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EC number: 203-794-9
CAS number: 110-71-4
Results of Study b:
Eight males and five females in the 4500 ppm group and all males and
females in the 6000 ppm grooup did or were killed prior to scheduled
termination.The final mean body weights for males and females receiving
1500 to 4500 ppm were notably lower than values for the control group.
Body weight analyses were not performed for males or females in the 6000
ppm group due to 100% mortality. Decreaes in mean water consumtion were
noted for males and females in the 3000 and 6000 ppm group as well as
for females in the 1500 ppm group. For male and female rats, clinical
signs of toxicity considered to be chemical related included tremors,
emaciation, abnormal posture, pallor, tachypnea, hypoactivity and
At week 1 in the hematologic evaluations, mild anemia, moderate
leukopenia, and moderate thrombocytopenia were present in male rats in
the higher dose groups. These animals had decreases in hematocrit (HCT)
and hemoglobin (HGB) concentrations and in erythrocyte (RBC), platelet,
and total leukocyte counts. The anemia was normocytic (no change in mean
cell volume), normochromic ( no chenge in mean cell hemoglobin
concentration), and poorly regenerative (indicated by a decrease in
reticulocyte count). Leukopenia was produced by decreases in neutrophils
and lymphocytes. There were moderate decreases in bone marrow
cellularity counts in the rats in the higher dose groups. At weeks 3 and
13, the anemia was moderate, progressive, normocytic, and normochromic,
with inadequate regeneration (lymphopenia and neutropenia) and
thrombocytopenia were present at each time point, and bone marrow
cellularity counts were decreased in male rats in the higher dose groups
at week 13.
Changes in clinical chemistry variables at the various time points for
male rats included decreases in creatinine, total protein, albumin, and
alkaline phosphatase (AP) (all consistent with decreased food intake)
and mild increases in concentrations of bile acids at weeks 1 and 13.
At week1, female rats had a mild normochromic, poorly regenerative
anemia. At weeks 3 and 13, the anemia remained mild but, unlike that in
male rats, was slightly microcytic (weeks 1 and 13). Reticulocyte counts
were unchanged in the presence of anemia at weeks 1 and 13. Moderate
thrombocytopenia and leukopenia (lymphopenia and neutropenia) occured at
all time points in numerous dose groups. Bone marro cellularity was
decreased by treatment at weeks 1 and 3 but was unchanged at week 13.
Clinical chemistry effects in female rats included decreases in AP
activity and total protein and albumin concentrations in numerous dose
groups at all time points. These findings are consistent with the
decreased feed consumption of these animals. Additionally, there were
mild increases in concnetraions of bile acids in multiple dose groups at
weeks 1 and 3.
For males and females, treatment-related parameters consisted of
decreases in urine volume and increases in specific gravitiy. With the
exception of changes in thymus and testis weights, changes in absolute
and relative organ weights could be attributed to low final mean body
weights. Dose-related decreases were noted for the absolute and relative
testis weights of male rats and the absolute thymus weightss of male and
Almost all observed gross lesions were considered to be secondary to the
marked reduction in bosy weight gain and the overall smaller size of
rats administered the higher exposure concentrations. The only gross
lesion attributed directly to the toxicity of 2 -Methoxyethanol was a
reduction in testis size in males at concentraions of 1500 ppm and
Histopathological changes in the testis consitisted of a minimal to
marked degeneration of germinal epithelium in the seminiferous tubules;
in more severely affected rats, the atrophic seminiferous tubules
contained only Sertoli cels and a few spermatogonia. The presence of
cell debris and a decrease in sperm within the lumen of the epididymis
were associated with these changes. Degeneration was present at all dose
levels but was only minimal in 7 of 10 rats in the 750 ppm group.
Additionally, a chemical-related fibrosis of the splenic capsule was
present in male and female rats and was most prominent in animals in the
1500 to 4500 ppm groups. This fibrosis was characterised by focal areas
in which there was thickening of the splenic capsule by fibrous
connective tissue and a minimal mixed inflammatory cell infiltrate;
inflammation and fibrosis of the serosal surfaces of other abdominal
organs did not occur.
