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EC number: 251-649-3
CAS number: 33704-61-9
A reproscreening study in accordance with OECD 421 was performed to
determine the reprotoxic/developmental toxic potential of Cashmeran.
Cashmeran was given orally in the diet to Wistar rats at 0, 150, 600 or
1875 mg Cashmeran/kg food during a premating period of 2 weeks and
during mating (1 week), gestation and lactation until postnatal day 4.
The homogeneity, stability and content of the test substance in the
diets were confirmed by analysis.
No treatment-related changes in appearance, general condition or
behaviour of the animals were observed. Mean body weight and body weight
change were slightly decreased in the high dose group of the male
animals. Also, food consumption was slightly decreased in this dose
group, in both male and female animals. The effects on body weight could
only partly be explained by the decrease in food consumption, therefore,
this effect was considered to be treatment-related.
Increased organ weights (kidney and liver) were observed in male rats at
the mid- and high-dose. At the low dose level also an increase was
observed, however, this increase was considered to be minimal. No
treatment-related effects on organ weight were observed in females.
Histopathologically, an increased incidence of basophilic tubules was
observed at the low-, mid- and high-dose. In the low- and mid-dose this
increase was considered not toxicologically relevant due to the high
incidence in the control and absence of increase in severity. Specific
assessment of alpha-2u-microglobulins did not demonstrate
treatment-related differences. Therefore it was concluded that no
histopathological changes were observed that could explain the increased
kidney weights in the treated animals.
No treatment related effects were observed in reproduction indices,
except for a statistically significant increase in pre-implantion loss
in the highest dose group. However, as this effect was mainly due to 2
females in this group and the mean pre-implantation loss was within the
historical control range, this effect was considered to be not related
to treatment. No treatment-related effects on pups were observed.
Based on the results, the NOAELparental is considered to be 150 mg/kg
food, corresponding to an overall intake of 9.76 mg/kg bw/d for males.
No effects were observed on fertility and the development. Therefore,
the NOAELfertility/developmental toxicity is 1875 mg/kg food,
corresponding to 115.24 mg/kg bw/d for males and 121.83 mg/kg bw/d for
females. Based on these results, Cashmeran is considered to be not
reprotoxic/toxic for the development.
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