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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12/5/15 to 2/6/15
- 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:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- 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:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harla Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 179.2 g (variation not exceeding ±20%)
- Fasting period before study: Overnight
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access to 1014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to main drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): Fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, twleve hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5 mg/ml
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: Arachis oil BP used as the test substance did not dissolve/suspend in distilled water
MAXIMUM DOSE VOLUME APPLIED: 50 mg/kg, 5 mg/ml. - Doses:
- An initial sighting test was conducted aty 300 mg/kg. However, the test animal was killed for humane reasons due to the occurence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Literature.
A dose of 50 mg/kg was than administeered. No mortality was recorded at this level. - No. of animals per sex per dose:
- 5 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing, and then daily. Individual body weights were checked on Day 0, Day 7 and Day 14 or at death.
- Necropsy of survivors performed: Yes
Results and discussion
- Preliminary study:
- An intial dosing of 300 mg/kg was used in one rat, however this animal was killed for humane reasons one day after dosing due to it showing a severe toxicological effect.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 50 - <= 300 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Outside of one death at the initial 300 mg/kg dose, no mortality was recorded.
- Clinical signs:
- other: Signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg were prostration, pallor of the extremities, pilo-erection, emaciation, decreased respiratory rate, labored respiration and hypothermia. There were no signs of systemic to
- Gross pathology:
- Pale liver and pale kidneys were noted at necropsy of the animal treated at a dose level of 300 mg/kg. No abnormalities were noted at necropsy of animals treated at a dose level of 50 mg/kg.
Any other information on results incl. tables
Table 1 Individual Clinical Observations and Mortality Data - 300 mg/kg
Dose level | Animal number and sex | Effects noted after dosing (hours) | Effects noted during period after dosing | |||
0.5 | 1 | 2 | 4 | 1 day | ||
300 mg/kg | 1 -0 Female | 0 | 0 | 0 | 0 | Prostration,Pallor of the extremities, Pilo-erection, Emaciation, Decreased respiratory rate, Laboured respiration, Hypothermia. Animal killed for humane reasons. |
Table 2 Individual Body Weights and Body Weight Changes - 300 mg/kg
Dose level | Animal number and sex | Body weight at day 0 | Body weight at death | |||
300 mg/kg | 1 -0 Female | 168 g | 160 6 g |
Table 3 Individual Necropsy Findings - 300 mg/kg
Does level | Animal number and sex | Time of death | Macroscopic Observations |
300 mg/kg | 1 -0 Female | Humanely killed Day 1 | Liver: Pale, Kidneys: Pale |
Table 4 Individual Clinical Observations and Mortality Data - 50 mg/kg
Dose level | Animal number and sex | Effects noted after dosing (hours) | Effects noted during period after dosing (days) | ||||||||||||||||
0.5 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
50 mg/kg | 2 -0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 mg/kg | 3 -0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 mg/kg | 3 -1 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 mg/kg | 3 -2 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 mg/kg | 3 -3 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 5 Individual Body Weights and Body Weight Changes - 50 mg/kg
Dose level | Animal Number and Sex | Body weight at Day | Body Weight Gain During Week | |||
0 | 7 | 14 | 1 | 2 | ||
50 mg/kg | 2 -0 Female | 198 | 218 | 228 | 20 | 10 |
50 mg/kg | 3 -0 Female | 172 | 189 | 181 | 17 | -8 |
50 mg/kg | 3 -1 Female | 170 | 170 | 200 | 0 | 30 |
50 mg/kg | 3 -2 Female | 178 | 174 | 181 | -4 | 7 |
50 mg/kg | 3 -3 Female | 178 | 185 | 193 | 7 | 8 |
Table 6 Individual Necropsy Findings - 50 mg/kg
Dose level | Animal Number and Sex | Time of Death | Macroscopic Observatrions |
50 mg/kg | 2 -0 Female | Killed Day 14 | No abnormalities detected |
50 mg/kg | 3 -0 Female | Killed Day 14 | No abnormalities detected |
50 mg/kg | 3 -1 Female | Killed Day 14 | No abnormalities detected |
50 mg/kg | 3 -2 Female | Killed Day 14 | No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 50 - 300 mg/kg.
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at dose levels of 300 mg/kg and 50 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in arachis oil BP, at a dose level of 50 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. The animal treated at a dose level of 300 mg/kg was killed for humane reasons, 1 day after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths noted at a dose level of 50 mg/kg.
Clinical Observations. Signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg were prostration, pallor of the extremities, pilo-erection, emaciation, decreased respiratory rate, labored respiration and hypothermia. There were no signs of systemic toxicity at a dose level of 50 mg/kg.
Body Weight. Two animals showed body weight loss or no gain in body weight during the first week with expected gain in body weight during the second week. One other animal showed expected gain in body weight during the first week but body weight loss during the second week. Two animals showed expected gains in body weight over the study period.
Necropsy. Pale liver and pale kidneys were noted at necropsy of the animal treated at a dose level of 300 mg/kg. No abnormalities were noted at necropsy of animals treated at a dose level of 50 mg/kg.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 50 - 300 mg/kg body weight (Globally Harmonized Classification System - Category 3).
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