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EC number: 202-394-1 | CAS number: 95-14-7
In the present study toxic effects of the test item 1,2,3-Benzotriazole-REACH 01 at a
maximum dose of 200 mg/kg body weight on the development and reproduction of Wistar
rats after oral administration were under examination.
Mild discomfort throughout the whole application period was observed for the animals treated
with the high and the medium dose of the test item (wiping of nose and mouth through the
cage bedding, salivation after application, bleeding of mucous membranes at nose and
mouth, respirators sounds). A biological and particularly toxicological relevance of those
observations could not be excluded completely.
Regarding the body weight and the body weight gain, no significant differences were
observed between all test item treated animals (male and female) and their respective
vehicle control animals. Occasional differences observed for the females were assumed to
be of natural origin based on the pregnancy status of the animals.
The food consumption of the female animals was not effected by the administration of the
test item whereas the amount of water consumption was either enhanced (high and low dose
group) or reduced (medium dose group) when compared to the vehicle control animals. An
impact of the test item administration on the food and water consumption of the male animals
could not be observed.
The most prevalent findings during necropsy were reddened and swollen lymph nodes and
effects on the digestive system. All other findings were observed with low incidences and
without any test item related tendency. They were thus regarded to be spontaneous in
Histopathological examination of the ovaries as well as of the epididymides/testes did not
produce any evidence of pathomorphological findings that are considered to be due to a toxic
effect of the test item.
Regarding the reproduction and developmental parameters gathered in this study no
statistical significant changes were observed that were definitely treatment-related.
Reproduction success (achievement of pregnancy after indication of copulation, litter size
and survival rate of pups) was comparable between test item treated animals and the vehicle
control group. While the amount of live young born showed no significant differences in the
high dose group, the mean pup weight of the young born in this dose group was (although
not statistically significant) reduced compared to the vehicle control animals. Nonetheless, in
the absence of other findings regarding the developmental parameters a test item related
effect could be excluded with high probability.
A daily oral administration of the test item 1,2,3-Benzotriazole-REACH 01 to male Wistar rats
at dose levels of 12,5 mg, 50 mg and 200 mg/kg body weight over a time period of 39 to 50
days did not produce any pathological evidence for toxic effects on the reproduction
performance of male rats. However, an effects of the spermatogenesis may not have had an
adequate time to become evident (such as reduced sperm counts affecting the fertility) as
chemical exposure does not cover a complete cycle of spermatogenesis in male test
A daily oral administration of the test item to female Wistar rats at dose levels of 12,5 mg,
50 mg and 200 mg/kg body weight over a time period of 46 to 70 days did not produce any
pathological evidence for toxic effects on the reproduction performance of female rats
regarding the achievement of pregnancy, litter size and survival rate of pups.
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