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EC number: 231-710-0 | CAS number: 7695-91-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
In a feed study DL-Alpha-Tocopheryl acetate was given to rats at 500, 1000 and 2000 mg/kg bw for 104 weeks (Wheldon, 1978). From this study it was concluded that the test substance has no carcinogenic effects.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
Justification for classification or non-classification
According to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 classification is not warranted.
Additional information
DL-Alpha-Tocopheryl acetate was fed to groups each consisting of 60 male and 60 female rats at dietary concentrations providing dosages of 500, 1000 and 2000 mg/kg body weight/day. Diet without test article served as control. After 52 consecutive weeks of treatment, ten males and ten females from each group were killed for histological examination. After 104 weeks of treatment, all surviving animals were killed.
During the first 14 weeks of treatment, prothrombin times were consistently prolonged in males (but not females) at all dosages. Persistent bleeding from minor trauma became a frequent occurrence among these animals, until the vitamin K intake was supplemented from the beginning of Week 24. All groups (including controls) received the same level of supplementation, via the drinking water (for the first three weeks) or the diet (subsequently).
Haemorrhagic incidents then declined within a few days, and prothrombin times resumed normal values. There were no other signs of reaction to treatment. Ophthalmoscopy revealed no treatment-related changes.
Impaired haemostasis contributed to the mortality among males receiving DL-Alpha-Tocopheryl acetate
at 1000 or 2000 mg/kg/day prior to vitamin K supplementation; five males died (or were killed in extremis) in each of these dosage groups during this period. A further death occurred at the highest dosage during Week 26, but infection rather than impaired haemostasis was causative.From Weeks 27 to 52, mortality was higher among control than treated males; the total mortality for both sexes displayed no relationship to dosage at the end of the 104 -week period.
At necropsy after 52 weeks of treatment, no treatment-related macropathology was discovered. Organ weight analysis indicated only inter-group differences that were secondary to differences in bodyweight.
Necropsy of animals dying during the second half of the study or killed after 104 weeks revealed higher liver weights (when expressed as a percentage of bodyweight) in females receiving 1000 mg/kg/day. Microscopic evaluation of liver sections revealed foamy macrophages in centriacini in most (60% or more) treated females and some 15% of the treated males. In a higher proportion of cases, these macrophages yielded positive reactions to Oil-Red-O and to the Per-iodic Acid Schiff technique. The inter-group distribution of this change was clearly related to treatment with the test article but was not related to dosage.
There were small but consistently dosage-related reductions in the incidence of mammary fibroadenomas in both sexes. With this possible exception, there was no evidence of any treatment related alteration of the tumour frequency in any tissue. Occasional cases of hepatic nodular hyperplasia were discovered in all groups, including controls, and their distribution was unrelated to dosage. Therefore, it was concluded that massive dosages of DL-Alpha-Tocoperyl acetate did not have tumorigenic effects.
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