Other micoscopical changes were associated with the marked reduction in
body weight gain or stress-related physiological changes typically seen
in animals that die during study or are killed moribund. Specifically,
these changes included atrophy of the clitoral/preputial glands, uterus,
ovary, salivary glands, and prostate. Atrophic changes included not only
an overall reduction in the size of the organs but a depletion of
secretory product in the lumen of glands, decreased height of the
secretory epithelium, and an increased number of degenerative and
apototic cells. Lymphoid depletion (atrophy) in lymph nodes, thymus and
spleen, bone marrow depletion, absence of metaphyseal bone growth, focal
erosion/ulcerations of the glandular stomach, and focal proliferation of
bacterial or fungal organisms were also seen in animals that died or
were killed moribund during the study; these lesions were considered to
be secondary to the marked generalized toxicity and reduction in body
weight gain seen in the 4500 and 6000 ppm groups.
Sperm morphology evaluations were performed on male rats treated with 0,
750, 1500 or 3000 ppm, and vaginal cytology evaluations were performed
on female rats treated with 0, 1500, 3000 or 4500 ppm. Tesicular and
epididymal weight were significantly lower than control values for males
receiving 1500 or 3000 ppm. Also, spermatozoal measurements were
significantly decreased for males in the two highest dose groups (1500
or 3000 ppm). There were no significant differences from control in
estrous cycle length for females treated with 2 -Methoxyethanol.
However, there was evidence to suggest that animals in the 1500 and 3000
ppm groups differed from the control animals in the relative frequency
of time spent in estrous stages. The lack of significance at the 4500
ppm dose level may have been due to increased variability and/or the
small sample size.
There is a strong evidence in literature that
Ethyleneglycoldimethylether is metabolised to 2-Methoxyethanol.
Therefore, a read across to the 2 and 13-week drinking water study study
with 2 -Methoxyethanol in mice was conducted.
The animals were treated with 0, 200, 400, 600, 1000 or 1200 mg/kg bw/d
2 -Methoxyethanol for 2 weeks or with 0, 750, 1500, 3000, 4500 or 6000
ppm 2 -Methoxyethanol for 13 weeks via drinking water.
2 weeks study:
No rats died or were killed before the end of the study. The final mean
body weights and mean body weights gains of males and females receiving
target doses of 600, 1000 or 1200 mg/kg bw/d were notably lower than
those of the control group. Dose-related decreases in mean water
consumption were noted for male and female rats. Dehydration, abnormal
posture, and thin appearance were noted for males treated with the two
highest concentrations (1000 and 1200 mg/kg bw/d) and all females in the
three highest dose groups (600, 1000 and 1200 mg/kg bw/d) were
dehydrated. Abnormal posture and thin appearance were observed in all
females in the two highest dose groups (1000 and 1200 mg/kg bw/d), and
all females receving the highest dose (1200 mg/kg bw/d) were emaciated
by the end of the study. Most changes in absolute and relative organ
weights were related to low body weights, excluding changes in thymus
and testis weights. Absolute and relative thymus weights decreased in a
dose-related fashion for males and females as did absolute and relative
testis weights for males. Chemical-related gross lesions were present
only in rats in the 1000 and 1200 mg/kg bw/d dose groups. Gross lesions
were observed in the forestomach and mesentric lymph nodes of male and
female rats receiving 1200 mg/kg bw/d and in females receving 1000 mg/kg
bw/d. Microscopic changes in the forestomach that corresponded to the
gross lesions included hemorrhage and edema of the mucosa and focal
necrosis and ulceration of the squamous epithelium. Mild hyperplasia of
the fore stomach squamous mucosa was also present and was generally
associated with the focal areas of necrosis or ulceration. Sinusoidal
congestion, hemorrhage, and erythrophagocytosis were present in the
mesentric lymph nodes, which appeared enlarged or reddened at necropsy.
In addition the chemical-related gross lesions, the testis and
epididymis from all doses and control rats were examined
microscopically. Degeneration was clearly present in the testis of male
rats in all but the lowest dose group (200 mg/kg bw/d). This
degeneration consisted of moderate to marked loss of germinal epithelium
and the presence of multinucleated spermatid giant cells and cell debris
in the lumen of seminiferous tubules. In male rats in the three highest
dose groups (600, 1000 and 1200 mg/kg bw/d), the lumen of the epididymis
contained necrotic cells and cell debris and only a few spermatozoa.
Degeneration was of mild severity at the targeted 400 mg/kg bw/d dose
level and in one of five rats administered the lowest dose (200 mg/kg
bw/d), there was minimal degeneration of the testes.
13 weeks study:
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