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EC number: 213-561-3
CAS number: 980-26-7
The median lethal dose (LD50) of test item (Pigment Red 122) after a
single oral administration to female rats, observed over a period of 14
days, was greater than 2000 mg/kg body weight.
No mortality was observed after nose-only inhalation exposure to the
test item (Pigment Red 122) of male and female rats at the highest
technically achievable aerosol concentration of 3.055 mg/L for 4 hours.
Based on the lack of lethal effects, severe clinical symptoms indicating
a life-threatening or moribund state, and gross morphological
abnormalities, it may be reasonably assumed that the LC50 for the test
item is greater than 5 mg/l air.
Pigment Red 122 caused no mortality in male and female rabbits after a
single dermal application of 3000 mg/kg bw.
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.
The purpose of this study was to assess the
acute inhalation toxicity of the test item when administered to rats for
a single 4-hour period.
One group of five male and five female
albino rats [HanBrl:WIST(SPF)], was exposed by nose-only, flow-past
inhalation to the test item at mean aerosol concentrations of 3.055 ±
0.068 (n=5) mg/L air (gravimetrically determined). Two gravimetric
measurements of particle size distribution during the exposure produced
mass median aerodynamic diameters and geometric standard deviations
(GSD) of 2.83 µm (GSD 4.04) and 2.64 µm (GSD 3.93), respectively.
All animals were observed for clinical signs
and mortality during and following the inhalation exposure, i.e. over a
15-day observation period. Body weights were recorded prior to exposure
on test day 1, and during the observation period on test days 4, 8 and
15. All animals were sacrificed and necropsied on day 15.
The ranges of temperature, relative
humidity, oxygen content and particle size measured during the exposure
were satisfactory for a study of this type.
There were no spontaneous deaths.
All animals showed rales, decreased
spontaneous activity, hunched posture, tachypnea and ruffled fur on the
day of exposure and the two following days in individually variable
Four females showed a slight transient body
weight loss between Day 1 and Day 4. All other animals gained body
weight as expected.
There were no macroscopic pathology findings
in any of the animals.
In conclusion, at the highest technically
achievable aerosol concentration of the test item of 3.055 mg/L air,
none of the ten exposed animals died (LC0 = 3.055 mg/L). Based on the
lack of lethal effects or severe clinical symptoms indicating a
life-threatening or moribund state, it may be reasonably assumed that
the LC50 for the test item is likely to be greater than 5 mg/L air.
Therefore, the test item has not to be
classified as acutely toxic by the inhalation route according to
Regulation (EC) No 1272/2008.
mortality was observed at 3 g/kg and no unusual behavioral, systemic
reactions or gross
pathologic alterations were observed. Body
weight gains were within normal range of growth.
Neither in studies witn oral nor inhaltion nor dermal exposure any
adverse effects were observed at / above limit doses.
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