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EC number: 905-898-6
CAS number: -
Test substance stability:
The stability of test substance in rat diet
was demonstrated for a period of 32 days at room temperature in a
different batch of comparable quality, which was not used for the study.
The homogeneity of the mixtures was verified. The concentration control
analyses of the samples taken revealed that the values were within a
range of 90-110% of the nominal concentration in all analyses at all
time points, with the exception of one concentration in the feed of the
high-dose group (88%).
concentrations of 2 -aminoethanol were below 3 mg/kg for all control
animals, <3 - 4 mg/kg for the low dose animals, 8
- 11 mg/kg for the mid dose animals and 60
– 81 mg/kg for the high dose animals.
data of 2 -aminoethanol (calculated as 2 -aminoethanol
hydrochloride) from this
two-generation reproduction toxicity study show
a dose dependency of the plasma levels of 2 -aminoethanol in the
experimental animals and there with prove the bioavailability of 2
-aminoethanol hydrochloride in principle.
Under these conditions, no test
substance-related findings from clinical examinations or gross and
histopathology were observed, which indicate that the administration of
the test compound via the diet adversely affected the fertility or
reproductive performance of the F0 or F1 parental animals up to and
including a nominal dose of 300 mg/kg bw/d. Estrous cycle data, mating
behavior, conception, gestation, parturition, lactation and weaning as
well as sperm parameters, sexual organ weights and gross and
histopathological findings of these organs (including differential
ovarian follicle counts in the F1 females) were comparable between the
rats of all test groups.
high-dose level (1000 mg/kg bw/d), absolute and relative weights of
epididymides and cauda epididymidis were decreased and, in the F0
generation only, the number of homogenization resistant caudal
epididymal sperm was slightly, but significantly reduced. However,
histomorphological correlates for these findings were missing.
high-dose F0 and F1 generation females (1000 mg/kg bw/d), decreased
numbers of implants and increased resorption rates resulted in
significantly smaller litters, giving evidence for an adverse effect of
the test compound on fertility and/or reproductive performance at high
doses. It has to be noted that a dose of 1000 mg/kg bw/d also caused
beginning systemic toxicity in these females, as was indicated by
reduced food consumption and/or body weight gain during
All data recorded during gestation and
lactation in terms of embryo-/fetal and pup development gave no
indications for any developmental toxicity in the F1 and F2 offspring up
to a dose level of 1000 mg/kg bw/d. The test substance did not adversely
influence pup viability, body weight, sex ratio and sexual maturation.
Thus, under the conditions of the
present two-generation reproduction toxicity study, the NOAEL (no
observed adverse effect level) for fertility, reproductive performance
and systemic toxicity in parental F0 and F1 Wistar rats is 300 mg/kg bw/d.
The NOAEL for pre-and postnatal
developmental toxicity in their offspring is 1000 mg/kg bw/d.
substance intake (mg/kg bw/d; minimum value / maximum value)
Test group 01(100 mg/kg bw/d)
Test group 02(300 mg/kg bw/d)
Test group 03(1000 mg/kg bw/d)
94.3 (72.4 / 102.5)
283.2 (218.4 / 309.4)
943.3 (716.7 / 1032.6)
F0 females (premating)
96.7 (80.5 / 100.7)
289.6 (241.2 / 304.9)
964.4 (792.4 / 1017.8)
F0 females(F1 litter)- gestation period- lactation period*
103.5 (92.6 / 111.6)99.2 (81.6 / 120.2)
315.2 (284.8 / 337.9)306.7 (249.7 / 370.3)
1043.2 (989.4 / 1084.7)866.0 (668.6 / 1053.9)
* = Days 1–14 p.p. only
Compared to the controls (= 100%), the
following values (in %) were significantly changed (printed in bold):
100 mg/kg bw/d
300 mg/kg bw/d
1000 mg/kg bw/d
*: p≤0.05; **: p≤0.01
All other mean absolute weight
parameters did not show significant differences compared to the control
The decrease of absolute weights of
cauda epididymis, epididymides, and prostate in male top-dose animals
(1000 mg/kg bw/d) were considered as treatment-related effects.
The decrease of brain weights in
top-dose males (1000 mg/kg bw/d) as well as the increase of spleen
weights in low-dose females (100 mg/kg bw/d) was considered as
incidental and not treatment-related due to a missing dose-response
Compared to the controls (= 100%), the
following values (in %)were significantly changed (printed in bold):
1000 mg/kg bw day
All other mean absolute weight parameters did not show significant
differences compared to the control groups.
The decrease of absolute weights of cauda epididymis and
epididymides in male top-dose animals (1000 mg/kg bw/d) were considered
to be treatment-related.
The increase of absolute kidney weights of male and female animals
in mid- (300 mg/kg bw/d) and top-dose (1000 mg/kg bw/d) groups,
respectively, was statistically significant. Because no
histomorphological correlate was detected, a treatment-related weight
increase was less likely.
The decrease of spleen weights in top-dose males as well as the
increase of thyroid glands in top-dose males and mid- and top-dose
females, respectively, is considered incidental and not
treatment-related due to a missing dose-response relationship.
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