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EC number: 606-729-6 | CAS number: 212386-71-5
- 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:
- April 12, 2016 - July 25, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (4-ethoxy-2,3-difluorophenyl)boronic acid
- EC Number:
- 606-729-6
- Cas Number:
- 212386-71-5
- Molecular formula:
- C8 H9 B F2 O3
- IUPAC Name:
- (4-ethoxy-2,3-difluorophenyl)boronic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at start of study: 9 weeks
- Weight at study initiation: 157- 179g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 23.4°C
- Humidity (%): 45.1-76.5%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From: day 1 To: day 15
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Methocel K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 and 30 g/L
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg: 3 (f)
300 mg/kg: 6 (f) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats treated with 2000 mg/kg were killed three hours after treatment in a moribund state. No mortality was seen in the rats treated with 300 mg/kg.
- Clinical signs:
- other: All rats treated with 2000 mg/kg showed locomotor disturbance and incomplete eyelid closure 15 minutes after treatment until they were killed. Additionally, piloerection and hunched position occurred 2 hours after treatment in all rats treated with 2000 m
- Gross pathology:
- All surviving rats were sacrificed at the end of the experimental part and all rats in moribund conditions were sacrificed by an air carbon dioxide mixture and exsanguination after opening the abdominal vessels (Vena cava caudalis, Aorta abdominalis). All rats were subjected to a gross pathological examination and macroscopic findings were noted manually on a necropsy protocol.
On decision of the responsible pathologist, the liver of animal no 4, 5 and 6 (prematurely killed rats dosed with 2000 mg/kg) were fixed in a 4% formaldehyde solution, processed to HE-stained slides and were subjected to histopathology. Histopathology findings were noted manually on the necropsy protocol.
The gross pathological examination revealed in prematurely killed rats dosed with 2000 mg/kg, a beige discoloration of the liver (animal no. 4, 5 and 6). Histopathology revealed no treatment-related lesions in the liver. No histomorphological findings that could be related to the beige discoloration were found. All other animals showed no macroscopic findings.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of the present study, the LD50 value for the test item is expected to be between 300 - 2000 mg/kg after single oral administration in rats.
- Executive summary:
Study Design
The study was started with 300 mg/kg in 3 female rats and continued stepwise with further 3 females treated with 2000 mg/kg and 3 females treated with 300 mg/kg.Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
Results
All rats treated with 2000 mg/kg were killed three hours after treatment in a moribund state. No mortality was seen in the rats treated with 300 mg/kg.
All rats treated with 2000 mg/kg showed locomotor disturbance and incomplete eyelid closure 15 minutes after treatment until they were killed. Additionally, piloerection and hunched position occurred 2 hours after treatment in all rats treated with 2000 mg/kg. No clinical signs of toxicity were observed in the rats treated with 300 mg/kg.
The body weight development was inconspicuous throughout the study.
The gross pathological examination revealed in prematurely killed rats dosed with 2000 mg/kg a beige discoloration of the liver (animal no. 4, 5 and 6). Histopathology revealed no treatment-related lesions in the liver. No histomorphological findings that could be related to the beige discoloration were found. All other animals showed no macroscopic findings.
Conclusion
Under the conditions of the present study, the LD50 value for the test item is expected to be between 300 - 2000 mg/kg bw after single oral administration in rats.
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