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EC number: 412-570-1
CAS number: 119462-56-5
A 28 day oral gavage study was performed with the test item in maize oil
on 5 male and 5 female CD rats per dose at dosages of 0, 10, 50 and 200
mg/kg bw/day according to OECD 407 in 1993. Satellite groups of 5
rats/sex/dose were simultaneously treated with 0 (vehicle alone) and 200
mg/kg bw/day to assess the reversibility of effects.
The dose of 200 mg/kg bw/day group resulted in death of four males and
one female. Clinical signs and histopathology (all of these animals had
hyperkeratosis and acanthosis of the keratinised region of the stomach
and one had accompanying ulceration) indicated that these deaths were,
at least in part, caused by an irritant effect of the test material on
the stomach wall. Most survivors also showed hyperkeratosis and
acanthosis and a higher incidence of acute inflammation of the glandular
and keratinised stomach regions compared with contol animals. After two
weeks recovery, the proportion of animals affected was much lower. A
slightly reduced body weight gain was seen in the high dose group and
clinical signs as salivation after dosing, ungroomed appearance and
At 50 mg/kg bw/day the clinical signs were similar but minor and nearly
dissapeared at 10 mg/kg bw.
Hyperkeratosis and acanthosis of the stomach were associated with gavage
administration of the test compound. The presence of these findings in
the high dosage group is likely to be the result of an irritant effect
of the test material rather than a toxic effect. The NOAEL in this study
is 50 mg/kg bw/day based on irritating effects in the stomach and its
consequences at 200 mg/kg bw/day. The NOEL was considered to be very
close to this dosage.
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