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EC number: 203-929-1
CAS number: 112-03-8
The mean achieved dosages of the test
substance for the dose-levels of 500, 2000 and 4000 ppm of test
substance were as follows:
- males (Days 1 to 106): 16, 61 and 123 mg/kg bw/d, respectively,
- females: during premating period (Days 1 to 71): 19, 74 and 154 mg/kg
during pregnancy period (Days 0 to 20 p.c.): 18, 69 and 145 mg/kg
during lactation period (Days 1 to 21 p.p.): 37, 159 and 326 mg/kg
- males (Days 1 to 120): 24, 96 and 202 mg/kg bw/d, respectively,
during premating period (Days 1 to 64): 32, 127 and 269 mg/kg
during pregnancy period (Days 0 to 20 p.c.): 21, 83 and 164 mg/kg
during lactation period (Days 1 to 21 p.p.): 41, 162 and 323 mg/kg
The actual intake of test substance for both males and females given
500, 2000 and 4000 ppm throughout the study is approximately
16-25, 61-101 and 123-208 mg/kg bw/d, respectively for the
F0 generation and 24-31, 96-123 and 202-252 mg/kg bw/d for
the F1 generation.
two-generation study, the read-across substance C12-16 ADBAC was
administered in the diet to male and female Sprague Dawley rats at 0,
500, 2,000, 4,000 ppm (purity 49.9%) i.e.:
500 ppm = 16-25 and 24-31 mg/kg
bw/day or 8-12.5 and 12-15.5 mg a.i./kg bw/day in males and females;
2,000 ppm = 61-101 and 96-123
mg/kg bw/day or 30.5-50 and 48 to 61.5 mg a.i./kg bw/day in males
4,000 ppm = 123-208 and 202-252
mg/kg bw/day or 61-104 and 101-126 mg a.i./kg bw/day in males and
test substance was administered before and throughout mating and
gestation until the end of the lactation period in both F0 and F1
generations. At 2,000 ppm, F0 (males) and F1 parents showed marginally
to slightly lower body weight gains and reduced food consumption.
Necropsy of parents of both generations revealed dilatation of the
caecum in some animals. This was associated with lower liver weights in
parental animals of both generations. At 4,000 ppm, in F0 and F1
parents, number of implantation sites and litter size at birth were
reduced. The progeny (F2) also showed lower pup weights. Pup weight gain
was slightly lower during lactation. Upon necropsy, dilatation of the
caecum with faeces was observed in 4/25 males and 2/25 females.
Treatment with the test substance had no effect on mating, fertility and
behavioural parameters in F0 and F1 parental Sprague-Dawley rats at
treatment levels up to 2,000 ppm. No effect was recorded on litter
parameters and on pre- and post-natal development of either generation
at 2,000 ppm. Consequently, under the experimental conditions of this
study, the NOEL for parental toxicity was 500 ppm for the male and the
female animals. The NOEL for mating behaviour, fertility and gestation
of each generation and for development, growth and survival of each
progeny was 2,000 ppm (61 to 101 mg/kg bw/day (nominal) (equivalent to
30.5 to 50.5 mg a.i./kg bw/day and 96 to 123 mg/kg bw/day (nominal)
(equivalent to 48 to 61.5 mg a.i./kg bw/day for the F0 and F1 generation
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