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Diss Factsheets
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EC number: 700-526-7 | CAS number: 1333488-95-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
- EC Number:
- 700-526-7
- Cas Number:
- 1333488-95-1
- Molecular formula:
- C12H7F2NO4
- IUPAC Name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-9 weeks for phase I, 5-6 weeks for phase II
- Housing: mobile rat cage racks, environmental enrichment and nesting material provided
- Diet: ad libitum
- Water: ad libitum
- Acclimation: yes, time period not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes per hour: 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.09.2005 To: 28.11.2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5% w/v carboxymethylcellulose in 0.1% polysorbate 80
- Details on exposure:
- EXPERIMENTAL DESIGN:
Phase I: confirmation of suitability of limit dose 2000 mg/kg bw
Phase II: main micronucleus test (dosing of test group, vehicle control group and positive control group)
PREPARATION OF DOSING SOLUTIONS:
A stock suspension of the test material was prepared in the vehicle. All test and positive control substance dosing preparations were prepared as close to the time of dosing as possible. Dosing volume was 10 mL/kg bw. - Duration of treatment / exposure:
- 24 or 48 hours
- Frequency of treatment:
- single oral dose
- Post exposure period:
- none
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
other: test material in vehicle
- Remarks:
- Doses / Concentrations:
20 mg/kg bw
Basis:
other: positive control cyclophosphamide in vehicle
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
other: vehicle control
- No. of animals per sex per dose:
- Test group: 10
Vehicle control group: 10
Positive control group: 5
(All groups consisted of males only) - Control animals:
- yes
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
The positive control substance was applied as a solution in sterile double deionised water.
Examinations
- Tissues and cell types examined:
- Bone marrow, immature erythrocytes
- Details of tissue and slide preparation:
- TISSUE PREPARATION:
Animals were killed by over-exposure to halothane followed by cervical dislocation. All animals treated with the test material were examined internally for abnormalities to organs/tissues.
SLIDE PREPARATION:
Femurs were removed and stripped clean of muscle. The iliac end of the femur was removed and a fine paint brush was rinsed with saline, wiped to remove the excess and wetted with a solution of albumin (6% w/v in physiological saline). The conditioned brush was dipped into the marrow canal and two smears were painted on an appropriately labelled clean, day microscope slide. This procedure was repeated to give 4 smears of marrow per slide.
The slides were air dried and fixed in solvent (methanol) for at least 10 minutes. The slides were dipped into phosphate buffer, then stained with a solution of acridine orange (0.125 mg/mL) for 1 minute, then placed in fresh phosphate buffer for 10 minutes and then again in fresh buffer for a further 15 minutes. After staining the slides were air-dried and wet mounted in buffer prior to analysis.
SLIDE ANALYSIS:
Slides were coded and scored blind. 2000 immature erythrocytes were examined for the presence of micronuclei for each animal. The slides were also examined for evidence of cytotoxicity by couting the ratio of immature to mature erythrocytes in a sample of 1000 erythrocytes. - Evaluation criteria:
- VALIDITY CRITERIA:
- vehicle control group mean should be within, or close to, the historical control range
- positive control group should show an appropriate increase in the incidence of micronucleated immature erythrocytes, compared to vehicle control values
CRITERIA FOR DATA EVALUATION:
- negative result if no significant increase in the incidence of micronucleated immature erythrocytes above concurrent vehicle control incidences or if a significant increase in the incidence of micronucleated immature erythrocytes above the concurrent vehicle control incidences but within the laboratory historical vehicle control range
- positive result if a significant increase in the incidence of micronucleated immature erythrocytes which is in excess of a three-fold increase when compared with both historical and concurrent vehicle control incidences
- an incidence of micronucleated immature erythrocytes which is significantly different from the concurrent vehicle control incidences, but less than 3-fold in excess of both historical and concurrent vehicle control incidences may require further evaluation
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No significant increases in the incidence of micronucleated immature erythrocytes, compared to the vehicle control values, were in any rats treated with the test item up to the maximum tolerated dose at either of the sampling times investigated.
The sensitivity of the test system was clearly demonstrated by the marked increases in the frequencies of micronucleated immature erythrocytes induced by the positive control substance cyclophosphamide.
Examination of the internal organs showed one animal had gas distened intestines.
Any other information on results incl. tables
Group |
Treatment |
Dose |
Mean incidence of MIE/1000 IE ± SD |
|
24 h |
48 h |
|||
1 |
Vehicle Control |
10 mL/kg bw |
2.3 ± 2.8 |
0.6 ± 0.4 |
2 |
Positive Control |
20 mg/kg bw |
61.5 ± 25.2 |
- |
3 |
Test item |
2000 mg/kg bw |
0.7 ± 0.6 |
1.1 ± 0.7 |
IE: immature erythrocytes
MIE: micronucleated immature erythrocytes
SD: standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under conditions tested, the test item is not clastogenic in the rat bone micronucleus test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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