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: 219-956-7
CAS number: 2582-30-1
A reproduction/ developmental toxicity screening test was carried out in
order to assess the test material in accordance with the standardised
guidelines OECD 421 and EPA OPPTS 870.3550 under CLP conditions.
Four groups of ten male and female Wistar Han rats were exposed by oral
gavage to the test material at 0, 88, 300 and 1000 mg/kg bw/day in
carboxymethylcellulose. Males were exposed for 28 days
( 2 weeks prior to mating, during mating, and up to termination) and
females were exposed for up to 55 days ( 2 weeks prior to mating, during
mating and gestation and during at least 4 days of lactation).
Animals were evaluated for mortality/ viability, clinical and functional
observations, body weights and food consumption, clinical pathology,
macroscopy at termination, organ weights and histopathology on a
selection of tissues and reproduction/developmental parameters.
Severe clinical findings were observed in several females at 1000 mg/kg
throughout the gestation and lactation period including paresis of
hindlimbs, high stepping gait and piloerection. No
clinical signs directly related to the test item were observed in any
other group. The mating, fertility and conception indices, precoital
time and number of corpora lutea and implantation sites were unaffected
by treatment. However, the test substance adversely
affected the pre-and post-natal development off spring at 1000 mg/kg
bw/day which was evident by increased pre and post- natal mortality and
reduced pup weights. Furthermore, a significantly high
proportion of pups, across all treatment groups had microscopic and/or
macroscopic evidence of dissecting aneurysms. The mean
duration of gestation varied between 22.0 and 22.8 across all dose
groups. As the high dose value (22.8 days) is outside
the historical control range, the prolonged duration of gestation in
this dose group is considered to be treatment related.
Under the conditions of this study, the NOAEL for general systemic
toxicity for males was 300 mg/kg bw/day based on decreased food
consumption and body weights/ body weight change at 1000 mg/kg bw/day. For
females the NOAEL was 88 mg/kg bw/day as they showed decreased absolute
and relative thymus weights at 300 mg/kg bw/day in addition.
The NOAEL for fertility and reproductive performance was 1000 mg/kg
bw/day as no effects were seen on these parameters.
The NOAEL for developmental toxicity in the F1 offspring was not
determined, and a LOAEL of 88 mg/kg bw/day was calculated. Although
increased pre-and post-natal mortality and reduced pup weights were
evident only at 1000 mg/kg bw/day dose level, dissecting aneurysms were
detected in a dose-dependent fashion beginning at the lowest dose level
of 88 mg/kg bw/day.
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.
Tato webová stránka používá cookies, aby se vám naše stránky používaly co nejlépe.
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