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EC number: 202-319-2
CAS number: 94-28-0
combined 28-day repeated dose toxicity study with the
reproduction/developmental toxicity screening
test of 2,2’-ethylenedioxydiethyl bis (2-ethylhexanoate) in rats by
At 15000 ppm, parental toxicity consisted of decreased
motor activity for females, decreased body weight gain for males and
females, haematological changes for females (increased prothrombin
time), changes in clinical biochemistry parameters (increased glucose
and decreased sodium levels for males, increased potassium levels for
both sexes), organ weight changes (increased liver and kidney weights
for both sexes, slightly decreased thymus weights for females) and
histopathological findings. Microscopic findings related to treatment
were recorded in the adrenal glands (multifocal vacuolation in zona
glomerulosa), kidneys (cortical hyaline droplets and corticomedullary
tubular basophilia along with a single instance of granular casts),
liver (diffuse midzonal/centrilobular hypertrophy), pituitary gland
(adenohypophyseal multifocal hypertrophy), spleen (increased hemosiderin
pigment along with a reduction in primarily erythroid hemopoietic foci),
thymus (lymphoid atrophy (involution)) and thyroid glands (diffuse
follicular hypertrophy/hyperplasia) for males and/or females.
At 5000 ppm, increased liver weights (females) and kidney
weights (males) were noted. In the absence of microscopic findings,
these changes were not considered toxicologically significant.
No treatment-related toxicologically significant changes
were noted in any of the remaining parental parameters investigated in
this study (i.e. clinical appearance, food consumption, and macroscopic
No reproductive/developmental toxicity was observedat any
At the control group, out of ten paired females only
seven were pregnant. The guideline mentions that eight pregnant females
per group normally is the minimum acceptable number of pregnant females
per group. However, seven for the control group was considered
sufficient for meaningful evaluation of the potential of the test
substance to affect reproduction and development as historical control
data was available.
In conclusion, treatment with 2,2’-ethylenedioxydiethyl
bis (2-ethylhexanoate) by dietary administration in male and female
Wistar Han rats at dose levels of 1500, 5000 and 15000 ppm revealed
parental toxicity at 15000 ppm. No reproduction and developmental
toxicity was observed for treatment up to 15000 ppm. Based on these
results, a parental NOAEL of 5000 ppm (corresponding to 314 -576 mg/kg
bw) was derived. The reproductive and developmental NOAEL was at least
15000 ppm (corresponding to 977 -1563 mg/kg bw).
When corrected for mean test article intake the NOAEL of 5000 ppm
corresponds to 314-576 mg/kg body weight/day and the NOAEL of 15000 ppm
corresponds to 977-1563 mg/kg body weight/day.
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