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Diss Factsheets
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EC number: 700-591-1 | CAS number: 82203-23-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-08-08 - 2008-04-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP 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)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- EC Number:
- 700-591-1
- Cas Number:
- 82203-23-4
- Molecular formula:
- C20H20Cl2O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): DCBS
- Substance type: organic
- Physical state: white powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Kun-ming Mouse, SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 25—30g
- Assigned to test groups randomly: Yes
- Fasting period before study: no data
- Housing: Male and female mice were fed in separate cages (L46 X W31 xH20cm). The cages were changed twice each week.
- Diet (e.g. ad libitum):
Feed was offered freely throughout the study period.
- Water (e.g. ad libitum): Water was offered freely throughout the study period.
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 30—70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
IN-LIFE DATES: From: To: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: vegetable oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: 5000 mg, 2500mg, 1250 mg / 40 mL
- Amount of vehicle (if gavage or dermal): 40 mL - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
According to the doses design, 5000 mg, 2500 mg and 1250 mg of testing article were taken and then was-added with vegetable oil to 40 mL, misce bene for test.
The three doses of reagents, positive control (cyclophosphamide, 40mg/kg) and negative control (vegetable oil 20mL/kg) were administrated intragastrically respectively to the five groups, at a proportion of 0.4mL/20g weight. Animals from each group are sacrificed at 24, 36 and 48 hours after administration. - Duration of treatment / exposure:
- 24, 36 and 48 hours
- Frequency of treatment:
- gavage in one time
- Post exposure period:
- Animals from each group were sacrificed at 24, 36 and 48 hours after administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg, 2500mg/kg, 1250mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 15 male and 15 female
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: gavage
- Doses / concentrations: 40mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow from femora
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: no data
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Bone marrow is removed from femora of all animals and then made into slides with calf serum.
DETAILS OF SLIDE PREPARATION:
The slide is prepared, fixed and stained with Giemsa
METHOD OF ANALYSIS:
Record the number of PCEs(polychromatic erytrocytes) which contain micronucleus of the 2000 PCEs per mouse. Calculate the permil of the cells containing micronucleus. Count the 200 PCE as well and the NCE, calculating the PCE/NCE ratio. - Evaluation criteria:
- No data
- Statistics:
- Using chi-square criterion to analyze the micronucleus percent of each group with negative control group statistically
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: Negative control is the vehicle control
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- no preliminary test recorded
RESULTS OF DEFINITIVE STUDY
- the ratio of Micronucleus and PCE/ NCE of test group have no obvious difference comparing with negative control (vehicle control) group. And the positive control show obvious difference.
- The mouse weight change of the test group has no obvious differece comparing with negative control (vehicle control) group and positive control.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
No toxic effect of the test item was observed in the experimental conditions, therefore, the genetic toxicity of test item is considered to negative.
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