Registration Dossier
Registration Dossier
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EC number: 238-339-3 | CAS number: 14367-46-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- U.S. National Library of Medicine
- Year:
- 2 017
- Bibliographic source:
- Chemidplus Database,U.S. National Library of Medicine,2017
- Reference Type:
- publication
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- Aeberli et. al.
- Year:
- 1 975
- Bibliographic source:
- Journal of Medicinal Chemistry
- Reference Type:
- secondary source
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- RTECS
- Year:
- 2 018
- Bibliographic source:
- RTECS (registry of toxic effect of chemical substance database ), 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of test chemical was performed in rats.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- no
Test material
- Reference substance name:
- Fenfluramine
- EC Number:
- 207-276-3
- EC Name:
- Fenfluramine
- Cas Number:
- 458-24-2
- Molecular formula:
- C12H16F3N
- IUPAC Name:
- ethyl({1-[3-(trifluoromethyl)phenyl]propan-2-yl})amine
- Details on test material:
- - Name of test material (IUPAC name): ethyl({1-[3-(trifluoromethyl)phenyl]propan-2-yl})amine
- Common name: Fenfluramine
- Molecular formula: C12H16F3N
- Molecular weight: 231.2594 g/mol
- Smiles notation: CCNC(C)Cc1cccc(c1)C(F)(F)F
- InChl: 1S/C12H16F3N/c1-3-16-9(2)7-10-5-4-6-11(8-10)12(13,14)15/h4-6,8-9,16H,3,7H2,1-2H3
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Royal Hart Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Weight at study initiation:136-160 g
- Housing:animals were placed in 7 x 7 x 14 in wire cages.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 130 mg/kg bw
- No. of animals per sex per dose:
- Total:20 animals
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- The LD50 values were obtained 72 hr post -administration of test chemical using 20 rats and estimated by Probit analysis.
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 130 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 50% mortality was observed at dose 130 mg/kg bw in treated rats
- Clinical signs:
- No data available
- Body weight:
- No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The lethal concentration (LD50) value for acute oral toxicity test was considered to be 130 mg/kg bw,when male Royal Hart Wistar rats were treated with test chemical orally.
- Executive summary:
Acute oral toxicity study was performed in male Royal Hart Wistar rats using test chemical.50% mortality was observed at dose 130 mg/kg bw. Hence,LD50 value was considered to be 130 mg/kg bw,when rats were treated with test chemical orally.
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