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EC number: -
CAS number: -
Body Weight (g)
Day 1 (treatment)
Discoloration, black brown
planned necropsy; K killedin extremis, S spontaneous death
No clinical signs
Dark red eyes
Black to dark blue feces
slight (max. grade of 3), X noted
first 30 minutes and at approximately 1, 2, 3 and 5 hours after
No clinical signs
were evident in any animal during the acclimatization period.
Two groups, each consisting of three
female RccHan:WIST (SPF) rats, were treated with FAT 40849/A TE by oral
gavage administration at a dosage of 2000 mg/kg body weight. The test
item was formulated in purified water at a concentration of 0.2 g/mL and
administered at a dosing volume of 10 mL/kg.
The animals were examined daily
during the acclimatization period and mortality, viability and clinical
signs were recorded. All animals were examined for clinical signs within
the first 30 minutes and approximately 1, 2, 3 and 5 hours after
treatment on day 1 and once daily during test days 2-15.
Mortality/viability was recorded within the first 30 minutes and
approximately 1, 2, 3 and 5 hours after administration on test day 1
(with the clinical signs) and twice daily during days 2-15. Body weights
were recorded on day 1 (prior to administration) and on days 8 and 15.
All animals were necropsied and examined macroscopically.
No intercurrent deaths occurred
during the course of the study.
Slight sedation and slightly ruffled
fur were observed in all animals within the first 30 minutes after
treatment and the slightly ruffled fur persisted up to the 5-hour
observation (Group 2) or day 2 (Group 1). Dark red eyes were noted in
all animals at the 3- and 5-hour readings. Black to dark blue faeces
were noted at day 2 up to day 3 or 4.
The body weight of the animals was
within the range commonly recorded for this strain and age.
Black brown discolouration of the
kidneys was recorded in all animals at necropsy.
The median lethal dose of FAT 40849/A
TE after single oral administration to female rats, observed over a
period of 14 days, is:
LD50 (female rat): greater than
2000 mg/kg body weight
Based upon the classification
criteria according to the Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008, the test item is not
classified in respect to the acute oral toxicity study in rats.
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