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EC number: 947-655-7
CAS number: -
Table 1. Fertility and Reproductive parameters
No. of females evaluated for pre-coital time
Mean precoital interval (days)
No. of females evaluated for fertility
Number of pregnant dams
Fertility index (%)
No. of females evaluated for gestation length
Gestation length (days)
Number of dams with live pups
Gestation Index (%)
Implantation sites (total)
Implantation sites (mean)
Number of pups at birth (total)
Number of pups at birth (mean)
Birth Index (mean %)
Birth Index (total# %)
Number of stillbirths
No. of dams with stillborn pups
Number of live born pups (total)
Number of live born pups (mean)
Live birth index (mean %)
Live birth index (total#1 %)
Pre-implantation loss (mean %)
Pre-implantation loss (total#2 %)
Post-implantation loss (mean %)
Post-implantation loss (total#3 %)
Number of runts
Number of malformed pups
# based on
the total No. of implantation sites and total No. of pups at birth
(alive and dead)
#1 based on
the total No. live born pups and total No. of pups at birth (alive and
#2 based on
the total No. corpora lutea and total No. of implantation sites
#3 based on
the total No. implantation sites and toal number of live born pups
The aim of the study was to obtain information on possible
effects of the test item on general toxicity, reproduction and/or
development according to OECD guideline 422. The test item was
administered orally by gavage to rats at dose levels of 100, 300
and 1000 mg active ingredient/kg bw/day. The application started two
weeks before mating on test day one and ended on the day or one day
before sacrifice. Day of sacrifice was on test day 37 for the male rats
and between lactation day 4 and 7 for the female rats.
Effects on the parental generation (general toxicity)
No test item-related premature death was noted
in any treatment group (100, 300 and 1000 mg test item/kg bw/day).
No signs of clinical toxicity were noted for the male and
female rats of the low and intermediate dose groups (100 and 300 mg test
item/kg bw/day). A slightly increased salivation was noted in one male
rat, no further signs of clinical toxicity were noted for the male and
female rats of the high dose group (1000 mg test item/kg bw/day). A
slight reduction in body weight was noted for the male and female rats
of the high dose group (1000 mg test item/kg bw/day). For the male rats
the reduction in body weight was noted from test day 8 (4.4%) until test
day 36 (5.5%) and for the female rats from gestation day 0 (7.6%) until
lactation day 4 (9.5%). The body weight at autopsy was reduced
Effects on reproduction parameters and organs
No test item-related influence
was noted on the reproduction parameters in any treatment group (100,
300 and1000 mg/kg bw/day).
Microscopic examination revealed no changes in the
reproductive organs from the male and female rats of the high dose group
(1000 mg/kg bw/day).
Effects on the F0-generation
(no-observed-adverse-effect level): 300
mg/kg bw/day, p.o.
Effects on reproductive
(no-observed-adverse-effect level): >=1000 mg/kg bw/day, p.o.
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