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EC number: 220-778-7
CAS number: 2896-70-0
A GLP study was performed to assess the toxicity of
2,2,6,6-tetramethyl-4-oxopiperidinooxy when administered orally. The
study was performed in accordance with OECD guideline 401. Following
a range finding study, three groups of five fasted females were dosed
with a single dose of test material. The doses were administered as a
dispersion in water at levels of 1000, 1414 and 2000mg/kg/b w. An
additional group of five fasted males were treated with 2000mg/kg/bw in
order to illustrate that one sex was not more sensitive that the other. The
animals were observed for 14 days after dosing. All
animals were subject to a gross pathological examination.
All animals, male and female, in the high dose group died by day 4, two
animals in the 1414mg/kg/bw dose group died, one on day 1 and the other
day 4, no deaths were observed in the 1000mg/kg/bw group. Common signs
of systemic toxicity noted were ataxia, hunched posture, lethargy,
ptosis, decreased respiratory rate and laboured respiration with
additional signs or incidents of clonic or tonic convulsions,
pilo-erection, loss of righting reflex, occasional body tremors and
Surviving animals recovered two days after dosing except for one female
which appeared normal throughout the study. No abnormality was observed
with respect to weight gain.
Abnormalities noted at necropsy of animals that died during the course
of the study were haemorrhagic or abnormally red lungs, ark liver and
dark kidneys. No abnormalities were observed in animals that were
terminated at the end of the study.
The acute oral median lethal dose and 95% confidence limits were
calculated by the method of Thompson W R to be 1464 (1235 – 1735)
mg/kg/bw for females only.
The results are summarised in the tables below:
Body weights, dose volume and dermal reactions
Ear tag no/sex
area stained brown
area appeared dry
% rem %remaining – visual estimate of the amount
of material remaining on the skin, gauze and occlusive binding at 24
hours after the binding was removed.
Draize Dermal Scoring Code
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible)
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight 4
eschar formation (injuries in depth).
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by 2
Moderate edema 3
(raised approximately 1.0mm)
Severe edema (raised more than 1.0mm, 4
extending beyond the area of exposure)
Animal E1884-M had diarrhea and/or soiling of the anogenital area on
days 8 through 10. Animal E1892-F appeared lethargic on the day of
dosing but returned to normal by day 1.
A GLP study was conducted to assess the effect of 2,2,6,6-tetramethyl-4
-oxopiperindinooxy when applied dermally. Two New
Zealand white rabbits (one, male and one female) were treated with a
single dose of 2000mg/kg/bw of the test substance. After a contact
period of 24 hours the test substance was removed with distilled water.
The animals were observed 1, 2 and 4 hours post dose, once daily for 14
days for toxicity and pharmacological effects and twice daily for
mortality. Body weights were recorded pre-test, weekly
and at termination.
No mortalities were observed during the test period. Instances of
lethargy, diarrhea and soilng of the anogenital area were noted during
the observation period. Bodyweight changes were normal. Dermal
reactions were well defined on day 1, were slight to well defined on day
7 and absent to slight on day 14.
On the basis of the study results the LD50 was defined
The available data summarised above demonstrates that
2,2,6,6-tetramethyl-4-oxopiperidinooxy does not required classification
as toxic via the dermal route, according to Directive 67/548/EC (DSD) or
Regulation (EC) No 1272/2008. However, classification is required with
respect to the oral toxicity. According toRegulation (EC) No 1272/2008,
the classification ‘Acute toxicity 4, H302 Harmful if swallowed’ should
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