Registration Dossier
Registration Dossier
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EC number: 619-905-2 | CAS number: 915416-45-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): 3',4',5'-Trifluoro-biphenyl-2-ylamine
- Physical state: solid, beige
- Analytical purity: 99.67%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TECAM Animal Facility (S. Roque, SP).
- Age at study initiation: 9 weeks
- Weight range at study initiation: not greater than 20 percent of the mean weight
- Housing: Animals were housed using conventional polypropilene rodent cages (Beiramar, CXBHG, 4 1 X 34 X 16cm) with three animals per cage.
- Diet (e.g. ad libitum): Pelleted commercial diet for the species (Biobase Biotec) was provided ad libitum
- Water (e.g. ad libitum): Filtered water was provided ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 64 (average)
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
Test substance was applied diluted in corn oil (dilution concentration was 500 mg/mL). - Doses:
- 2000 mg/kg bw/day
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed individually after dosing during the first 24 hours with special attention given during the first 4 hours (day 1). Daily thereafter.
- Frequency of weighing: before substance administration. weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- no signs of evident toxicity
- Body weight:
- body weight changes within the range of physiological variability.
- Gross pathology:
- No macroscopic changes were observed in any of the major organs of the examined animals.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
