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EC number: 607-233-2 | CAS number: 2343-89-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/6/2015 to 6/5/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- methyl 2-fluoroprop-2-enoate
- EC Number:
- 607-233-2
- Cas Number:
- 2343-89-7
- Molecular formula:
- C4H5FO2
- IUPAC Name:
- methyl 2-fluoroprop-2-enoate
- Test material form:
- other: Light brown liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-Propenoic acid, 2-fluoro, methyl ester, EC Number: 607-233-2
- Physical state: Light brown liquid
- Analytical purity: 98.7%
- Lot/batch No.: 03026-20140801
- Expiration date of the lot/batch: 27 August 2015
- Storage condition of test material: Approximately 4 °C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test substance concentration in the dose samples was determined by HPLC with UV detection (HPLC-UV) using an external standard
- Duration of treatment / exposure:
- Up to 8 weeks (including a 2 week pre-pairing stage, pairing, gestation and early lactation for females)
- Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0.75 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 12 males and 12 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dose selection was based on the outcome of a 14 day range finding study.
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Immediately before dosing, up to 30 minutes post-dosing and one hour after dosing.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights will be recorded for males on Day 1 and then weekly until termination. Individual body weights will also be recorded at terminal kill. For females, individual body weights will be recorded on Day 1 and then weekly until pairing. During the pairing phase, females will be weighed daily until mating is confirmed. Mated females will be weighed on Day 0, 7, 14 and 20 post coitum and body weights for females which give birth will be recorded on Days 1 and 4 post partum. Body weights will also be recorded at terminal kill.
FOOD CONSUMPTION: Yes
- Time schedule: Male dietary intake will be recorded weekly prior to and after pairing. Female dietary intake will be recorded weekly prior to pairing. Food consumptions will not be performed during the pairing phase. Dietary intake for mated females will be recorded on Days 0-7, 7-14 and 14-20 post coitum. Food consumptions for females with live litters will be recorded between Days 1-4 post partum.
FOOD EFFICIENCY: Yes
- Time schedule: Weekly food conversion efficiency (body weight gain/food intake) will be calculated retrospectively for males and females prior to pairing, and for males after the pairing phase.
WATER CONSUMPTION: Yes
- Time schedule for examinations: Daily by visual inspection
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 42 (males) and Day 4 post partum (females).
- Animals fasted: No
- How many animals: 5 males and 5 females
- Parameters examined: Hemoglobin, Hematocrit, Erythrocyte count, Total leukocyte count, Differential leukocyte count, Erythrocyte indices (mean cell hemoglobin, mean cell volume, mean cell hemoglobin concentration), Prothrombin time, Activated partial thromboplastin time, Platelet count, Reticulocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Day 42 (males) and Day 4 post partum (females).
- Animals fasted: No
- How many animals: 5 males and 5 females
- Parameters examined: Blood Urea, Total Protein, Albumin, Albumin/Globulin ratio (by calculation), Sodium, Potassium, Chloride, Calcium, Inorganic phosphorus, Creatinine, Alkaline phosphatase, Alanine aminotransferase, Aspartate aminotransferase, Glucose, Total cholesterol, Total bilirubin, Bile acids
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Before the first exposure to the test item and once weekly thereafter.
- Dose groups that were examined: All test and control
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- ORGAN WEIGHTS: Yes
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Where considered appropriate, quantitative data was subjected to statistical analysis to detect the significance of intergroup differences from control; statistical significance was achieved at a level of p<0.05. Statistical analysis was performed on the following parameters: Grip Strength, Motor Activity, Body Weight, Body Weight Change, Food Consumption during gestation and lactation, Pre-Coital Interval, Gestation Length, Litter Size, Litter Weight, Sex Ratio, Corpora Lutea, I plantation Sites, Implantation Losses, Viability Indices, Offspring Body Weight, Offspring Body Weight Change, Offspring Surface Righting, Hematology, Blood Chemistry, Absolute Organ Weights, Body Weight-Relative Organ Weights.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No specific target organ or systemic toxicity was seen.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No changes were observed in male and female rats following dosing with the substance, when administered by oral gavage for 54 consecutive days at dosages of 0.75, 1.5 and 3 mg/kg bw/day. A 'No Observed Effect Level’ (NOEL) for systemic toxicity was considered to be 3 mg/kg bw/day (the highest dose employed).
- Executive summary:
In a subacute study the substance was administered to 12 rats/sex/dose by gavage at dose levels of 0, 0.75, 1.5 and 3 mg/kg bw/day for up to 8 weeks (including a 2 week pre-pairing stage, pairing, gestation and early lactation for females). There were no substance related effects in mortality, clinical signs, body weight, food and water consumption, haematology, clinical chemistry, behaviour, organ weights, or gross and histologic pathology. The NOEL is considered to be 3 mg/kg bw/day (highest dose employed).
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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