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EC number: 206-479-4 | CAS number: 348-57-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to international accepted guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-bromo-2,4-difluorobenzene
- EC Number:
- 206-479-4
- EC Name:
- 1-bromo-2,4-difluorobenzene
- Cas Number:
- 348-57-2
- Molecular formula:
- C6H3BrF2
- IUPAC Name:
- 1-bromo-2,4-difluorobenzene
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Test item: Difluoro-bromo-benzene
CAS No.: 348-57-2
Batch No.: L39084N
Physical state: liquid
Colour: colourless
Active Ingredient Content (GC): 96.4 %
Storage: 2-8 °C, in a tightly closed container
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:(WI)Br rats
Source: TOXI COOP ZRT.
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8 weeks old in first, second, third and fourth step
Body weight range at starting (first step): 182 - 187 g
Body weight range at starting (second step): 175 - 192 g
Body weight range at starting (third step): 170 - 190 g
Body weight range at starting (fourth step): 186 - 194 g
Acclimatization time: 5 days in first step, 6 days in second step, 7 days in third step and 8 days in fourth step
Animal health: Only healthy animals were used for the study. Health status was certified by the study director.
Housing: Group caging (3 animals/cage)
Light: Artificial light, from 6 a.m. to 6 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi annui oleum raffinatum
- Details on oral exposure:
- A single oral administration - followed by a fourteen-day observation period - was performed by gavage.
Starting dose was selected on the basis of the available information about the test item DIFLUORO-BROMO-BENZENE (CAS 348-57-2).
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose (step 1; group 1) in three female rats. Since no animal died, the test was continued at 2000 mg/kg bw dose level (step 2; group 2) on further three female rats. Since two animals of group 2 died, the test was continued at 300 mg/kg bw dose level (step 3; group 3) on further three female rats. There was no death in third step, so three further female rats were treated with the same (300 mg/kg bw) dose (step 4; group 4). No animal died in the fourth step, too, so the test was finished.
All doses were formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 and 30 mg/mL. Formulations were prepared just before the administration and stirred continuously during the treatment.
The day before treatment the animals were fasted. The food but not water was withheld overnight. The food was given back 3 hours after the treatment. - Doses:
- 2000, 300 mg/kg bw
- No. of animals per sex per dose:
- 3 female/dose
- Control animals:
- no
- Details on study design:
- The observation period was 14 days. Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, 5 h and 6 h after the treatment and twice each day for 14 days thereafter.
The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
At the end of the observation period rats were sacrificed and necropsy were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Altogether two rats dosed at 2000 mg/kg DIFLUORO-BROMO-BENZENE (CAS 348-57-2) died during the study. No death occurred in group 1 (2000 mg/kg bw) single oral dose of the test item. All female rats in step 1 survived until the end of the 14-day observation period.
Two females of group 2 (step 2) died on Day 1. Both deaths seemed to be consequences of systemic toxic effect of the test item.
No death occurred at 300 mg/kg single oral dose of the test item. All female rats in step 3 and step 4 survived until the end of the 14-day observation period. - Clinical signs:
- other: In group 1 treated with 2000 mg/kg bw dose: Decreased activity (score -1; -2), abnormal gait (score +1; +2), incoordination (score +2) and piloerection (score +1; +2) were observed in all animals. Tremor (score +1) was detected in one animal. These sympto
- Gross pathology:
- Two rats out of 6 animals treated with 2000 mg/kg bw dose of the test item spontaneously died during the study.
Internal necropsy finding as pale kidneys was observed in all animals of group 1. This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Most likely the observation is a congenital anomaly. Moderate hydrometra was observed in one female of the group 1 is physiological finding and connected to the cycle of the animal. An internal necropsy finding as autolysis was observed in two animals of group 2, but it is normal physiological process after death. Pale kidneys were observed in one animal of group 2 and slight hydrometra was found in same female.
All animals treated with 300 mg/kg bw dose survived until the scheduled necropsy on Day 15. Pale kidneys were observed in two animals treated with 300 mg/kg bw dose (group 3) and in two animals treated with the same dose (group 4).
Any other information on results incl. tables
Groups |
Treatment |
Lethality |
|
Test item |
Dose (mg/kgbw) |
Females |
|
1 |
“DIFLUORO-BROMO-BENZENE” |
2000 |
0/3 |
2 |
“DIFLUORO-BROMO-BENZENE” |
2000 |
2/3 |
3 |
“DIFLUORO-BROMO-BENZENE” |
300 |
0/3 |
4 |
“DIFLUORO-BROMO-BENZENE” |
300 |
0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The method used is not intended to allow the calculation of a precise LD50 value.
The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423.
Hazard Category: Acute Tox. 4 - Executive summary:
Dose (mg/kg bw) Mortality (dead/treated) LD50 (mg/kg bw) GHS Category 300 0/6 between 300 and 2000 4
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