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Diss Factsheets
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EC number: 255-982-5 | CAS number: 42872-30-0
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: other: Test of clastogenicity and aneugenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1 March 2011 to 7 April 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline 487 but no reference on GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 487 dated 22 July 2010
- Principles of method if other than guideline:
- Micronuclei detected in the cytoplasm of interphase cells, result from either chromosome breakage leading to acentric fragments (clastogenicity) or impairment of the structure and/or function of the mitotic apparatus leading to lagging chromosomes (aneugenicity).
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 42872-30-3
- IUPAC Name:
- 42872-30-3
- Reference substance name:
- 2-(m-benzoylphenyl)propionitrile
- EC Number:
- 255-982-5
- EC Name:
- 2-(m-benzoylphenyl)propionitrile
- Cas Number:
- 42872-30-0
- Molecular formula:
- C16H13NO
- IUPAC Name:
- 2-(3-benzoylphenyl)propanenitrile
- Details on test material:
- Test article identification: BPPN
Test article batch number: F-CHN-090031-01
Certificate of analysis: dated 08 February 2011
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from the liver of Aroclor 1254-treated rats (final percentage of S9-mix in the culture medium:1.5%)
- Test concentrations with justification for top dose:
- With metabolic activation:
Range of concentrations tested in the culture medium: from 1 to 50 μg/mL.
The evaluated concentrations were 10, 20 and 25 μg/mL.
Without metabolic activation
Range of concentrations tested in the culture medium: from 1 to 600 μg/mL.
The evaluated concentrations were 10, 30 and 60 μg/mL. - Vehicle / solvent:
- dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- Without metabolic activation: Mitomycin C (MITC), 0.01 μg/mL With metabolic activation: Cyclophosphamide (CP), 1.5 μg/mL
- Details on test system and experimental conditions:
- L5178Y cells were treated with the substance in 96-well microtiter plates for 3 hours with metabolic activation and for 28 hours without metabolic activation. Without metabolic activation the cells were harvested directly after the treatment time and with metabolic activation 21 hours (recovery time) after the end of the treatment.
- Evaluation criteria:
- Experiment acceptance criteria
The experiment is considered valid when all the following criteria are fulfilled:
• the population doubling of the negative control is higher or equal to 1.5 but not higher than 2.2;
• the number of micronucleated cells per 1000 cells in the concurrent solvent control is lower than or equal to the acceptable upper value for historical solvent control data (99% percentile of our historical negative control data):
- 9 for 28-hour treatment without S9-mix;
- 11 for 3-hour treatment with S9-mix.
• the positive controls induce a marked increase in the number of micronucleated cells;
• at least three analyzable concentrations are scored;
• the highest concentration evaluated corresponds either to 5000 µg/mL (or 10mM), or to the solubility limit in the solvent, or to the lowest precipitating concentration in the culture medium or to 50% to 60% of cell cytotoxicity.
Test evaluation criteria
A test article is considered to induce a positive response in the in vitro micronucleus test if the two criteria listed below are fulfilled for at least one concentration:
• the test article induces a statistically significant increase in the number of micronucleated cells for a given concentration;
• for this concentration, this value is strictly above positive threshold value (99% percentile of our historical negative control data):
- 9 for 28-hour treatment without S9-mix;
- 11 for 3-hour treatment with S9-mix.
When none of the above criteria are fulfilled, the test article is considered negative.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- A significant increase in the number of micronucleated cells was observed at 20 and 25 μg/mL.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The top concentration retained for scoring 25 μg/mL (60% of cytotoxicity) corresponded to the required cytotoxicity (50% to 60%).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- No significant increase in the number of micronucleated cells was observed.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The top concentration retained for scoring 60 μg/mL (55% of cytotoxicity) corresponded to the required cytotoxicity (50% to 60%).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Additional information on results:
- Preliminary test
With metabolic activation (3-hour treatment and 21-hour recovery):
Range of concentrations tested in the culture medium: from 1 to 600 μg/mL.
The evaluated concentrations were 10, 20 and 30 μg/mL.
The top concentration retained for scoring 30 μg/mL (42% of cytotoxicity) was considered as corresponding to the required cytotoxicity (50% to 60%) as the slides presented damaged cells with vacuoles attesting for cytotoxicity.
Genotoxicity
A significant increase in the number of micronucleated cells was observed at the three concentrations.
Another test was performed to confirm this result.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation
Under the experimental conditions of this study, BPPN was found positive in the exploratory in vitro micronucleus test in mouse lymphoma cells in the presence of metabolic activation and negative in the absence of metabolic activation.
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