Registration Dossier
Registration Dossier
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EC number: 254-529-9 | CAS number: 39577-43-0
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
Reference
- Reference Type:
- other: Authoritative database
- Title:
- Acute oral toxicity of CAS No.: 19794-93-5
- Author:
- Authoritative database
- Year:
- 2 017
- Bibliographic source:
- ChemIDplusA TOXNET Database, 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Principles of method if other than guideline:
- Acute oral toxicity study of Trazodone in mice
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Trazodone
- Cas Number:
- Trazodone
- Molecular formula:
- C19H22Cl-N5O
- IUPAC Name:
- Trazodone
- Details on test material:
- - Name of test material (as cited in study report): Trazodone
- Molecular formula (if other than submission substance): C19H22ClN5O
- Molecular weight (if other than submission substance): 371.8698 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Trazodone
- Molecular formula (if other than submission substance): C19H22ClN5O
- Molecular weight (if other than submission substance): 371.8698 g/mole
- Substance type: Organic
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 610 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 610 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality observed
- Mortality:
- 50% mortality was observed in treated mice.
- Clinical signs:
- other: Dyspnea of Lungs, Thorax or Respiration was observed. Convulsions or Effect on Seizure Threshold and Somnolence (General Depressed Activity) were observed in treated mice.
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 was considered to be 610 mg/kg bw when mice were treated with Trazodone orally.
- Executive summary:
In a acute oral toxicity study, mice were treated withTrazodone orally. 50% mortality was observed in treated mice. Dyspnea of Lungs, Thorax or Respiration was observed. Convulsions or Effect on Seizure Threshold and Somnolence (General Depressed Activity) were observed in treated mice. Therefore,LD50 was considered to be 610 mg/kg bw when mice were treated withTrazodone orally.
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