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EC number: 425-240-7
CAS number: -
A screening for developmental and reproduction toxicity was
conducted according to OECD TG 421. 12 male and 12 female rats in each
dose group were administered daily via gavage the substance formulated
in 1% methylcellulose at doses of 0 (vehicle control), 100, 300 and 1000
mg/kg bw, starting 2 weeks prior to mating until scheduled necropsy.
Males were treated for a total period of at least 4 weeks (actually 36
days). Females were treated up to day 4-6 p.p, so that pre-mating,
mating, gestation and early lactation were covered by the treatment.
Investigations were performed on general tolerance of the test
compound by the parental animals as well as on effects on reproduction
including early postnatal development of F1 pups. The animals were
regularly observed and weighed, food intake and reproduction parameters
were determined. Selected organs were weighed and organs were subjected
to macroscopic and histopathological investigations.
All animals survived until scheduled necropsy. No toxicological
relevant findings were observed at daily cage-side or weekly detailed
clinical observations. Body weight and body weight gain and food intake
were comparable between compound-treated animals and controls. Necropsy,
organ weight analysis and histopathology did not reveal any relevant
No toxicological relevant effects were observed concerning the
insemination, fertility and gestation indices as well as the mean
duration of gestation and number of females with live born pups, mating
performance, number of implantation sites or prenatal losses, total
numbers of pups born, stillborn pups, the live birth index, percentage
of males born, the litter size at birth and the viability index.
No toxicological relevant findings were observed in F1 pups during
the five days lactation period, on pup weights at birth or on day 4 or
any macroscopical alterations with a remarkable incidence.
Overall, no indication for systemic availability could be
concluded from the study. The NOAEL was set 1000 mg/kg for general
toxicity of F0 animals, for reproduction toxicity and for developmental
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