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EC number: 212-298-1 | CAS number: 778-94-9
- 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:
- 15 Feb - 09 Mar 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 Dec 2001
- GLP compliance:
- yes
- Remarks:
- The test complied with the Principles of Good Laboratory Practices (GLP) of the Certification and Accreditation Administration of the People’s Republic of China (2013 revised edition).
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
- EC Number:
- 212-298-1
- EC Name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
- Cas Number:
- 778-94-9
- Molecular formula:
- C8H3F3N2O2
- IUPAC Name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF grade
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Liaoning Changsheng Biotechnology Co., Ltd., Liaoning, China
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 201.80 - 235.18 g
- Fasting period before study: overnight before and 3 - 4 hours after exposure
- Housing: 2 animals during acclimation, individually during testing period, in hanging stainless steel cages (L32.0 cm x W28.0 cm x H20.0 cm) affixed to racks
- Diet: SPF rat/mice maintenance feed (Liaoning Changsheng Biotechnology Co., Ltd. China); ad libitum (except night before treatment and 3 - 4 h after exposure)
- Water: grade-one reverse osmosis water prepared at testing centre; ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.65 - 23.30
- Humidity (%): 41.23 - 69.80
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From 15 Feb to 09 Mar 2019
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL in the 300 mg/kg bw dose group; 200 mg/mL in the 2000 mg/kg bw dose group; actual weighed sample quantity was 0.3015 g, 0.3007 g and 1.9999 g, in the first, second, and third step, respectively.
- Justification for choice of vehicle: mixes more evenly with test material
- Lot/batch no: FN2019/01/03
MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
DOSAGE PREPARATION:
Theoretical weighed sample quantity was calculated based on designed dose and required volume. After grinding, the test sample was weighed in an appropriate container. A suitable quantity of vehicle was added to the standard mark, magnetically stirred for at least three minutes, and labelled in preparation for use. All test sample solutions were used within 4 h. In order to ensure the uniformity of the test sample solution, prior to use, the test sample solution was stirred on a magnetic stirrer for at least five minutes, and it was stirred throughout the entire exposure process.
CALCULATION FORMULA:
test sample concentration (mg/mL) = dose (mg/kg)/exposure volume (mL/kg),
theoretical weighed sample quantity (g) = prepared volume (mL) x test sample concentration (mg/mL)/1000. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals per step:
300 mg/kg: 2 x 3 animals (step 1 and 2); total 6 animals
2000 mg/kg (step 3): 3 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were checked twice daily, morning and night, for dead and moribund animals and time of death was recorded. The animals were weighed at introduction, at grouping, the day of exposure (fasting), at day 7 and day 14 after exposure, and at death.
- Necropsy of survivors performed: yes: gross necropsy was performed on all exposed animals (including animals that died in the test period) and gross necropsy findings were recorded in detail for each animal. Macroscopic observation comprised the tissues, organs, and contents of the animal’s thoracic cavity and abdominal cavity.
- Clinical signs including body weight: Detailed observation was performed once within 30 minutes on the day of exposure and at one, two, and four hours. Subsequently, symptoms were observed once daily and observation continued for 14 days. All observation results were fully recorded and individual records were kept for each animal. Changes to animal fur, eyes, mucous membranes, respiratory system, circulatory system, and nervous system were observed and recorded in detail, with particular attention to changes in limb movements and behaviour. - Statistics:
- not performed
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off: 500 mg/kg
- Mortality:
- 300 mg/kg bw: No mortality occurred during the test period.
2000 mg/kg bw: 3/3 females died: one female died on the day of exposure, the remaining two females died one day after exposure. - Clinical signs:
- lethargy (hypoactivity)
- observations of tremors
- other:
- Body weight:
- other body weight observations
- Remarks:
- Surviving animals gained weighed throughout the study.
- Gross pathology:
- 300 mg/kg bw: No abnormalities were seen in gross necropsy of any of the animals.
2000 mg/kg bw: One animal exhibited abdominal distention. One animal had brown pigment changes in the lungs and the gastric contents were light yellow. In the third animal, the gastric contents were also light yellow.
Any other information on results incl. tables
Table 1: Acute oral toxicity
Dose [mg/kg bw] | Mortality | Clinical signs |
| N* | N* |
Females | ||
300 | 0/6 | 0/6 |
2000 | 3/3 | 1/3 |
*Number of animals/ number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in rats a LD50 value of > 300 - 2000 mg/kg bw was determined. The LD50 cut-off was 500 mg/kg bw. The substance thus meets the criteria for Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008.
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