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EC number: 276-038-9
CAS number: 71808-53-2
Group mean achieved dosages of Quaternary ammonium compounds, C12-18-
alkylbis(hydroxyethyl)methyl, chlorides (CAS No 71808-53-2) in mg/kg
bw/day during the study are given in Table 1 and are calculated using
nominal concentrations for dietary formulations.
At 1500 ppm A.I., the mean achieved intake for males was 92.0 mg/kg
bw/day and for females it was 112.2 mg/kg bw/day. Overall, animals of
either sex achieved approximately 10.2 fold interval between the high
dietary level and the low dietary level.
At 400 ppm A.I., the mean achieved intake for males was 24.0 mg/kg
bw/day and for females it was 27.8 mg/kg bw/day. Overall, males achieved
approximately 2.7 fold interval between the intermediate dietary level
and the low dietary level whilst for females the interval was
approximately 2.5 fold.
At 150 ppm A.I., the mean achieved intake for males was 9.0 mg/kg bw/day
and for females it was 11.0 mg/kg bw/day.
The study was designed to investigate the systemic toxicity of the test
item and is compatible with the requirements of the OECD guidelines for
Testing of Chemicals No. 408 “Subchronic Oral Toxicity - Rodent: 90 Day
Study” (adopted 21 September 1998). This study was also designed to be
compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008
laying down test methods pursuant to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH).
The test item was administered by continuous dietary admixture to three
groups, each of ten male and ten female Wistar Han™:RccHan™:WIST strain
rats, for ninety consecutive days, at dietary concentrations of 150, 400
and 1500 ppm (Active Ingredient (A.I.)) (equivalent to a mean achieved
dosage of 9.0, 24.0 and 92.0 mg/kg bw/day and 11.0, 27.8 and 112.2 mg/kg
bw/day for males and females respectively). A control group of ten males
and ten females were treated with basal laboratory diet.
Clinical signs, functional observations, body weight change, dietary
intake and water consumption were monitored during the study. Hematology
and blood chemistry were evaluated for all animals at the end of the
study. Ophthalmoscopic examination was also performed on control group
and high dose animals before the start of treatment and during Week 12
of the study.
All animals were subjected to gross necropsy examination and a
comprehensive histopathological evaluation of tissues was performed.
There were no unscheduled deaths.
At 1500 ppm A.I., two males and all females showed clinical signs of fur
staining towards the end of the treatment period. Such observations
indicate lack of proper grooming and are considered to represent the
poor clinical condition of the animals.
There were no other signs of toxicological significance.
There were no treatment-related changes in behavioral parameters
Functional Performance Tests
There were no toxicologically significant changes in functional
Sensory Reactivity Assessments
There were no treatment-related changes in sensory reactivity.
Body weight gain was noticeably lower throughout the study for animals
of either sex treated with 1500 ppm A.I. when compared to controls.
Overall body weight gain was 45% lower for both males and females at
this level. These findings were considered to be of an adverse nature.
There were no adverse effects of treatment with the test item at dose
levels of 400 or 150 ppm A.I. in animals of either sex.
Males treated with 1500 ppm A.I., showed a reduced food intake
throughout the study. There were no effects detected in females treated
at 1500 ppm A.I. or animals of either sex treated with 400 or 150 ppm
Animals of either sex treated with 1500 ppm A.I. showed reduced food
conversion efficiency throughout the study when compared to controls.
The corresponding values for animals of either sex treated with 400 or
150 ppm A.I. were generally similar to controls.
There were no treatment-related effects detected in water consumption.
There were no treatment-related ocular effects detected.
Estrous Cycle Assessment
There was no effect of treatment with the test item on estrous cycling
activity assessed over the last three weeks of dosing in females.
Males and females treated with 1500 ppm A.I. showed a statistically
significant increase in total leukocyte count and neutrophils when
compared to controls. Group mean lymphocyte values in these animals were
also higher than controls but without attaining statistical
significance. The majority of individual values exceeded the background
control ranges, and these observations were deemed to be of
There were no other toxicologically significant effects on the
hematological parameters measured for animals of either sex treated with
400 or 150 ppm A.I.
Males treated with 1500 ppm A.I. showed statistically significant
increase in aspartate aminotransferase and alanine aminotransferase
activity. The majority of the individual values were above the
background control ranges, and these findings were considered to be
related to adaptive microscopic changes in the liver from these males.
Males treated with 1500 ppm A.I. showed a statistically significant
increase in urea. There was no effect on the associated creatinine
concentration in these males whilst the corresponding values in females
from this dose group were similar to controls. Although all individual
urea values in test item treated males were within the background
control ranges taken together with the degeneration changes in kidneys
this finding may possibly be toxicologically significant.
There were no other toxicologically significant effects on blood
chemistry parameters measured on animals of either sex treated with 400
or 150 ppm A.I.
All males and eight females treated with 1500 ppm A.I. had a raised non
glandular region of the stomach at necropsy, this correlated with
microscopic changes in the non-glandular region of the stomach at this
No other treatment related findings were observed at any dose level.
There were no toxicologically significant effects detected in the organ
Analyses of sperm concentration, motility, morphology and homogenisation
resistant spermatid counts did not identify any treatment-related
The following treatment related microscopic abnormalities were detected:
Adrenal Gland: Hypertrophy of the zona glomerulosa was present in
5/10 males and females treated with 1500 ppm A.I. This finding was
considered to be of adaptive in nature.
Stomach: Changes were present in the stomach of all males and
9/10 females treated with 1500 ppm A.I. The changes included ulceration,
erosion and various degrees of hyperplasia, all affecting the
non-glandular region. This finding was considered to be adverse but not
linked to man.
Caecum: Hyperplasia of the mucosa of the caecum was present in
all males and 7/10 females treated with 1500 ppm A.I., also inflammation
was present in all males and 6/10 females. These findings may be due to
direct irritation or upset in the flora or contents in the intestines.
Kidneys: Various changes were apparent in most males and all
females treated with 1500 ppm A.I. These included tubular dilation,
especially in the medullary tubules, increased basophilic tubules and
brown pigment deposition. This finding was considered to be degenerative.
Liver: Periportal basophilia (homogenous, darker staining cells)
was present in 5/10 males treated with 1500 ppm A.I. This finding was
considered to be of adaptive in nature.
Mesenteric Lymph node: Erythrocytosis was present in 6/10 males
treated with 1500 ppm A.I. compared to 1/10 controls. This finding was
considered to be an unknown etiology.
The continuous oral (dietary) administration of Quaternary ammonium
compounds, C12-18- alkylbis(hydroxyethyl)methyl, chlorides (CAS No
71808-53-2) to rats, at a dietary concentration of 1500 ppm A.I. for
ninety consecutive days, at 1500 ppm A.I. resulted in animals of either
sex showing an adverse reduction in body weight gains and reduced food
consumptions in the males. The histopathological findings observed at
this dose level in animals of both sexes included adverse changes in the
kidneys, stomach and caecum with some males also showing erythrocytosis
in mesenteric lymph node, a change that may be associated with changes
with caecal changes. In addition, changes to the adrenal glands and
liver were deemed likely to be adaptive in nature.
There were no toxicologically significant effects for animals of either
sex at dose levels of 400 or 150 ppm A.I. and therefore a No Observed
Adverse Effect Levels (NOAEL) for systemic toxicity for animals of
either sex was considered to be 400 ppm A.I., equivalent to a mean
achieved dosage of 24.0 mg/kg bw/day for males and 27.8 mg/kg bw/day for
females within the confines of this study.
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