Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-253-5
CAS number: 68424-85-1
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/day, respectively,
during premating period (Days 1 to 71): 19, 74 and 154
mg/kg bw/day, respectively,
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/day, 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/day, respectively for the
F0 generation and 24-31, 96-123 and 202-252 mg/kg bw/day for
the F1 generation.
A study was conducted to determine the
toxicity to reproduction of the test substance (49.9% purity) according
to OECD Guideline 416, in compliance with GLP. In this two-generation
study, the substance was administered in the diet to male and female
Sprague-Dawley rats at dose levels of 0, 500, 2000 and 4000 ppm
(equivalent to 0, 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, 61-101 and 96-123 mg/kg bw/day or
30.5-50 and 48-61.5 mg a.i./kg bw/day in males and females and 123-208
and 202-252 mg/kg bw/day or 61-104 and 101-126 mg a.i./kg bw/day in
males and females, respectively). Doses were administered before and
throughout mating and gestation until the end of the lactation period in
both P0 and P1 generations. At 2000 ppm, P0 (males) and P1 (both sexes)
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 4000 ppm, in P0 and
P1 generations, number of implantation sites and litter size at birth
were reduced. The progenies (F1 and F2) also showed lower pup weights.
Pup weight gain was slightly lower during lactation. The weight of the
spleen was also reduced. Upon necropsy, dilatation of the caecum with
faeces was observed in 4/25 males and 2/25 females in F2. Treatment with
the test substance had no effect on mating, fertility and behavioural
parameters in P0 and P1 parental Sprague-Dawley rats at treatment levels
up to 2000 ppm. No effect was recorded on litter parameters and on pre-
and post-natal development of either generation at 2000 ppm. Under the
study conditions, the rat NOEL for parental toxicity was determined to
be 500 ppm for the male and the female animals. The rat NOEL for mating
behaviour, fertility and gestation of each generation and for
development, growth and survival of each progeny was established at 2000
ppm (61-101 mg/kg bw/day (nominal) (equivalent to 30.5-50.5 mg a.i./kg
bw/day and 96-123 mg/kg bw/day (nominal) (i.e. 48-61.5 mg a.i./kg bw/day
for the F0 and F1 generation, respectively)) (Foulon, 2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Tällä verkkosivustolla käytetään evästeitä parhaan mahdollisen käyttäjäkokemuksen varmistamiseksi.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again