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EC number: 604-636-5 | CAS number: 148477-71-8
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- not specified
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate
- Cas Number:
- 148477-71-8
- Molecular formula:
- C21H24Cl2O4
- IUPAC Name:
- 3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate
- Test material form:
- not specified
1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Details on species / strain selection:
- Standard laboratory species/strain
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- 0.5% aqueous Cremophor emulsion
- Details on exposure:
- Male and female mice received a single intraperitoneal administration of 800 mg/kg bw.
- Duration of treatment / exposure:
- Single intraperitoneal injection, with sampling at 16, 24 and 48 hours.
- Frequency of treatment:
- Single dose
- Post exposure period:
- The femoral marrow of groups was prepared 16, 24 and 48 hours after administration. Negative and positive controls were sacrificed 24 hours after administration.
Doses / concentrations
- Dose / conc.:
- 800 mg/kg bw/day (actual dose received)
- Remarks:
- intraperitoneal administration
- No. of animals per sex per dose:
- 20/sex
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide served as positive control; the dose was 20 mg/kg bw ip.
Examinations
- Tissues and cell types examined:
- Femoral bone marrow: polychromatic erythrocytes (PCEs)
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- After single intraperitoneal administration of 800 mg/kg bw, mice showed the following signs until sacrifice: apathy, roughened fur, spasm and eyelids stuck together. Their feeding behaviour
was normal. One of forty treated animals died during the test period. No symptoms were recorded for the control groups. No animals died in these groups.
The ratio of polychromatic to normochromatic erythrocytes was clearly altered by treatment with spirodiclofen at all time points.
No biologically or statistically significant variations existed between the negative control and the groups treated intraperitoneally with 800 mg/kg bw spirodiclofen with respect to the
incidence of micronucleated polychromatic erythrocytes.
Any other information on results incl. tables
Summary of the mouse bone marrow micronucleus assay with spirodiclofen
Group | Time point | |||||
16h | 24h | 48h | ||||
NCE:PCE1 | MnPCE2 | NCE:PCE1 | MnPCE2 | NCE:PCE1 | MnPCE2 | |
Vehicle control | - | - | 942 | 1.8 | - | - |
800 mg/kg bw | 2501 | 1.4 | 2166 | 1.9 | 2035 | 1.9 |
Positive control | - | - | 913 | 16.4 | - | - |
1 number of NCEs per 1000 PCEs
2 number of micronuclei/1000 PCEs
Applicant's summary and conclusion
- Conclusions:
- This study showed no evidence of micronucleus formation in the bone marrow of mice, with evidence of target tissue exposure.
- Executive summary:
Spirodiclofen was tested for clastogenic potential in the bone-marrow erythroblasts of male and female mice. Male and female mice received a single intraperitoneal administration of 800 mg/kg bw. The femoral marrow of groups were prepared 16, 24 and 48 hours after administration. Negative and positive controls were sacrificed 24 hours after administration. Cyclophosphamide served as positive control, the dose was 20 mg/kg bw ip. Spirodiclofen-treated mice displayed clinical signs including rough fur, apathy, spasms and eyelids stuck together; one mouse died. The PCE:NCE ratio was altered by treatment with spirodiclofen, demonstrating target tissue exposure. The incidence of micronucleated was unaffected by treatment with spirodiclofen. The positive control cyclophosphamide had a clear clastogenic effect, an increase in polychromatic erythrocytes with micronuclei, and thus proved the sensitivity of this test system. Spirodiclofen was therefore not clastogenic under the conditions of this assay. Conclusion: This study did not reveal evidence of a clastogenic effect of spirodiclofen in an in vivo system in mice.
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