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EC number: 257-406-8
CAS number: 51772-35-1
A GLP compliant combined 28-day repeated
dose toxicity study with the reproduction/developmental toxicity
screening test was performed in male and female Wistar Han rats at dose
levels of 62.5, 250 and 1000 mg/kg bw/day. Animals of the control group
received the vehicle, propylene glycol, alone.Males
were exposed for 29 days, i.e. 2 weeks prior to mating, during mating,
and up to termination. Females were exposed for 40-54 days, i.e. during
2 weeks prior to mating, during mating, during postcoitum, and during at
least 4 days of lactation. The following observations and examinations
were evaluated: mortality / viability, clinical signs (daily),
functional observations and locomotor activity (Males: Week 4; females:
end of lactation), body weightand
food consumption (at least at weekly intervals), clinical pathology
(Males: Week 4; females: end of lactation), macroscopy at termination,
organ weights and histopathology on a selection of tissues, and
reproduction/developmental parameters, consisting of mating, fertility
and conception indices, precoital time, number of corpora lutea and
implantation sites, gestation index and duration, parturition, maternal
care, sex ratio and early postnatal pup development (mortality, clinical
signs, body weights and macroscopy). Accuracy, homogeneity and stability
of formulations were demonstrated by analyses.
At 1000 mg/kg bw/day, there was an
increased severity of multifocal hypertrophy in the adenohypophysis of
the pituitary gland in males. The severity (moderate) was higher than
background for a single male. No toxicologically relevant changes were
noted in any of the remaining parental parameters investigated in this
study (i.e. clinical appearance, functional observations, body weight,
food consumption, clinical laboratory investigations, macroscopic
examination and organ weights). No developmental toxicity was observed
up to the highest dose level tested (1000 mg/kg bw/day).
In conclusion, treatment with the test
article by oral gavage in male and female Wistar Han rats at dose levels
of 62.5, 250 and 1000 mg/kg body weight/day revealed histological
findings at 1000 mg/kg body weight/day characterized by an increased
severity of multifocal hypertrophy in the adenohypophysis of the
pituitary gland in males only. As this was higher thanbackground
in only a single male, when taken together in the absence of any other
toxicologically relevant effects, the NOAEL was considered to be 1000
mg/kg bw/day for parental animals. No reproduction
and developmental toxicity was observed for treatment up to 1000 mg/kg
body weight/day. Based on these results, a parental, reproduction and
developmental No Observed Adverse Effect Level (NOAEL) of at least 1000
mg/kg bw/day was derived.
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