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EC number: -
CAS number: -
Toxicity to reproduction – Fertility
A reproductive/developmental toxicity screening test according to OECD
421 was conducted with the test substance in male and female rats
(Holalagoudar, 2012). The test substance formulated in sterile water was
administered once daily via oral gavage to 10 Wistar rats per sex and
group at dose levels of 100, 300, 1000 mg/kg bw/day, respectively. A
similar constituted group of animals received the vehicle only and
served as control. Treatment was performed during 14 days pre-mating and
14 days mating period in both male and in female rats, as well as during
gestation period and up to post-natal day (PND) 3 in female rats. During
the study period, no treatment-related mortalities and no predominant
clinical signs of toxicity were observed in parental animals of the
treatment groups compared to the controls. Furthermore, no effect on
food consumption and body weight was noted in treated groups when
compared with controls. Gross pathology of parental animals revealed
reddish discoloration of various organs (e.g. kidney, skin, and testis)
in a dose-related manner among all treated groups, which was considered
to be due to the specific red colour of the test substance. Other
macroscopic organ findings were very few and not regarded to be
treatment-related, including a yellow spot in the epididymis of 2/10
males of the control group and 1/10 male receiving 100 mg/kg bw/day,
which represented spontaneous spermatic granuloma(s). In males, a
statistically significant increase in absolute and relative organ weight
of prostate (including seminal vesicle with coagulating gland) was
observed at 1000 mg/kg bw/day. However, no corresponding microscopic
findings in prostate (including seminal vesicle with coagulating gland)
were observed at any dose level, thus the changes in prostate weight
were considered to be non- adverse. There were no treatment-related
effects observed in testes and epididymides weights of treated groups
compared to the controls. In females, no statistically significant
differences in the absolute and relative organ weight of reproduction
organs (ovaries, uterus with oviduct and cervix) were noted in treatment
groups compared with controls. In accordance with the observed
substance-related reddish discoloration of some organs at necropsy,
brown and red-brown pigments were observed in reproduction organs and
kidney as well as in a number of lymph nodes at microscopic examination.
However, in view of the low degree of severity observed and in the
absence of any changes indicating functional impairment of the organs,
the pigmentation was not considered to be of toxicological relevance.
There was no treatment-related effect observed on the duration of
gestation and pre-coital interval in the treated groups when compared
with controls. The copulation index, fertility index and viability index
in treated groups remained unaffected compared to the control. All
pregnancies resulted in normal births and therefore delivery index was
not affected in any treatment group. The mean number of corpora lutea,
implantation sites, and live pups born on PND 0 as well as the percent
pre-implantation loss and post-implantation loss in treated groups were
comparable to those of controls. There was no treatment-related effect
observed on total number of pups born, sex ratio, live pups, still birth
on PND 0 and total number of live pups and sex ratio on PND 4.
Furthermore, no treatment-related gross external findings were observed
in pups from the treated groups on PND 0 and 4. Based on the results of
this study, the NOAEL for developmental and maternal toxicity in rats
treated with the test substance was considered to be ≥ 1000 mg/kg bw/day.
NOAEL (developmental toxicity, rat, m/f) = 1000 mg/kg bw/day (OECD 421)
Based on the available data on reproductive toxicity, the test substance
does not meet the criteria for classification according to Regulation
(EC) No 1272/2008 or Directive 67/548/EEC.
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