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EC number: 201-622-7
CAS number: 85-68-7
In a reliable study, hindlimb stiffness was seen in rats given benzyl butyl phthalate (BBP) in the diet at 3000 mg/kg bw/day for 44 days, but there was no evidence of neuropathological abnormalities on microscopic examination of tissues from the peripheral and central nervous system. The study was performed in compliance with GLP (Bischoff, 1983; Branch, 1982). A study in hens provided no evidence of neurotoxicity with BBP (Monsanto, 1992). Microscopic examination of central and peripheral nervous tissue from several mammalian species collected from a number of repeated-dose and chronic bioassays has also produced no evidence of neuropathology.
In a 6-week study, groups of 10 male and 10 female Sprague Dawley rats
were given benzyl butyl phthalate in the diet at levels providing about
500, 1500 or 3000 mg/kg bw/day. A control group of 6 males and 6 females
received diet only. At the end of treatment, half the animals in each
group were subjected to a gross pathology examination and half were sent
to another testing facility for neuropathological examination. Stiffness
of the hind limbs was seen at 3000 mg/kg bw/day (in 3 males from week 1
and 6 by week 6, and in 2 females during weeks 4 -6), an effect that was
apparently reversible once exposure had ceased. Body weight and food
consumption were lower in the top two dose groups in both sexes. There
were no effects on gross pathology, and no evidence of histopathological
abnormalities in tissues from the peripheral and central nervous system
(Bischoff, 1983; Branch, 1982).
The EU RAR reports a 42 -day study in which groups of 10 hens were
treated orally with BBP (5000 mg/kg bw/day) or tri-o-tolyl phosphate
(positive control) for three consecutive days and then again 21 days
later. The positive controls showed signs of neurotoxicity within 11 -18
days of dosing, whereas no such effects were seen in the BBP-treated
birds (Monsanto, 1992).
Microscopic examination of central and peripheral nervous tissue from
several mammalian species collected from a number of repeated-dose and
chronic bioassays has also produced no evidence of neuropathology.
The available data are sufficient to conclude that BBP does not need to
be labelled for neurotoxicity under the EU CLP regulations.
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