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EC number: 233-162-8 | CAS number: 10049-04-4
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 04-30-1984 to 05-14-1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed similarly to OECD guideline with acceptable deviations.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 479
- Deviations:
- yes
- Remarks:
- : in vivo study, no detail on the substance
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- sister chromatid exchange assay
Test material
- Reference substance name:
- Chlorine dioxide
- EC Number:
- 233-162-8
- EC Name:
- Chlorine dioxide
- Cas Number:
- 10049-04-4
- Molecular formula:
- ClO2
- IUPAC Name:
- Chlorine Dioxide
- Details on test material:
- - Name of test material (as cited in study report): chlorine Dioxide
- Physical state: Yellow liquid
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: assumed to be stable during the test (sponsor responsibility)
- Storage condition of test material: no data
- Other: received on 1984/04/26
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc. Indianapolis, Indiana, USA.
- Age at study initiation: 9 weeks
- Weight at study initiation: 29.74 g mean weight
- Assigned to test groups randomly: yes, under following basis: according to LBI Standard Operating Procedures (SOP) # 303: "Genetics -- Animal Randomization"
- Fasting period before study: no data
- Housing: up to 5 mice per cage
- Diet (e.g. ad libitum): ad libitum (Purina Laboratory Chow)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Vehicle: deionised water
- Details on exposure:
- Total volume applied: 0.15 to 0.41 ml i.p.
Dose applied: 9.04, 21.08, 28.02, 38.55 mg/kg
Approximately 1 h before dosing, all animals received subcutaneous implant of a ~50% paraffin-coated 50 mg BrdU tablet. - Duration of treatment / exposure:
- one single acute dose
- Frequency of treatment:
- Number of applications: 1
- Post exposure period:
- 26 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.680, 1.586, 2.113, 2.900 mg/mL
Basis:
nominal conc.
in the vehicle
- No. of animals per sex per dose:
- 5/group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Substance used as Positive Control: Cyclophosphamide
- Route of administration: by intraperitoneal injection
- Concentration: 10 mg/kg in 0.9% saline
Examinations
- Tissues and cell types examined:
- Tissue: Bone marrow
Number of animals: 5 per group
Number of cells: 25 per animal
Time points: 24 h after treatment
Type of cells bone marrow
Parameters: numbers of sister chromatid exchanges - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:cell cycle kinetics were evaluated from 100 metaphases cells per animal and the appropriate doses and termination times were determined.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
DETAILS OF SLIDE PREPARATION: Slides were stained by a modification of the FPG (Fluorescence plus Giemsa) technique of Perry and Wolff (1974). The slides wre stained in Hoechst 33258.
METHOD OF ANALYSIS: the slides were exposed to black-light from a 15 W tube at 60°C for the same time required to detect SCE (15-30 minutes)
OTHER: - Evaluation criteria:
- If an increase in SCE is observed, one of the following criteria must normally be met to assess the compound as positive:
- Two-fold increase: approximately a doubling in SCE frequency over the "background" (solvent and negative control) levels, at a minimum of three doses
-Dose response: a positive assessment may be made in the absence of a doubling if there is a statistically significant increase at a minimum of three doses and evidence for a positive dose response
In some cases, statistically significant increases are observed with neither a doubling or a dose response. These results are assessed according to repeatability, the magnitude of the response, and the proportion of the dose levels affected. - Statistics:
- The SCE data generated in this study were analyzed by a parametric Analysis of Variance statistical test (Sokal and Rohlf, 1969). Individual animal results will be used as data points in the analysis.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- but the doses tested are high enough (limit of toxicity at 40 mg/kg)
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: the target dose levels of 10, 20, 40 and 60 mg/kg chosen for the preliminary study were based upon toxicity information gathered from a previous study of mouse bone marrow aberrations. 4 groups of 3 male mice per group were dosed with the test compound.
- Solubility: no data
- Clinical signs of toxicity in test animals: one animal was found dead at 40 mg/kg prior to colchicine administration.
- Evidence of cytotoxicity in tissue analyzed: the test compound caused no delay up to and including the target dose level of 40 mg/kg. there was however considerable cell cycle delay at 60 mg/kg.
- Rationale for exposure: based upon the evaluation of cell cycle kinetics data, target doses of 10, 20, 30 and 40 mg/kg were selected for the actual study.
- Harvest times: 24 h after dosing
- High dose with and without activation: no data
- Other:
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): The SCE frequencies were not significantly increased in any of the dose groups relative to the negative controls and were within the range of historical controls. The positive control showed a strongly and significantly increased SCE frequency relative to control (see table 7.6.2/1). Chlorine dioxide did not induce significant increases in SCEs at any of the doses tested.
- Induction of micronuclei (for Micronucleus assay): not applicable
- Ratio of PCE/NCE (for Micronucleus assay): not applicable
- Appropriateness of dose levels and route: no data
- Statistical evaluation:
- other: All animals in the test group exhibited hyperactive behaviour immediately after dosing, but shortly thereafter resumed normal behaviour.
Any other information on results incl. tables
Table 7.6.2/1:Table summarizing SCE frequencies in animals exposedin vivoto chlorine dioxide
Treatment | Dose mg/kg | No. of animals | No. of cells scored/animal | Total no. of cells scored | SCE frequencyd x ± S.E. |
Deionized water | 13.29 | 4a | 25b | 92 | 3.89 ± 0.26 |
Cyclophosphamide | 10.00 | 5 | 25 | 125 | 13.15 ± 0.36* |
Chlorine dioxide | 9.04 | 5 | 25 | 125 | 3.50 ± 0.25 |
Chlorine dioxide | 21.08 | 5 | 25 | 125 | 4.74 ± 1.29 |
Chlorine dioxide | 28.02 | 4c | 25 | 100 | 3.73 ± 0.54 |
Chlorine dioxide | 38.55 | 5 | 25 | 125 | 5.02 ±0.80 |
* significantly greater than negative control, p0.01
aOne animal had cell cycle delay, all cells in M1
bOne animal only 17 cells were scored
cone animal died after dosing
dmean SCE frequency / animal constituted a data point
Applicant's summary and conclusion
- Conclusions:
- Chlorine dioxide is considered negative for inducing sister chromatid exchanges in male mice bone marrow under the test conditions.
- Executive summary:
In an in vivo genetic toxicity study, Sister Chromatid Exchange (SCE) frequencies were determined in bone marrow cells in ICR male mice exposed to Chlorine Dioxide administered intraperitoneally as an acute dose, at dose levels of 9.04, 21.08, 28.02, 38.55 mg/kg in deionised water.
Animals were killed at 26 h post implantation, the optimum time for detection of SCE and the cells collected from the bone marrow. M2 cells were scored for the frequency of SCE per cell.
Concurrent vehicle mice were considered as a negative control. Cyclophosphamide was used as a positive control and was administered by injection at 10 mg/kg in 0.9% saline.
Genotoxicity of Chlorine Dioxide was found to be negative to bone marrow cells in ICR male mice and no toxicity effects were found.
Positive controls induced the appropriate response.
The SCE frequencies were not significantly increased in any of the dose groups relative to the negative controls and were within the range of historical controls. The positive control showed a strongly and significantly increased SCE frequency relative to control. Chlorine dioxide did not induce significant increases in SCEs at any of the doses tested.
Under the test conditions, Chlorine dioxide is considered negative for inducing sister chromatid exchanges in male mice bone marrow.
This study is considered as acceptable as it satisfies with the requirements for Test Guideline OECD 479.
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