Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
2017
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

Constituent 1
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
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:
Dyspnea of Lungs, Thorax or Respiration was observed.

Convulsions or Effect on Seizure Threshold and Somnolence (General Depressed Activity) were observed in treated mice.
Body weight:
No data available
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.