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Diss Factsheets
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EC number: 200-915-7 | CAS number: 75-91-2
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2009
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Report describes methodology employed to try to measure genotoxicity using the Comet Assay in nasal epithelial tissue in rats.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Study required under (EC) No 466/2008
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- genetic toxicity
Test material
- Reference substance name:
- Reference substance 001
- Details on test material:
- No test material was used. The method development is described.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- other: Not applicable
- Vehicle:
- other: Not applicable
- Details on exposure:
- Naive animals were used for method development.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Not applicable
- Post exposure period:
- Not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
other: Not applicable - naive animals only
- No. of animals per sex per dose:
- 9 animals
- Control animals:
- no
- Details on study design:
- Various enzymatic digestion procedures were used to isolate single cells from the nasal and tracheal epithelium including:
digestion with collagenase type IV for 30 or 40 min at 37°C or overnight at 4°C; combined digestion with collagenase type IV / collagenase type P and protease type XIV for 45 min at 37°C.
The resultant preparations were washed and cells recovered using centrifugation.
Cell viability as indicated by means of trypan blue exclusion was typically 60% to 83%. This compares with recent publications which recommend a minimal viability of at least 70% for the in vivo Comet Assay.
The number of viable cells recovered per animal from nasal epithelium (1-3.5x106 cells) and trachea (no detectable cells recovered) was less than expected. The yield of individual cells from nasal epithelium, while low, was nonetheless considered adequate for subsequent conduct of the Comet assay; the very low recovery from tracheal epithelium precluded further work.
The number of blood cells present was reduced by including additional washing steps.
Single cell gel electrophoresis revealed the presence of extensive DNA damage in nasal epithelial cells expressing better than 70% viability as assessed by trypan blue exclusion. In some cases bright background fluorescence was seen after ethidium bromide staining. In general only around 10% of the cells applied to the gel exhibited an intact DNA image, with a single (exceptional) preparation of cells showing around 50% intact DNA.
Examinations
- Positive control:
- Not applicable
Results and discussion
- Details on results:
- Several approaches were taken in order to obtain viable cell populations from the nasal turbinates of rats for the purposes of establishing a method for Comet Assay determination on the TBHP test material.
Viability ranged from 60-83% (acceptable criterion: 70%)
Hedgehogs: 44-49% (acceptable criterion = 20%)
Tail intensities: 13.2, 8.3 (acceptable criterion = 5)
Applicant's summary and conclusion
- Conclusions:
- The Comet Assay method was not successful in nasal epithelial tissues from the rat, due to unacceptable non-specific cell DNA damage and low cell viability.
- Executive summary:
An attempt was made to develop a method to generate local nasal epithelial tissue genotoxicity data using the Comet Assay in the rat. Through multiple attempts and variations on published methods, it was not possible to obtain cell suspensions of with viability and DNA stability which fell within acceptable quality standards from which to make an assessment of the hazards/risks of locally acting genotoxic agents in the nasal tissue.
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