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EC number: 202-597-5
CAS number: 97-63-2
The following are the results from the original author:
Histological examination: Spongiform alterations in fiber tracts of the
forebrain, brainstem, and spinal cord. Clusters of axonal swellings were
scattered throughout the dorsal, ventral, and lateral columns of the
spinal cord, and typically involved internodal segments of two or three
neighboring axons. Shrunken axons with separated myelin lamellae and
large axons with thinner than normal myelin sheaths were apparent in the
sciatic nerve. The patterns of alterations in the white matter of the
spinal cord and the sciatic nerve are consistent with myelinopathy, but
additional experiments are necessary to confirm whether oligodendroglia
and Schwann cells are the primary sites of injury. In addition to the
alterations associated with myelin, there was a decrease in the density
of neurons in the ventral horn of the spinal cord.
Review of Garman:
The reviewing pathologist concluded that the empty spaces within the
spinal cord sections that were originally reported to represent axonal
enlargement actually represent foci of myelin artifact. In addition,
these foci of myelin artifact were thought to be qualitatively and
quantitatively similar between the control and EMA-treated groups. No
treatment-related microscopic findings were found within the sections of
sciatic nerve. Some evidence of myelin sheath separation was thought to
represent handling artifact and/or normal Schmidt-Lanterman incisures.
There was no evidence of any neuropathologic process within the sections
of brain examined (although only a representative number of the brain
sections were examined microscopically).
The authors concluded that daily administration of the test substance
can result in neurotoxicity in male rats. The results of the
histological evaluations where morphological (histological) alterrations
had been found in sections of brain, spinal cord and sciatic nerve at
all dose levels in the drinking water study (0.1-0.5% in dw.) were
subsequently deemed incorrect after further independent scientific
review (Garman, 2002).
SIAR reported potential neurotoxicity with EMA citing this study but
noted that a peer-review of the nervous system tissues collected in this
study concluded that the reported effects were most consistent with foci
of myelin artifacts.
In a reliable publsihed study, daily administration of the test
substance can result in neurotoxicity in male rats. The results of the
histological evaluations were subsequently deemed incorrect after
further scientific review (Garman 2002).
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