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EC number: -
CAS number: -
Five male and five female RccHan:WIST (SPF) rats were treated with FAT
40849/A TE at 2000 mg/kg by dermal application. The test item was
formulated in purified water at a concentration of 0.5 g/mL and
administered at a volume dosage of 4 mL/kg. The application period was
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 at
approximately 1, 2, 3 and 5 hours after treatment on day 1 and once
daily during test days 2-15. Local signs were noted once daily from test
day 2 to 15. Mortality/viability was recorded within the first 30
minutes and at 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.
No clinical signs were recorded in any of the animals throughout the
complete observation period.
Slight to marked blue staining produced by the test item was observed
immediately after removal of the dressing in all animals and persisted
on the treated skin area up to test day 8 in six animals, up to test day
12 in two animals and up to test day 15, the end of the observation
period, in two animals.
In all animals, the moderate blue staining prevented the assessment of a
possible erythema on test day 2 and 3. When assessable, only slight
erythema was noted in one animal between test day 7 and 10. Additionally
scaling was observed in the same animal between test day 8 and 10. No
local dermal sighs were observed in the other animals.
The body weight of the animals was within the range commonly recorded
for this strain and age.
No macroscopic findings were observed at necropsy.
The median lethal dose of FAT 40849/A TE after single dermal
administration to rats of both sexes, observed over a period of 14 days,
LD50 (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, FAT 40849/A TE does not have to be classified in respect
to the acute dermal toxicity study in rats.
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