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Diss Factsheets
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EC number: 206-466-3 | CAS number: 345-92-6
- 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 germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-11-11 to 2006-01-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Guideline for the testing of chemicals (China Environmental Science Publishing Company, May 2004) and The Test Method of Environmetal Chemical Carcinogenesis, Teratogenesis, Mutagenesis (Chen Xingruo et al. 1985)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4,4'-Difluorobenzophenone
- IUPAC Name:
- 4,4'-Difluorobenzophenone
- Details on test material:
- -supplier: ENVIRONMENTAL RESOURCE MANAGEMENT
-purity: 99%
-white powder
-long-term storage: normal temperature and humidity
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- age: 7 weeks (25-30 g)
supplier: Shanghai Animal Laboratory Animal Center; Chinese Academy of Science
Animal room environmental conditions
-temperature: 22+-4°C
-relative Humidity: 55+-10%
-illumination: natural lights
-individually housed in clean polycarbonate cages
- commercial diet and water ad libitum
-food and water standard met requirements for healthy growth of experimental animals
-cages and feeders changed and sanitized weekly
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- sojabean salad oil
- Duration of treatment / exposure:
- 2 consecutive days
- Frequency of treatment:
- once a day
- Post exposure period:
- 6 hours after second dosing
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600, 1200, 2400 mg/kg day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 male and 5 female animals per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide, 50 mg/kg day
Examinations
- Tissues and cell types examined:
- polychromatic and normochromatic erythrocytes of bone marrow
- Details of tissue and slide preparation:
- All animals were sacrificed by cervical dislocation 6 hours after second dose. Bone marrow from sternum was harvested. The marrow was evacuated from marrow canal by hemostat. A drop of the all marrow was placed on a clean microscope slide, using 0.2 ml fetal calf serum, and spread in the conventional manner. The smear was air-dried and fixed in 100% methanol for 10 min., and then stained with 2% Giemsa’s buffered solution (pH 6.8) for 25 min.
The slides were coded and at 100x magnification under a bright field in oil, 1000 polychromatic erythrocytes (PCE) were scored per animal, and the number of normochromatic erythrocytes (NCE) was also recorded simultaneously. - Evaluation criteria:
- The frequency of PCE and NCE with micronuclei was calculated for each animal and used to determine the mean value for the each group.
- Statistics:
- The results were evaluated by t test method, the difference was considered significant at P <0.05.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- see "Additional information on results"
- Vehicle controls validity:
- valid
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- The fur loosens, less movement and hyponoia were found in the high dose (2400mg/kg) after 2h of the second administration to the slide preparation. No significant toxic sign and death were found in other groups.
Any other information on results incl. tables
- Microscopic analysis
In female groups, the frequencies of PCE with micronucleus (MN) were 1.6-2.2‰, 1.8‰, 20.8‰ in 4,4-DIFLUORO BENZOPHENONE treated, negative control and positive control respectively. In male groups, the frequencies of PCE with micronucleus (MN) were 2.0-2.2‰, 2.0‰, 21.2‰ in 4,4-DIFLUORO BENZOPHENONE treated, negative control and positive control respectively. All those results showed no significant (P >0.05) increases in the frequency of PCE with micronucleus (MN), compared to the corresponding negative control. Furthermore, the frequencies of PCE and NCE in female and male groups treated with 4,4-DIFLUORO BENZOPHENONE were similar to those of the negative control, which was in 0.94-1.15 (between the normal range 0.6-1.2) respectively. The mice of positive control showed significant (P <0.01) increases in the frequency of PCE with micronucleus (MN) compared to the corresponding negative control.
- Body weight
No significant differences of body weight means were observed in any test or control group.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
From above data, it is concluded that cytogenetic activity of 4,4-DIFLUORO BENZOPHENONE in micronucleus test was negative. - Executive summary:
Bone marrow PCE micronucleus test of 4,4-DIFLUORO BENZOPHENONE was conducted with mice following “The Guideline for the Testing of Chemicals”(May 2004). Both male and female mice were treated with test material at 600, 1200, and 2400 mg/kg‧d, there was 10 animals with 5 males and 5 females in each group. Positive control (cyclophosphamide, 50 mg/kg) and negative control (soybean salad oil, CK) were performed at the same time with the method.
Mice were dosed oral for 2 times, dose interval was 24 hours. All mice treated with 4,4-DIFLUORO BENZOPHENONE showed no significant (P >0.05) increases in the frequencies of polychromatic and normochromatic erythrocytes with micronuclei compared to corresponding negative control. On the other hand, the mice treated with cyclophosphamide (CP) showed significant (P <0.01) increases in the frequency of PCE with micronuclei compared to corresponding negative control. The study suggested that Micronucleus test of 4,4-DIFLUORO BENZOPHENONE on bone marrow PCE in mice was negative.
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