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EC number: 206-884-6 | CAS number: 393-11-3
- 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:
- Experimental phase: 1.3.2012 - 13.4.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- One protocol deviation which does't have impact on the study. Cage materials were different.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-nitro-3-(trifluoromethyl)aniline
- EC Number:
- 206-884-6
- EC Name:
- 4-nitro-3-(trifluoromethyl)aniline
- Cas Number:
- 393-11-3
- Molecular formula:
- C7H5F3N2O2
- IUPAC Name:
- 4-nitro-3-(trifluoromethyl)aniline
Constituent 1
- Specific details on test material used for the study:
- Name: FAMI-III, 2-Nitro-5-amino bentsotrifluoride
Alternative name: 4-Nitro-3-(trifluoromethyl)aniline
Batch number: 1332571
Expiry date: 31.12.2012
Description: tan-brownish yellow powder
Storage conditions: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone (UD), Italy
- Age range: 6-7 weeks
- Weight range: 159-175 g
- Housing: group, 3/cage
- Water: Ad libitum
- Diet: Ad libitum exept fasting procedure
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 55 ± 15
- Air changes (per hr): 15-20
- Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % aqueous solution
- Details on oral exposure:
- By gavage, using a plastic feeding tube attached to a graded syringe.
- Doses:
- 2000 mg/kg, 200 mg/mL
300 mg/kg, 30 mg/mL
50 mg/kg, 5 mg/mL - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The animals were fasted overnight before dosing up to 4 hours after dosing but had free access to water. The animals were observed on dosing and approximately 0,5; 2 and 4 hours after administration of the test item and daily thereafter. The observation period was 14 days. The animals were weighed individually on day before administration of the test item, on day 1 and thereafter on days 2, 8 and 15. Mortality and morbidity obsevations twice daily. Termination on day 15. Euthanasian method: Carbon dioxide narcosis.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Mortality:
- All animals dosed at 2000 mg/kg died on Day 1-2. Mortality also occurred 3/6 animals dosed at 300 mg/kg on Day 2 to 4. No mortality occurred dosing at 50 mg/kg.
- Clinical signs:
- Dose 2000 mg/kg: reduced activity, ataxia, moribund status and yellow staining in the cage tray were observed.
Dose 300 mg/kg: Clinical signs were piloerection, reduced activity, lethargy, prone posture, yellow staining of the cage tray and moribund status.
Dose 50 mg/kg: Clinical signs were piloerection and yellow stainig in the cage tray. - Body weight:
- Dose 300 mg/kg: Body weight losses or no body weight growth were recorded.
Dose 50 mg/kg: very slight body weight losses (few grams) were recorded. - Gross pathology:
- 2000 mg/kg
Gastrointestinal track: abnormal colous and/or contents in the stomach, jejunum and ileum. Peyer's patches resulted prominent in two animals.
Abdominal cavity: Abnormal red areas in the stomach. Abnormal colour of liver and mesenteric lymph nodes. Abnormal colour of ovaries associated with enlarged size. Abnormal colour of the adrenals.
Cranial cavity: abnormal colour of brain and pituitary.
Thoracic cavity: abnormal colour of thymus associated with abnormal areas and dark red colour of the lungs.
300 mg/kg
Decedent animals: yellow staining of the urogenital region.
50 mg/kg
Abnormal size (enlarged) of ovaries and abnormal areas of thymus.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Oral LD50 > 50 - < 300 mg/kg bw
- Executive summary:
The acute oral toxicity of the test item 2-Nitro-5-amino bentsotrifluoride ( 4-Nitro-3-(trifluoromethyl)aniline) was evaluated in female Sprague Dawley rats according to OECD 423, EC 2008/440/EC B.1 tris, US EPA OPPTS 870.1100 guidelines and in compliance with GLP. The test substance induced mortality in the rat following oral administration of a single dose at levels of 2000 and 300 mg/kg. Main clinical sings after 2000 mg/kg were reduced activity, ataxia and moribund status and after 300 mg/kg reduced activity, lethargy, prone posture and moribund status. Gross pathology examination showed abnormal colour and/or abnormal contents in the parts of Gastrointestinal track, Abdominal cavity, Cranial cavity and Thoracic cavity at dose 2000 mg/kg. At 300 mg/kg dose decedent animals showed yellow stainign of the urogenital region. No mortality or other relevant signs of toxicity were observed following dosing at 50 mg/kg. The results suggest the LD50 to be greater than 50 mg/kg but lower than 300 mg/kg bw and indicate the classification of Acute Oral Toxicity Category 3.
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