Registration Dossier
Registration Dossier
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EC number: 619-484-5 | CAS number: 895525-72-1
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: GLP study according to EU / OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- {[2-(trifluoromethyl)phenyl]formamido}methyl acetate
- EC Number:
- 619-484-5
- Cas Number:
- 895525-72-1
- Molecular formula:
- C11H10F3NO3
- IUPAC Name:
- {[2-(trifluoromethyl)phenyl]formamido}methyl acetate
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: tap water with the aid of 2% Cremophor EL
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per dose
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals dosed with 2000 mg/kg body weight died during the observation period. No deaths or moribound animals occured in the 300 mg/kg bw group.
- Clinical signs:
- other: 2000 mg/kg bw : decreased motility, uncoordinated gait, labored breathing, piloerection, abdominal position, temporary creeping gait, closed eyelids, bloodcrusted snout, lateral position and bloody eyes. A dose of 300 mg/kg body weight was tolerated by f
- Gross pathology:
- The gross pathology investigations revealed: liver dark-red; stomach hemorrhagic and indurate; kidneys dark-red.
A dose of 300 mg/kg body weight was tolerated by female rats without pathological findings.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to OECD guideline 423 the LD50 cut-off of the test item is 500 mg/kg bw. (Category 4 of the Globally Harmonized Classification System).
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