 35% concentration was also
terminated due to mortality; therefore, 25% was the maximum tolerated
dose. Three days after the last application, the surviving mice were
given a 20 μCi IV injection of 3H-methyl thymidine. Five hours later,
the draining (auricular) lymph nodes were harvested and prepared for
analysis in a scintillation counter. The results are presented in
disintegrations per minute per mouse (dpm/mouse). Each animal’s ears
were also evaluated for erythema and edema prior to each application and
again on Day 6, prior to the IV injection. A positive control group
(five female mice) was maintained under the same environmental
conditions and treated with a 25% w/w mixture of
alpha-Hexylcinnamaldehyde Technical (HCA) in 1% Pluronic L92 surfactant
in distilled water in the same manner as the test animals. A table
summarizing the results of the LLNA is found below:
As a stimulation index (SI) of greater than 3.0 was not observed,
Benzyltrimethylammonium Chloride (BTMAC) was considered negative for
dermal sensitization potential in the LLNA at concentrations of less
than or equal to 25%. Proper conduct of the LLNA was confirmed via a
positive response with 25% HCA, a moderate contact sensitizer.
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