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EC number: 200-412-2 | CAS number: 59-02-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 18 November 1998 - 27 November 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD Test Guideline No. 471, 1997, under GLP Standards and QA, please refer to IUCLID section 13 for read across justification.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His-gene: Amino acid histidine - GC base pairs, and AT base pairs (TA102)
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: rfa, ¿uvrB
- Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: rfa, ¿uvrB; pKM101
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: rfa, ¿uvrB; pKM101
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: rfa, ¿uvrB; pKM101
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: rfa; pKM101, pAQ1
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 (from phenobarbital/ß-naphthoflavone treated male albino rats)
- Test concentrations with justification for top dose:
- 0, 50, 158, 500, 1580 and 5000 µg/plate
- Vehicle / solvent:
- - Solvent used: ethanol
- Justification for choice of solvent: The test compound was soluble in ethanol. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- Remarks:
- Migrated to IUCLID6: + S-9; 1.0 µg/plate
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: - S-9; 0.4 µg/plate; TA102
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: - S-9; 1.0 µg/plate; TA1535 and TA100
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: - S-9; 0.5 µg/plate; TA98
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- ± S-9; all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation modification assay
DURATION
- Preincubation period: 30 minutes
- Selection time (if incubation with a selection agent): 2 days
SELECTION AGENT (mutation assays): overlay agar containing Histidine
NUMBER OF REPLICATIONS: 3 plates per concentration (2 plates for positive controls)
NUMBER OF CELLS EVALUATED per culture: 100 µl of overnight culture (ca 10*8 cells) plated per plate
DETERMINATION OF CYTOTOXICITY
- Method: in a preliminary toxicity assay determination of reduction in the revertant colony number and/or observation of thinning or absence of the background lawn.
OTHER EXAMINATIONS:
- Other: A range finder assay with strain TA100 (standard plate incorporation version, ± S-9) was performed. - Evaluation criteria:
- A positive result is defined as a reproducible, dose-related increase in the number of his+ revertants. The increase should reach at least a doubling of the number of spontaneous revertants for Salmonella typhimurium strains TA1535 and TA98. For strains TA97, TA100 and TA102 a 1.5 - fold increase over control values might be indicative of a mutagenic effect provided the negative control values fall within the historical control data. Biological relevance should always be taken into account. A negative result is defined as the absence of a reproducible increase in the number of his+ revertant colonies.
- Statistics:
- Mean values and standard deviation (SD).
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak reduction of background growth at = 500 µg/plate (preincubation test, - S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: The mutant frequencies of the controls were in the range of the historical control values.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test compound did not induce any relevant increase of the number of revertant colonies/plate in any of the five tester strains.
Thus it can be concluded that all - rac a tocopheryl-acetate is not mutagenic in the Ames test under the described experimental conditions. - Executive summary:
all - rac a tocopheryl-acetate was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a preincubation modification assay were performed in absence and in presence of an exogenous metabolic activation system (S9). Five Salmonella typhimurium test strains (TA1535, TA97, TA98, TA100, and TA102) were employed. The activity of the S9-mix and the responsiveness of the test strains were verified by including appropriate controls into each experiment.
all - rac a tocopheryl-acetate was dissolved in ethanol. Upon addition of aliquots to the aqueous medium formation of milky suspensions was apparent already at concentrations (=50 µg/plate) and precipitation in the form of droplets occurred at = 500 µg/plate. Since toxic effects were generally not observed with the exception of a weak reduction of background growth in strain TA98 (preincubation test, - S9) the concentration range 50 to 5000 µg/plate, the generally recommended highest test concentration for non toxic compounds, could be evaluated.
No increase in the number of revertant colonies was apparent for any of the five test strains after treatment with all - rac a tocopheryl-acetate.
Thus it can be concluded that neither all - rac a tocopheryl-acetate per se, nor any of the metabolites formed is mutagenic in the Ames test under the described experimental conditions.
Reference
No remarks
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The test substance D-alpha-Tocopherol has not been tested for toxicity to genetic material. D-alpha tocopherol is tested negative for mutagenic potential in bacteria with a QSAR model program (OASIS TIMES).
There are two studies available concerning genetic toxicity of all-rac-alpha-Tocopherylacetate and DL-alpha-Tocopherol.
In a bacterial reverse mutation assay (Ames test) all-rac-alpha-Tocopherylacetate 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).
The test substance, D-alpha-Tocopherol, is evaluated on the basis of data on the close homologs "DL-alpha-Tocopherol" and "all-rac-Tocopherylacetate". On the basis of these results, there is currently no indication of a potential for toxicity to gentic material.
Justification for selection of genetic toxicity endpoint
Reliable guideline study is used for classification.
Justification for classification or non-classification
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.
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