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EC number: 202-708-7 | CAS number: 98-86-2
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February to June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Acetophenone
- EC Number:
- 202-708-7
- EC Name:
- Acetophenone
- Cas Number:
- 98-86-2
- Molecular formula:
- C8H8O
- IUPAC Name:
- 1-phenylethanone
- Details on test material:
- - Name of test material (as cited in study report): acetophenone
- Physical state: liquid
- Analytical purity: 99.36%
- Lot/batch No.: E 38/06
- Expiration date of the lot/batch:
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Arald Winkelmann
- Age at study initiation: minimum 7 weeks (6-12 weeks at start of acclimation)
- Weight at study initiation:
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: groups of 5
- Diet (e.g. ad libitum)
- Water (e.g. ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 55 +- 10
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: cotton seed oil
- Justification for choice of solvent/vehicle: solubility and relative non-toxicity
- Concentration of test material in vehicle: 10.3-51.5 mg/mL
- Amount of vehicle : 10 mL/kg bw - Frequency of treatment:
- single
- Post exposure period:
- 44 hrs; additionally 68 hrs fur a further negative control and high-dose group
Doses / concentrationsopen allclose all
- Dose / conc.:
- 515 mg/kg bw (total dose)
- Dose / conc.:
- 257.5 mg/kg bw (total dose)
- Dose / conc.:
- 103 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: i.p.
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- peripheral blood erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Dose selection based on preceeding study on toxicity for determination of MTD: MTD = 515 mg/kg bw/d after intraperitoneal application; doses correspond to 0.2-, 0.5- and 1-fold MTD
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
44 and 68 hrs after application
METHOD OF ANALYSIS:
at least 10,000 cells scored per animal - Evaluation criteria:
- Relative PCE = proportion of immature polychromatic erythrocytes among total number of erythrocytes
Criteria for positive results:
- dose-related increase of micronucleated erythrocytes
- biologically relevant increase of micronucleated erythrocytes for at least one of the dose groups
- according to OECD Guideline 422 a statistitically significant increase additionally to the biologically relevant increase - Statistics:
- Non-parametric Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Clinical signs of toxicity in test animals: at the MTD all treated animals showed reduction of spontaneous activity, prone position, apathy, palpebral closure, uncoordinated movements
- Evidence of cytotoxicity in tissue analyzed: yes, relative changes of PCE
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no increase for test substance
- Appropriateness of dose levels and route: yes, testing up to MTD
- Statistical evaluation: no significant changes
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
There were no increased incidences of micronuclei in mouse peripheral blood erythrocytes. - Executive summary:
No increased incidences of micronuclei were observed in mouse peripheral blood erythrocytes after single intraperitoneal application of dosages of 103, 257.5, 515 mg/kg bw corresponding to 0.2, 0.5 and 1.0 of the MTD. The test was performed according to OECD Guideline 474 with sampling times of 44 and 68 hrs.
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