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EC number: 401-210-9 | CAS number: 83708-14-9 BEHENYLKETENDIMER; HERCULES PMC D-532; PMC D-532
- 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 / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 May 2004 - 24 August 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent study performed according to OECD 473 (1997) and GLP principals.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- PMC D-532
- IUPAC Name:
- PMC D-532
- Test material form:
- other: waxy solid
- Details on test material:
- - Name of test material (as cited in study report): PMC D-532
- Physical state: waxy solid
- Analytical purity: 86.9% w/w
- Lot/batch No.: 30GT0982
- Expiration date of the lot/batch: 4.8.08
- Stability under test conditions: Stable
- Storage condition of test material: Ambient temperature in the dark
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human peripheral blood lymphocyte
- Details on mammalian cell type (if applicable):
- Human blood samples from healthy, non-smoking donors
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver-derived metabolic activation system (S9-mix)
- Test concentrations with justification for top dose:
- 50, 300 and 600 micro g/mL (with and without S9) were treated. No analyses of stability, homogeneity or achieved concentration were carried out on the preparations of the test or positive control substances either prior to or after addition to the human peripheral blood lymphocyte cultures.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Exposure duration: 3 hours in the presence and absence of S9-mix and 20 hours in the absence of S9-mix
- Fixation time (start of exposure up to fixation or harvest of cells): 68 hours after the start of treatment (without and with S9).
NUMBER OF REPLICATIONS: 2 in two independent cytogenetic tests
NUMBER OF CELLS EVALUATED: 100
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: No
- Determination of endoreplication: No - Evaluation criteria:
- Data were summarized in tables showing the number of cells scored, the types of aberrations found, the frequencies of aberrations per cell and the percentages of cells bearing aberrations. The Fisher Exact Probability Test (one-sided) was used to evaluate statistically the percentage of metaphases showing aberrations (excluding cells with only gap-type aberrations).
Results and discussion
Test results
- Species / strain:
- lymphocytes: human peripheral blood lymphocyte
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: ca 7
- Effects of osmolality: ca 270 mmol / kg
- Precipitation: The highest concentration selected for chromosomal aberration analysis was the highest practicable concentration. Precipitation of the test substance in the culture medium was noted in cultures treated with PMC D-532 at most of the concentrations tested and in some cases precipitated test substance was also visible on the slides.
No statistically or biologically significant increases in the percentage of aberrant cells, compared to the solvent control values, were recorded in cultures from either experiment treated in the presence of S9-mix or treated for 20 hours in the absence of S9-mix.
A small but statistically significant increase in the percentage of aberrant cells was observed in Experiment 1 at the lowest concentration treated for 3 hours in the absence of S9-mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that, under the conditions of this assay, PMC D-532 is not clastogenic to cultured human lymphocytes treated in vitro in either the presence or absence of S9-mix.
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