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EC number: 604-195-9 | CAS number: 1406-66-2
- 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
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- Solubility in organic solvents / fat solubility
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- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles, please refer to IUCLID section 13 for read across justification.
Data source
Reference
- Reference Type:
- publication
- Title:
- Lack of Influence of a Long-Term High or Low Vitamin E Diet on the Oxidative Damage in the Bone Marrow of Mice.
- Author:
- Umegaki K et al
- Year:
- 1 997
- Bibliographic source:
- Int J Vit Nutr Res 67: 149-154.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Bone marrow samples at different times from week 4 to week 50. preparation and evaluation according OECD 474
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate
- EC Number:
- 231-710-0
- EC Name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate
- Cas Number:
- 7695-91-2
- IUPAC Name:
- 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-chromen-6-yl acetate
- Reference substance name:
- D,L-alpha-tocopheryl acetate
- IUPAC Name:
- D,L-alpha-tocopheryl acetate
- Details on test material:
- dl-alpha-tocopheryl acetate; no further data
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Clea (Tokyo, Japan)
- Age at study initiation: 4 weeks
- Weight at study initiation: ca. 18 g
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: propylene cages; no further data
- Diet: diet containing the test substance at concentrations of 0, 30, or 1000 ppm, ad libitum
- Water: tap water; ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- none
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): monthly
- Mixing appropriate amounts with (Type of food): Basal VE diet and high VE diet were prepared by adding 30 mg and 1000 mg VE to 1 kg of low VE diet (Low VE diet: 50% sucrose, 20% casein, 15% cornstarch, 5% stripped corn oil, 5% cellulose, 3,5% salt mixture (AIN76), 1% vitamin mixture (without VE), 0,3% DL-methionine and 0,2% choline bitartrate.)
- Storage temperature of food: -20 degrees C - Duration of treatment / exposure:
- 50 weeks
interim sacrifice at 6 weeks (5 males/group) - Frequency of treatment:
- continuously in the diet
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
ca. 0, 6, 200 mg/kg bw/d (0, 30, 1000 ppm in the diet, estimated with a conversion factor of 5)
Basis:
no data
- No. of animals per sex per dose:
- 13 males per group
- Control animals:
- yes, plain diet
- Positive control(s):
- not included
Examinations
- Tissues and cell types examined:
- peripheral blood reticulcytes
- Evaluation criteria:
- no data
- Statistics:
- Statistical analysis was made using one-way analysis of variance followed by Duncan's multiple range test. P values less than 0.05 were considered significant.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
Any other information on results incl. tables
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. Corresponding to the changes in the VE, lipid peroxidation in bone marrow was higher in the low VE diet group, but was not lower in the high VE diet group. Glutathione and vitamin C in the bone marrow, which were about 100-1000 times higher than that of VE, were not different among the groups.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test substance did not induce micronuclei in peripheral blood reticulocytes of male mice after administration at concentrations of 30 and 1000 ppm in the diet. - Executive summary:
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.
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