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EC number: 604-195-9
CAS number: 1406-66-2
The test substance RRR-(alpha-, beta-, gamma-, delta)-tocopherol has not
been tested for toxicity to genetic material. There are a few studies
available concerning genetic toxicity of close homologs of the test
item. For further information please refer to the read-across
Bacterial reverse mutation assay:
In a bacterial reverse mutation assay (Ames test)
all-rac-alpha-Tocopheryl acetate produced negative results in 5
histidine-requiring strains (TA97, TA98, TA100, TA1535 and TA102.) of
Salmonella typhimurium, both in the absence and in the presence of
metabolic activation by an Arochlor 1254 -induced rat liver
post-mitochondrial fraction (S-9).
DL-alpha-Tocopherol was also negative in a bacterial reverse muation
assay in 2 histidine-requiring strains (TA 98, TA 100).
RRR-alpha-tocopherol was evaluated in an in vitro
mammalian chromosome aberration test according to Ishidate M Jr and
Odashima S (1977), Mutat Res 48:337. The frequency of chromosomal
aberrations was not significantly increased. No metabolic activation was
Vitamin E was tested in an in vitro cytogenetics assay. After exposure
to the test article the frequency of cells with structural or numerical
chromosome aberrations was not increased to a biologically relevant
extent. Positive and negative controls were valid.
It is therefore concluded that vitamin E is not clastogenic or
aneuploidogenic under the described experimental conditions.
Furthermore, the effect of dietary vitamin E (VE) on the bone marrow of
mice was investigated. For this purpose, mice received either a low VE
diet, a basal VE diet, or a high VE diet. Groups of male ICR mice were
fed a diet containing the test substance at concentrations of 0, 30, or
1000 ppm (corresponding to doses of ca. 0, 6, or 200 mg/kg bw/d,
respectively) for up to 50 weeks. Reticulocytes from blood samples
collected at various time intervals were used for micronucleus analysis.
The incidence of reticulocytes containing MNs did not increase in the
low VE diet group and did not decrease in the high VE diet group when
compared with the basal VE diet group. There were no statistically
significant intergroup differences at each time point.
Mammalian cell gene mutation:
A close homolog of the test item, D-gamma-tocopherol” was tested for
gene mutation in mammalian cells according to Tindall KR and Stankowski
LF (1989). Mutat Res 220: 241-253. The test substance had no effect on
mutant frequency. A significant decrease in cloning efficiency was
observed at the high concentration when compared with
controls; relative cloning efficiency was approximately 85-90% (control
= 100%). No metabolic activation was done.
RRR-(alpha-, beta-, gamma-, delta)-Tocopherol, is evaluated on the basis
of data on close homologs. On the basis of these results, there is
currently no indication of a potential for toxicity to genetic material.
The available data on genetic toxicity does not meet the criteria for
classification according to Regulation (EC) 1272/2008, and are therefore
conclusive but not sufficient for classification.
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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