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EC number: 213-561-3
CAS number: 980-26-7
each of three female HanRcc:WIST (SPF) rats, were treated with the test
item (Pigment Red 122) by oral gavage administration at a dosage of 2000
mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a
concentration of 0.2 g/mL and administered at a volume dosage of 10
were examined daily during the acclimatization period and mortality,
viability and clinical signs were recorded. All animals were examined
for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours
after treatment on day 1 and once daily during test days 2-15. Mortality /
viability was recorded at approximately 30 minutes, 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
survived until the end of the study period.
were observed in all animals from test day 2 to 5 or test day 6. Three
out of 6 animals were noted with slightly ruffled fur from the
observation performed within the first 30 minutes after application to
the 2-, 3- or 5 -hour reading.
weight of the animals was within the range commonly recorded for this
strain and age.
the lungs was noted in one animal whereas no macroscopic findings were
recorded in the remaining five animals at scheduled necropsy.
lethal dose of the test item after single oral administration to female
rats, observed over a period of 14 days is:
(female rat): greater than 2000
the test item has not to be classified as acutely toxic by the oral
route according to Regulation (EC) No 1272/2008.
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