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EC number: 425-400-6 | CAS number: 179986-09-5
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, GLP, QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted May 26, 1983
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 425-400-6
- EC Name:
- -
- Cas Number:
- 179986-09-5
- Molecular formula:
- UVCB substance
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid
- Details on test material:
- - Physical state: liquid
- Analytical purity: 95%
- Storage condition of test material: room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9-mix from Phenobarbital/p-Naphthoflavone treated rats
- Test concentrations with justification for top dose:
- experiment I: 30-5000 µg/ml (with metabolic activation)
experiment I: 50-300 µg/ml (without metabolic activation)
experiment II: 30-5000 µg/ml (with metabolic activation)
experiment II: 50-200 µg/ml (without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubilty and its non-toxicity to the cells
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: cyclophosphamide (2.5 µM, with metabolic activation); ethylmethanesulphonate (4.8 mM, without metabolic avtivation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours with metabolic activation, 18 or 28 hours without metabolic activation
SPINDLE INHIBITOR (cytogenetic assays): colcemide (treatment of 2.5 h)
STAIN (for cytogenetic assays): Giemsa
NUMBER OF METAPHASES EVALUATED: 100 well spread metaphases per culture were scored for cytogenetic damage on coded slides.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A test article is classified mutagenic if it induces reproducibly either a significant concentration-related increase in the number of structural chromosome aberrations or a significant and reproducible positive response for at least one of the test concentrations. A test article producing reproducibly neither a significant concentration-related increase in the number of structural chromosome aberrations nor a significant and reproducibly positive response at any one of the test points is considered non-mutagenic in this system.
- Statistics:
- Fischer's exact test
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Remarks:
- some aberrations were noted but no statistically significant increases in the frequency of aberrations per cell or in the proportion of aberrant metaphases at any dose level evaluated with or without S9 Mix were observed.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without metabolic activation: mitotic indices were reduced to values below 60 % of the corresponding control in the evaluated cultures (at interval 18 and 28 h); with metabolic activation: mitotic index was slightly reduced at interval 28 h (about 30 %)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary of chromosomal aberration in V79 cells after treatement with test substance
Experiment |
Preparation interval (hours) |
S9 Mix |
Concentration in µg/ml |
Aberrant cells (incl./excl. gaps, exchanges, %) |
I |
18 |
- |
solvent control |
6.5 |
|
|
- |
50 |
16 |
- |
100 |
20 |
||
- |
300P |
3 |
||
II |
18 |
- |
solvent control |
5.5 |
|
|
- |
50 |
4.5 |
- |
100 |
8 |
||
- |
200 |
14 |
||
I |
28 |
- |
solvent control |
5.5 |
|
|
- |
300P |
9.5 |
II |
28 |
- |
solvent control |
5 |
|
|
- |
100 |
4 |
I |
18 |
+ |
solvent control |
5.5 |
|
|
+ |
30 |
7.5 |
+ |
100 |
5 |
||
+ |
300P |
11.5 |
||
+ |
5000P |
15.5 |
||
II |
18 |
+ |
solvent control |
3 |
|
|
+ |
30 |
4.5 |
+ |
100 |
2.5 |
||
+ |
300P |
5.5 |
||
+ |
5000P |
5.5 |
||
I |
28 |
+ |
solvent control |
3 |
|
|
+ |
100 |
13.5 |
+ |
5000P |
5.5 |
||
II |
28 |
+ |
solvent control |
4.5 |
|
|
+ |
100 |
5 |
+ |
5000P |
4 |
p: visible precipitation was observed
Applicant's summary and conclusion
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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