Registration Dossier
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EC number: 202-216-2 | CAS number: 93-08-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Gene mutation in vivo toxicity study if the test chemical
- Author:
- Wild et al
- Year:
- 1 983
- Bibliographic source:
- Food and chemical toxicology
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Micronucleus assay was performed in NMRI mice to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- other: Micronucleus assay in mice
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material: 2'-acetonaphthone
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: lvanovas GmbH, Kisslegg
- Age at study initiation: 10 to 14 week old
- Weight at study initiation: No data
- Assigned to test groups randomly: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): standard chow (Altromin) ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Olive oil
- Justification for choice of solvent/vehicle: The chemical was soluble in olive oil
- Concentration of test material in vehicle: 0, 340, 681 or 876 mg/Kg
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- No data
- Duration of treatment / exposure:
- 0 and 24 hours
- Frequency of treatment:
- Once
- Post exposure period:
- 6 hours
Doses / concentrations
- Remarks:
- 0, 340, 681 or 876 mg/Kg
- No. of animals per sex per dose:
- Total: 16
0 mg/Kg: 4
405 mg/Kg: 4
809 mg/Kg: 4
1213 mg/Kg: 4 - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data available
Examinations
- Tissues and cell types examined:
- Bone marrow micronucleus were examined.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: No data
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 30 hrs
DETAILS OF SLIDE PREPARATION: The smears were stained according to the method of Schmid (1976)
METHOD OF ANALYSIS: increase in the number of micronucleus
OTHER: No data - Evaluation criteria:
- The smears were noted for micronucleated polychromatic erythrocytes.
- Statistics:
- Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: No data
- Solubility: No data
- Clinical signs of toxicity in test animals: No data
- Evidence of cytotoxicity in tissue analyzed: No data
- Rationale for exposure: No data
- Harvest times: No data
- High dose with and without activation: No data
- Other: No data
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data
- Induction of micronuclei (for Micronucleus assay):Yes
- Ratio of PCE/NCE (for Micronucleus assay): Refer table below
- Appropriateness of dose levels and route: Intra-peritoneal
- Statistical evaluation:No data
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not produce genetic effects in a micronucleus assay performed in NMR1 mice and hence is not likely to classify as a gene mutant in vivo.
- Executive summary:
Gene mutation toxicity was performed to determine the mutagenic nature of the test chemical in vivo. Micronucleus assay was performed using bone marrow smears of male and female NMRI mice. The test chemical was dissolved in olive oil and used at dose levels of 0, 340, 681 or 876 mg/Kg. The chemical was given intraperitoneally during the 24 hrs study period. The mice were killed and bone-marrow smears were prepared 30 hr after treatment. The smears were stained according to the method of Schmid (1976) and were observed for genetic effects in polychromated erthrocytes. As seen by the results, the test chemical did not produce genetic effects in the micronucleus assay performed in NMR1 mice. Hence, it is not likely to classify as a gene mutant in vivo.
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