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EC number: 224-403-8 | CAS number: 4345-03-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- α-tocopheryl hydrogen succinate
- EC Number:
- 224-403-8
- EC Name:
- α-tocopheryl hydrogen succinate
- Cas Number:
- 4345-03-3
- Molecular formula:
- C33H54O5
- IUPAC Name:
- 4-oxo-4-{[2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-chromen-6-yl]oxy}butanoic acid
- Test material form:
- not specified
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- concentrations for all test strains: 100, 333, 1000, 3333, 10000 μg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-Aminoantracene, 4-nitro-o-phenyl- enediamine
- Details on test system and experimental conditions:
- S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Concentration denotes the the percentage of S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) that was added to cultures.
Strain: TA100 |
||
S9 Activation |
S9 Species |
Concentration |
No Activation |
N/A |
N/A |
30% RLI |
Rat |
30% |
30% HLI |
Hamster |
30% |
10% RLI |
Rat |
10% |
10% HLI |
Hamster |
10% |
Strain: TA1535 |
||
S9 Activation |
S9 Species |
Concentration |
No Activation |
N/A |
N/A |
30% RLI |
Rat |
30% |
30% HLI |
Hamster |
30% |
10% RLI |
Rat |
10% |
10% HLI |
Hamster |
10% |
Strain: TA97 |
||
S9 Activation |
S9 Species |
Concentration |
No Activation |
N/A |
N/A |
30% RLI |
Rat |
30% |
30% HLI |
Hamster |
30% |
10% RLI |
Rat |
10% |
10% HLI |
Hamster |
10% |
Strain: TA98 |
||
S9 Activation |
S9 Species |
Concentration |
No Activation |
N/A |
N/A |
30% RLI |
Rat |
30% |
30% HLI |
Hamster |
30% |
10% RLI |
Rat |
10% |
10% HLI |
Hamster |
10% |
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance is not mutagenic in the Salmonella typhimurium strains TA 97a, TA 98, TA 100 and TA 1535 in absence and presence of metabolic activation.
- Executive summary:
A study was conducted to determine the mutagenic potential of the test substance according to Bacterial Reverse Mutation Test. The test substance was examined using four strains of Salmonella typhimurium (TA 97a, TA 98, TA 100 and TA 1535). The test was performed in the presence and absence of S9-mix (Sprague-Dawley rat or Syrian hamster liver S9-mix induced by Aroclor 1254). 5 concentrations were used for all test strains: 100, 333, 1000, 3333 and 10000 μg/plate. Positive and negative controls were included in the study. No significant increase of the number of revertant colonies could be observed at any of the treatment concentrations. Under the study conditions, the test substance was not mutagenic in the Salmonella typhimurium strains TA 97a, TA 98, TA1 00 and TA 1535 in absence and presence of metabolic activation (NTP, 1985).
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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