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EC number: 220-778-7
CAS number: 2896-70-0
A 28-day repeated dose study was performed in accordance with EU Method
B7 and GLP, to assess the systemic toxicity of
2,2,6,6-tetramethyl-4-oxopiperidinooxy to Sprague-Dawley rats.
The test material was administered by gavage to three groups, each
containing five male and five female Sprague-Dawley rats for 28
consecutive days. The treatments were administered at doses of 15, 150
and 1000mg/kg/day. A control group was dosed with vehicle (Polyethylene
glycol 400). Two recovery groups of five male and five female animals
were treated with 1000mg/kg/day or the vehicle alone for 28 consecutive
days and then maintained without treatment for a further 14 days.
Clinical signs, bodyweight development, food and water consumption were
monitored during the study. Haematology, blood chemistry and urinalysis
were evaluated for all non-recovery animals at the end of the 28-day
treatment period and all recovery group animals at the end of the 14-day
treatment free period.
All animals were subject to a gross necropsy examination and
histopathological evaluation of selected tissues was performed.
There were no mortalities during the study. No
significant effects were observed in the body weights, food consumption
or water consumption. Animals treated with the test
material showed no adverse clinical signs that could be attributed to
toxicity of the test material.
Females in the 1000mg/kg/day treatment group showed statistically
significant reductions in haemoglobin, haematocrit, erythrocyte count
and mean corpuscular haemoglobin concentrations when compared to the
controls. No such changes were detected for males
treated with 1000mg/kg/day, or animals treated with 150 or 15 mg/kg/day.
Recovery group animals showed no haematological changes after 14 days
Neither the blood chemistry nor the urinalysis results showed any
treatment related effects.
The liver weights of males treated with 1000mg/kg/day was increased both
absolute and in comparison with the controls. Females
from the 1000mg/kg/day showed an increase in the relative and absolute
adrenal weights in addition to an increase in relative spleen weight.
No treatment related organ weight changes were detected in the 150 or 15
mg/kg/day dose groups after 28 days or in the recovery animals at the
end of the 14-day treatment free period.
In the 1000mg/kg/day treatment group, one male showed small pale areas
on the left lobe of the liver, whilst one female showed enlarged
adrenals at sacrifice.
No treatment related macroscopic abnormalities were detected for
recovery group animals or animals dosed with 150 or 15 mg/kg/day.
Centrilobular hepatocyte enlargement was observed for three male rats in
the 1000mg/kg/day dose group. In the recovery animals, regression of the
condition was observed after14 days without treatment.
No other evidence of treatment related morphological changes were
observed in the remaining treatment groups.
The test substance, 2,2,6,6-tetrametyl-4-oxopipeidinooxy, resulted in
toxicologically significant adverse effects when administered orally at
a dose level of 1000mg/kg/day for 28 consecutive days.
No effects were observed in the 15 or 150 mg/kg/day treatment groups
therefore the ’No Observed Effect Level’ (NOEL) was considered to be 150
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