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EC number: 429-600-4
CAS number: 1026988-42-0
BASISCH GELB 8511 was administered as an oily suspension to Wistar rats
over one parental (F0) generation by stomach tube at dosages of 2; 10 or
60 mg/kg body weight/day.
There were no indications from the clinical and pathological
examinations, that the administration had adverse effects on
reproductive performance or fertility of the F0 parental animals of all
substance-treated groups. Mating behavior, conception, gestation,
parturition, lactation and weaning as well as gross pathology were
similar between the substance-treated rats and the corresponding
controls. Most of the F0 parental rats proved to be fertile within the
scheduled mating interval. Only few male and female F0 parental rats had
to be reevaluated for fertility. With exception of one high dose female
fertility was confirmed for all of these animals. According to the
results of pathology no relevant gross lesions that may explain the
infertility of this female was noted. Therefore, with respect of the
results of scheduled mating and reevaluation of fertility the overall
conclusion was drawn that there were no substance-related effects on the
fertility of male and female F0 parental animals.
General effects in the F0 parental animals were limited to abnormal
clinical findings. Salivation and retching, both shortly after
treatment, were noted in all dose groups (more pronounced in males than
in females), whereas respiratory sounds, discolored urine and fur
smeared with urine were exclusively seen in male and female F0 parental
rats of the high dose group. However, although salivation and retching
(attempts to vomit the test substance) shortly after treatment were
associated to the mode of administration by gavage, these findings were
regarded to represent not a toxicologically relevant effect. The
discoloration of the urine was, however, related to the physical
properties of the test compound (dyestuff) indicative for systemic
availability but was not assessed as an adverse effect per se. The
respiratory sounds were probably due to an unintentional aspiration of
the test substance as a consequence of attempts to vomit as it was noted
in the previous subchronic toxicity study also (BASF 1999). Moreover, in
that study a histological correlate was found. Consequently, the
respiratory sounds in this study were also assessed as indication of an
affection of the respiratory system.
The premature deaths of one male rat of the mid dose group and of six
males of the high dose group were assessed to be not substance-related,
but they are the consequence of misgavage, probably due to the strong
defensive reaction noted in most of the animals of the high dose group.
The gross pathological evaluation yielded no indications for
substance-induced general, systemic toxicity in the F0 parental animals
in none of the male and female F0 parental animals of any group.
Substance-induced signs of developmental toxicity were not observed in
progeny of the F0 parents at any dose level.
Therefore,under the conditions of this study the NOAEL (no observed
adverse effect level) for reproductive performance and fertility is 60
mg/kg body weight/day for the F0 parental rats.
The NOAEL for general effects of the test substance is 10 mg/kg body
weight/day for the F0 parental males and females.
The NOAEL for developmental toxicity (growth and development of the
offspring) could be fixed at 60 mg/kg body weight/day for the F1 progeny.
Thus, indications for impaired reproductive performance and fertility or
for developmental toxicity were not observed up to the high dose of 60
mg/kg body weight/day.
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