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EC number: 300-644-5
CAS number: 93951-21-4
In this limit test, Reactive Black 5, dissolved in distilled
water, was administered orally by stomach tube in a single daily dose of
1000 mg/kg body weight to a group of 20 pregnant female Wistar rats from
the 7th - 16th day of pregnancy. A simultaneous control group of the
same size received the vehicle without test compound. On the 21st day of
pregnancy, the dams were killed and delivered by caesarean section. The
foetuses delivered by caesarean section were then examined
morphologically for developmental disorders.
The studie showed that the repeated oral administration of
Reactive Black 5, at a dose of 1000 mg/kg body weight in the sensitive
phase of organogenesis for the conceptuses, did not lead to any
impairment of the general physical condition of the dams or impaired
intrauterine development of conceptuses.
The morphological examination of the foetuses with regard to stage
of development, outwardly detectable anomalies as well as anomalies of
the internal organs and the skeleton showed no indication of an
embryotoxic or teratogenic effect of the compound. The findings observed
are to be regarded as spontaneous in origin.
On the basis of the results of this limit test, the “no observed
adverse effect level” for Reactive Black 5 in rats following oral
administration lies at 1000 mg/kg body weight with regard to maternal
and embryofoetal toxicity and teratogenicity.
No teratogenic effect was observed.
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