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: 483-980-6
CAS number: -
This study was conduced to provide
initial information concerning possible effects of Vegeflux Soy on
reproduction and/or developmental when administered orally, by gavage,
to male and female rats using an OECD 421 protocol (according to GLP).
The Wistar rats, 48 adult males and 48
adult females were divided to four groups.Vegeflux Soy was administered
at doses of 200, 500 and 1000 mg.kg-1in olive oil; the
control group of rats received the vehicle at an equivalent volume. The
administered dose was calculated on the current body weight. Fixed
application volume 0.5mL/100g body weight was administered.
The males were treated 42 days: 14
days before the mating procedure, 14 days during the mating procedure,
and 14 days after the mating procedure. The females were exposed to
effect of Vegeflux Soy 41 – 51 days: 14 days before the mating
procedure, at most 14 days during the mating process, 22 - 24 days the
gestation, and 4 days during the lactation.
All animals were weighted weekly. The
litters were weighted 24 hours after the birth and on day 4
post-parturition. All animals were monitored for the signs of toxicity
during the application of the test substance. During study clinical
observation and food consumption were recorded. After finishing of the
test all animals were sacrificed and moved to the histological
evaluation. The results were elaborated in form of tables.
There was no test article-related
mortality of animals during the study. There were no clinical signs of
toxicity in all animals during observation period. The temporary
occurrence of alopecia and smooth stool in animals were registered. The
lethargy in three males (one male in each tested group except control
group) was registered, too. These incidences were not being indicated
relation to the test article treatment.
The body weight of all animals
moderately increased during the study. There were not significant
differences between of all tested groups and the control groups. The
food consumption in all animals was adequate.
After 8th day of beginning mating
procedure two males were replaced (one in dose group 500mg.kg-1, and one
in dose group 1000mg.kg-1). The length of pregnancy in all females was
22 – 23 days (in one female of dose group 500mg.kg-1 - 24 days).
Pup body weigh, external observation
and necropsy data were comparable among the groups. In litters of all
dose levels were not found any abnormal pups.
Copulation and fertility indices,
precoital intervals, gestation lengths and pregnancy rates were
comparable among the groups and no signs of prolonged delivery or
unusual nesting behaviours were noted.
The indices of reproductive parameters
in all dose groups against control group and number of corpora lutea and
implantation sites in all females were stable.
At termination of study in males of
control and highest dose groups left of epididymis for examination of
sperm parameters were used. Sperm comparative concentration, motility
and morphology were monitored. These parameters in highest dose group
against control group were comparable.
Detailed histological examination was
performed on reproduction organs of the males and females control and
highest dose groups. We have not seen pathological changes related to
the effect of Vegeflux Soy.
In all animals the kidney and liver
were evaluated as the possible target organs, too. In females of control
and highest dose group pathological changes related to the effect of
test article were not observed. In males significant increase of liver
relative weight in highest dose group, and degenerative (but not
necrotic) changes (nephropathy) of kidneys in all dose groups against
control group were observed.
(No-Observed-Adverse-Effect Level) for reproduction/developmental
parameters of males and females determined in this study is >
1000mg.kg-1 bw/day, excluding the findings of male rat nephropathy.
NOAEL (reproduction/developmental parameters of males and females) > 1000mg/kg bw/day (OECD 421, GLP, rat, gavage)
See section on fertility.
Based on the
classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS,
and given the absence of signs of toxicity up to the highest dose of
1000 mg/kg bw/d administered in rats by gavage in a reproduction
screening study (OECD 421, GLP), no classification for reproductive and
developmental toxicity is warranted according to the criteria of Annex
VI Directive 67/548/EEC or UN/EU GHS.
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.
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