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Diss Factsheets
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EC number: 619-079-3 | CAS number: 949109-75-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Phytosterol ester
- IUPAC Name:
- Phytosterol ester
- Details on test material:
- - Name of test material (as cited in study report): phytosterol esters
Composition as presented in report.
Sterol profile Composition of sample (%, w/w)
Cholesterol 0.2
Brassicasterol 2.9
Campesterol 26.7
Stigmasterol 17.7
β-Sitosterol 51.0
'Others' 1.5
Phytosterols (ex-Roche) were sourced from a variety of common edible vegetable oil distillates (mainly soya bean) and were dissolved in acetone. The phytosterols were then re-esterified with fatty acids from sunflower oils to form phytosterol esters, which were dissolved in acetone.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 1st and 2nd tests - 50, 100 and 200 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: The solvent was determined by the solubility of the substance in question and its suitability in the assay.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation 3 hr and 21 hr treatment respectively
Migrated to IUCLID6: 0.8 µg/ml and 0.4 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 20.0 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in suspension
ACTIVATION: Co-factor mix consisted of magnesium chloride, potassium chloride, buffer, glucose-6-phosphate and NADP giving a total of 10% S9 mix.
DURATION
- Exposure duration: 1st test +/-S9 3hr treatment and 18 hr recovery; 2nd test -S9 21 hr treatment, +S9 3 hr treatment and 18 hr recovery - Evaluation criteria:
- Evidence of mutagenic potential by a statistically and biological significant, dose-related increase in the percentage of cells with aberrations
- Statistics:
- Fishers exact test
Results and discussion
Test results
- Species / strain:
- other: human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- limited by solubility in the solvent
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
In vitro chromosome aberration assay in human peripheral blood lymphocytes
Concentration µg/ml |
Without S9 (Mean %) |
With S9 (Mean %) |
||||
Excluding gaps |
Including gaps |
Relative MI (%) |
Excluding gaps |
Including gaps |
Relative MI (%) |
|
1sttest |
3h treatment and 18h recovery |
|
||||
Solvent control |
1.0 |
1.0 |
100 |
0.5 |
1.5 |
100 |
50 |
1.0 |
1.0 |
91 |
2.0 |
2.5 |
88 |
100 |
0.5 |
0.5 |
80 |
0.0 |
0.0 |
87 |
200 |
0.0 |
0.0 |
68 |
2.5 |
3.5 |
88 |
Positive control |
20.0*** |
20.0*** |
- |
33.0 |
34.0*** |
- |
|
|
|
|
|
|
|
2ndtest |
21 h continuous treatment |
3h treatment and 18h recovery |
||||
Solvent control |
1.5 |
3.5 |
100 |
0.0 |
0.5 |
100 |
50 |
0.0 |
1.0 |
111 |
0.0 |
1.0 |
95 |
100 |
0.0 |
0.5 |
109 |
0.0 |
0.0 |
73 |
200 |
0.0 |
0.5 |
77 |
0.5 |
2.0 |
91 |
Positive control |
21.0*** |
21.0*** |
- |
21.0*** |
21.0*** |
- |
|
|
|
|
|
|
|
*** P<0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Phytosterol ester has been tested for clastogenicity in human peripheral blood lymphocytes, in a study which was conducted according to OECD 473, but not compliant with GLP. No evidence of a test-substance related increase in the number of chromosomal aberrations was observed with or without activation in the initial or repeat experiments. Appropriate solvent and positive controls were concluded and gave expected results. It is concluded that the test-substance is negative for mutagenicity to lymphocytes under the conditions of the test.
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