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EC number: 217-589-7 | CAS number: 1897-52-5
- 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:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed in accordance with generally accepted scientific principles with a sufficient level of detail to assess the quality of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A single dose of test material was orally administered by gavage to groups of 5 mice and rats, of each sex, at 2.15 µL/kg to 2150 µL/kg of bodyweight in the mice experiment and 100 µL/kg to 2150 µL/kg of bodyweight in the rat experiment. All dose levels were brought to a volume of 10 ml/kg of bodyweight with 1% aqueous gum tragacanth. Following dose administration all animals were observed for a period of 14 days and any sign of intoxication ascertained by observation and manipulation was recorded.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,6-difluorobenzonitrile
- EC Number:
- 217-589-7
- EC Name:
- 2,6-difluorobenzonitrile
- Cas Number:
- 1897-52-5
- Molecular formula:
- C7H3F2N
- IUPAC Name:
- 2,6-difluorobenzonitrile
- Details on test material:
- Code No.: Postmus 74-85-01
Constituent 1
Test animals
- Species:
- other: mice and rats
- Strain:
- other: Swiss (mice); SPF Wistar (rats)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 16-20 g (mice); 200-220 g (male rats); 120-150 g (female rats)
- Fasting period before study: mice and rats were fasted overnight (18 hours) prior to dosing
- Housing: 5 per cage according to species, sex and dose level
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (ºC): 24 ºC
- Humidity (%): 60-75%
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gum tragacanth
- Details on oral exposure:
- DOSE VOLUME APPLIED:
10 ml/kg bodyweight administered as a standard dose volume - Doses:
- Mice (dose levels in µL/kg): 2.15, 4.64, 10.0, 21.5, 46.4, 100, 215, 464, 1000, 2150
Rats (dose levels in µL/kg): 100, 215, 464, 2150 - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations: following treatment any sign of intoxication which could be ascertained by observation and manipulation of the animals was recorded
Animal source: TNO., Zeist, The Netherlands
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 153.8 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 792.5 - 1 682.1
- Remarks on result:
- other: Mice experiment. Minimum symptomatic dose: 578 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 345.7 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 923.3 - 1 956
- Remarks on result:
- other: Mice experiment. Minimum symptomatic dose: 578 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 727.7 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 535.8 - 989.3
- Remarks on result:
- other: Rat experiment. Minimum symptomatic dose: 267.9 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 848.5 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 578.1 - 1 246
- Remarks on result:
- other: Rat experiment. Minimum symptomatic dose: 267.9 mg/kg
- Mortality:
- MICE EXPERIMENT
Following a single oral dose of 2150 µL/kg all five male and female animals died within 24 hours following dose administration. At the dose level of 1000 µL/kg three male and 2 female animals died within 48 hours following dose administration. All animals at all other dose levels survived the 14 day observation period.
RAT EXPERIMENT
At the dose level of 2150 µL/kg all dosed animals died between 24 and 48 hours following dose administration. At the dose level 464 µL/kg one male animal dies 72 hours after treatment. - Clinical signs:
- other: MICE EXPERIMENT Dose level 2150 µL/kg: Animals showed slowed down respiration rate, abnormal body posture and abnormal gait, loss of righting reflexes, mydriasis, loss of pinna and cornea reflexes, marked loss of body tone and grip strength, slight increa
Any other information on results incl. tables
Table 1: Mortality Results - Mice Study
Dose level (mg/kg bw) | No. Dead/ No. Treated (male) | No. Dead/ No. Treated (female) |
2678.9 | 5/5 | 5/5 |
1246.0 | 3/5 | 2/5 |
578.1 | 0/5 | 0/5 |
267.9 | 0/5 | 0/5 |
124.6 | 0/5 | 0/5 |
57.8 | 0/5 | 0/5 |
26.8 | 0/5 | 0/5 |
12.5 | 0/5 | 0/5 |
5.8 | 0/5 | 0/5 |
2.7 | 0/5 | 0/5 |
Table 2: Mortality Results - Rat Study
Dose level (mg/kg bw) | No. Dead/ No. Treated (male) | No. Dead/ No. Treated (female) |
2678.9 | 5/5 | 5/5 |
2678.9 | 5/5 | 5/5 |
578.1 | 1/5 | 0/5 |
267.9 | 0/5 | 0/5 |
124.6 | 0/5 | 0/5 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the condutions of the study, the highest fixed dose of the test material administered without causing any lethality was 578 mg/kg in the mice experiment and 267.9 in the rat experiment.The LD50 values were determined to be > 300 < 2000 in all cases.
- Executive summary:
The acute oral toxicity of the test material was investigated by administering a single dose of test material orally, by gavage, to groups of 5 mice and rats, of each sex, at dose levels of 2.15 µL/kg to 2150 µL/kg bodyweight in the mice experiment and 100 µL/kg to 2150 µL/kg bodyweight in the rat experiment. All dose levels were brought to a volume of 10 ml/kg of bodyweight with 1% aqueous gum tragacanth. Following dose administration all animals were observed for a period of 14 days and any sign of intoxication ascertained by observation and manipulation was recorded.
Under the conditions of the study, the highest fixed dose of the test material administered without causing any lethality was 578 mg/kg in the mice experiment and 267.9 mg/kg in the rat experiment. The LD50 values were determined to be > 300 < 2000 in all cases.
In accordance with the criteria for classification as defined in Annex I, Regulation No. 1272/2008, the test material meets the criteria for classification as 'Acute toxicity oral: Category 4' with the associated hazard phrase 'Harmful if swallowed (H302)'. This is equivalent to Xn (Harmful) with the associated risk phrase 'Harmful if swallowed (R22)' under Directive 67/548/EEC.
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