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EC number: 201-622-7
CAS number: 85-68-7
A well-conducted study was performed in rats to assess the potential of
benzyl butyl phthalate to cause developmental toxicity.
Using a similar protocol to that outlined by OECD Test Guideline 414,
groups of 30 pregnant rats were given diets containing 0, 0.5, 1.25 or
2% benzyl butyl phthalate (providing 0, 420, 1100 or 1640 mg/kg bw/day
respectively) on days 6 -15 of pregnancy. Maternal weight gain, clinical
signs and food and water intakes were monitored, and the dams were
killed on day 20 of pregnancy. The uterus, liver and kidney were
weighed, and some livers from the high-dose and control groups were
examined microscopically. The uterine contents were examined for
implantations and resorptions. Viable foetuses were weighed and
evaluated for external, soft tissue and skeletal malformations.
At 1.25% in the diet, the mothers showed reduced weight gain during
treatment, increased relative liver weight and increased relative food
and water intakes. At this dose there was a slight (but not
statistically significant) increase in the numbers of litters with
external, visceral and skeletal malformations.
At 2% in the diet, the maternal effects described above were more
pronounced and accompanied by increased kidney weights; there were also
clinical signs of toxicity including hair loss, piloerection, coat
discolouration, lethargy, excessive urination, muscular weakness and
abnormal gait. Foetal malformations were statistically significantly
increased (53% malformed foetuses per litter compared to 2% in
controls), with the urogenital system, eye, heart and axial skeleton
most frequently affected. Increased resorptions and reduced foetal body
weights were also reported.
In conclusion, the NOAEL for both maternal and foetal effects was 0.5%
(420 mg/kg bw/day).
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