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EC number: 214-787-5 | CAS number: 1194-65-6
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Dichlobenil
- EC Number:
- 214-787-5
- EC Name:
- Dichlobenil
- Cas Number:
- 1194-65-6
- Molecular formula:
- C7H3Cl2N
- IUPAC Name:
- 2,6-dichlorobenzonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately six weeks old
- Fasting period before study: overnight before first dose administration
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature: 22-24 °C
- Air changes: 16 per hour
- Photoperiod: 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 1 % tragacanth suspension
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosages were given as two equal administrations separated by a 24 hour interval in a volume of 0.1 mL/10 g body weight prepared in 1 % tragacanth suspension
- Duration of treatment / exposure:
- Two doses were administered over a 24 hour period
- Frequency of treatment:
- Two single doses were administered separated by a 24 hour period
- Post exposure period:
- Six hours after the second dose, the animals were sacrificed.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw (total dose)
- Dose / conc.:
- 600 mg/kg bw (total dose)
- Dose / conc.:
- 1 200 mg/kg bw (total dose)
- No. of animals per sex per dose:
- Five per sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - mitomycin C
- Doses / concentrations: 0.4 mg/mL in sterile buffered saline
Examinations
- Tissues and cell types examined:
- Femur bone marrow
- Details of tissue and slide preparation:
- Bone marrow was removed by injection of New Born calf serum into the femur. The serum and bone marrow suspension was centrifuged for 5 minutes at 800 rpm. The supernatant was removed and a bone marrow smear made from the pellet.
After air-drying overnight, the smears were fixed in methanol for 5 minutes and then successively placed in 1.25 % May-Grünwald for 15 minutes and in 3 % Giesma for 20 minutes. After rinsing in buffered distilled water, the slides were air-dried and mounted in Depex. - Evaluation criteria:
- Smears were examined to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes per animal and the ratio of normochromatic to polychromatic erythrocytes.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- All micronucleated cell counts for the test material were within the concurrent control range. The mean normochromatic/polychromatic ratio was 0.85
- Toxicity:
- no effects
- Remarks:
- No mortalities were noted in any of the doses administered
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No mortalities were observed.
At all dose levels, the mean micronucleated cell counts were in the same range as the counts obtained for the negative control group.
The mean ratios of normochromatic to polychromatic erythrocytes obtained for all dose levels were in the same range as those of the vehicle control group.
Any other information on results incl. tables
Table 1: Group mean results
Number of micronucleated cells per 1000 erythrocytes | Ratio of normochromatic to polychromatic erythrocytes | ||||
Material | Total dose (mg/kg) | Mean | Range | Mean | Range |
1% tragacanth | - | 0.2 | 0 - 1 | 0.85 | 0.56 - 1.51 |
Test material | 1200 | 0.2 | 0 - 1 | 0.92 | 0.58 - 1.61 |
600 | 0.8 | 0 - 3 | 0.77 | 0.58 - 1.02 | |
300 | 0.5 | 0 - 1 | 0.74 | 0.56 - 1.09 | |
Mitomycin C | * | 32.8 | 12 - 54 | 1.91 | 0.90 - 2.90 |
* 0.16 mg/animal
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the test material did not show any evidence of mutagenic potential for polychromatic erythrocytes of mice.
- Executive summary:
In a non-GLP compliant micronucleus test considered to be equivalent or similar to EU Method B.12, the genetic toxicity of the test material was determined.
No mortalities were observed. At all dose levels, the mean micronucleated cell counts were in the same range as the counts obtained for the negative control group. The mean ratios of normochromatic to polychromatic erythrocytes obtained for all dose levels were in the same range as those of the vehicle control group.
Under the conditions of this test, the test material showed no evidence of mutagenic potential for polychromatic erythrocytes of mice.
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