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EC number: 220-778-7
CAS number: 2896-70-0
A GLP study was performed in accordance with OECD guideline 474 in order
to assess the potential of 2,2,6,6,-tetramethyl-4-oxopiperdinooxy to
produce damage to chromosomes or aneuploidy when administered to mice.
A range-finding study was performed to identify suitable dose levels and
route of administration.
The micronucleus study was conducted via the intraperitoneal route in
groups of 10 mice (five male/ five female) at the maximum tolerated dose
(MTD) 500 mg/kg and 250 and 125 mg/kg at the lower doses. The
test animals were sacrificed 24 or 48-hours after treatment, the bone
marrow extracted and smear preparations made and stained. Polychromatic
and monochromatic erythrocytes (PCE and NCE) were scored for the
presence of micronuclei. Further groups of mice were treated with a
single oral dose of arachis oil or cylclophosphamide to serve as vehicle
and positive controls respectively.
The results showed no significant increase in the incidence of
micronucleated PCE in animals dosed with the test material when compared
to the concurrent vehicle controls. No statistically
significant decrease was observed in the PCE/NCE ratio in either the 24
or 48-hour treatment groups when compared to the control. The
observation of clinical signs in the 500 mg/kg dose group and the
premature deaths observed in the 500 mg/kg 48 hour dose group were taken
to indicate that systemic absorption had occurred.
The positive control produced a marked increase in the frequency of
micronucleated PCEs demonstrating the sensitivity of the test system.
Under the conditions of the test, 2,2,6,6-tetramethyl-4-oxpiperidinooxy
was considered to be non- gentoxic.
Three GLP in vitro studies were included in the dossier. An Ames test
(Thompson, 2012) gave modest significant increases in the number of
revertant colonies at the high doses. Although a positive response was
obtained it can be considered to be a ‘weak’ positive.
An in vitro chromosome aberration study (Wright, 1997) gave positive
results observed mainly at the high doses only.
A mouse lymphoma study (Flanders, 2012) showed a weak positive response
at high doses.
Considering the results from the three in vitro studies a possible
clastogenic effect is indicated.
However two in vivo studies: a micronucleus study (Durward, 1997) and
comet assay in the liver and duodenum (Barfield, 2013), did not
reproduce the clastogenic effects of the in vitro studies. Both gave
conclusive negative results, therefore based on the available data,
2,2,6,6-tetramethy-4-oxopiperidinooxy is not considered to be
An in vivo study gave a conclusive negative response therefore no
classification is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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