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Diss Factsheets
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EC number: 904-790-6 | CAS number: -
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
- EC Number:
- 904-790-6
- Molecular formula:
- C28H48O; C29H50O; C29H48O
- IUPAC Name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- The test item MIXTURE OF PHYTOSTEROLS was assayed in the toxicity test at a maximum
concentration of 5000 µg/plate and at four lower concentrations spaced at approximately
half-log intervals: 1580, 500, 158 and 50.0 µg/plate. Precipitation of the test item, from
severe to slight, which did not interfere with the scoring, was observed at higher dose
levels both in the absence and presence of S9 metabolic activation. No toxicity or relevant
increases in revertant numbers were observed with any tester strain, at any dose level, in
the absence or presence of S9 metabolism.
On the basis of solubility results obtained in the preliminary toxicity test, in Main Assay I,
using the plate incorporation method, the test item was assayed with all tester strains at
the following dose levels: 1500, 750, 375, 188 and 93.8 µg/plate - Vehicle / solvent:
- acetone
Results and discussion
Test results
- Species / strain:
- other: all treated strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Additional information on results:
- No toxicity was observed at any dose level with any tester strain, in the absence or presence
of S9 metabolic activation.
As no relevant increase in revertant numbers was observed at any concentration tested, a
pre-incubation step was included for all treatments of Main Assay II. Due to the acetone
toxicity, the volume of vehicle or test item solution used in the preparation of each plate
was reduced to 20 µL, hence the test item was assayed at the maximum concentration of
1000 µg/plate and at five lower dose levels spaced by a factor of two: 500, 250, 125, 62.5 and
31.3 µg/plate.
Precipitation of the test item, from moderate to slight, which did not interfere with the
scoring, was observed at higher dose levels both in the absence and presence of S9 metabolic
activation. No toxicity or relevant increase in the number of revertant colonies was observed
in the pre-incubation assay, at any dose level, with any tester strain/treatment condition
combinations.
The test item did not induce two-fold increases in the number of revertant colonies in the
plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the
absence or presence of S9 metabolism.
Applicant's summary and conclusion
- Conclusions:
- The test item MIXTURE OF PHYTOSTEROLS does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
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