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EC number: -
CAS number: -
Table 1. Group mean litter data
0 mg/kg bw/d
100 mg/kg bw/d
300 mg/kg bw/d
1000 mg/kg bw/d
Number females with live pups at Day 4 post-partum
Mean duration gestation (days)
Mean number implantation sites
Mean number pups born
Mean number pups alive Day 1
Mean % male pups Day 1
Mean number of pups alive Day 4
Post-implantation survival index %
Live birth index %
Viability index %
A combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test was conducted in male
and female Crl:WI(Han) rats, according to OECD Test Guideline 422. The
test material, TOFA_DimerFA_TETA_PAA, was administered orally by gavage.
A range-finding study was conducted with groups of 3 rats/sex. The test
material was administered daily by gavage for 14 days at dose levels on
0, 100, 300 and 1000 mg/kg bw/d. Based on the findings, dose levels of
100, 300 and 1000 mg/kg bw/d were selected for the main study.
In the main study, groups of 10 male rats were dosed once daily for two
weeks prior to pairing, during the pairing period and a further two
weeks before necropsy. Males were treated for a minimum of 6 weeks prior
to necropsy. Groups of 10 female rats were dosed for two weeks prior to
pairing, during pairing and until Day 4 post-partum, inclusive at total
of approximately 7 weeks. The females were allowed to litter and rear
their offspring to Day 4 post-partum.
There was no effect of test article administration on mating, fertility
or fecundity indices; the majority of animals mated within one oestrus
cycle. There was no adverse effect of treatment with
TOFA_DimerFA_TETA_PAA on gestational length, number of implantation
sites or pups born, pup survival or body weight gain. Pup necropsy data
were unremarkable. The no-observed-adverse-effect-level (NOAEL) for
reproductive and developmental toxicity was considered to be 1000 mg/kg
bw/d in males and females.
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