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EC number: 202-597-5
CAS number: 97-63-2
In a valid guideline study, n-BMA resulted in fetal toxicity, but no
teratogenicity, at concentrations that also produced maternal toxicity.
SIAR concluded for this study: “EMA was studied, using a method
equivalent to OECD Guideline 414, ingroups of 19-25 pregnant female rats
(whole-body inhalation exposure for 6 hr/day, during days 6 to 20 of
gestation), at exposure concentrations of 0, 600, 1200, 1800 or 2400 ppm
(0, 2844, 5688, 8532 or 11376 mg/m3). No maternal deaths were observed. Maternal
toxicity (decreased body weight gain) was shown at 1200 ppm (5688 mg/m3)
and above. Feed consumption was decreased at 600 ppm (2844 mg/m3) and
above. There was no significant effect of treatment on the mean number
of implantations and live fetuses, or on the fetal sex ratio. Fetal body
weight was significantly reduced at 1200 ppm (8532 mg/m3) (males only)
and higher concentrations (both sexes). Single cases of malformations
were seen in all groups (including controls) with no indication of
adverse effects due to EMA exposure. There were no significant
differences between the control and treated groups for
external(morphological), visceral (primarily distended ureter), or
skeletal variations (primarily incompletely ossified sternebrae and/or
vertebrae, and/or supernumerary ribs). EMA
produced no embryo/fetal lethality or fetal malformations at exposure
concentrations producing overt maternal toxicity. The NOAEC for
developmental toxicity was considered to be 600 ppm (2844 mg/m3) EMA
(Saillenfait et al., 1999).”
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