Registration Dossier
Registration Dossier
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EC number: 206-220-5 | CAS number: 311-28-4
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer- reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Synthesis and Skeletal Muscle Relaxant Activity of Quaternary Ammonium Salts of Dantrolene and Clodanolene
- Author:
- K. O. ELLIS, R. L. WHITE, Jr., G. C. WRIGHT, and F. L. WESSELS
- Year:
- 1 980
- Bibliographic source:
- Journal of Pharmaceutical Sciences Vol. 69. No. 3 (March 1980) pp327-331
Materials and methods
- Principles of method if other than guideline:
- Acute oral toxicity study was conducted by using Tetrabutylammonium iodide in mice.
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Tetrabutylammonium iodide
- EC Number:
- 206-220-5
- EC Name:
- Tetrabutylammonium iodide
- Cas Number:
- 311-28-4
- Molecular formula:
- C16H36N.I
- IUPAC Name:
- tetrabutylammonium iodide
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Tetrabutylammonium iodide
- Molecular formula : C16H36NI
- Molecular weight: 369.367 g/mol
- Substance type:Organic
- Physical state:Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1-Butanaminium, N,N,N-tributyl-, iodide (1:1)
- Molecular formula (if other than submission substance): C16H36N.I
- Molecular weight (if other than submission substance): 369.367 g/mole
- Substance type: Organic
Test animals
- Species:
- mouse
- Strain:
- other: TAC: SWfBr
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Fasting period before study: Unfasted
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Saline
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1600 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: Saline
- Lot/batch no. (if required): No data available
- Purity: No data available
MAXIMUM DOSE VOLUME APPLIED: No data available
DOSAGE PREPARATION (if unusual): N, N, N-tributylbutan-1-aminium bromide was suspended in saline to prevent the gel formation that occurred occasionally in methylcellulose at the higher concentrations. - Doses:
- 1600 mg/kg
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 72 hr
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No
- Other examinations performed: Mortality was observed. - Statistics:
- The LD50 values were calculated using the Litchfield and Wilcoxon method
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male
- Dose descriptor:
- LDLo
- Effect level:
- 1 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Mortality observed
- Mortality:
- 60 % Mortality was observed in treated mice at 1600 mg/kg
- Clinical signs:
- other: 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:
- LDLo (LD60) was considered to be 1600 mg/kg when mice were treated with 1-Butanaminium, N,N,N-tributyl-, iodide (1:1) orally.
- Executive summary:
In acute oral toxicity study, micetreated with 1-Butanaminium, N,N,N-tributyl-, iodide (1:1) in the concentration of 1600mg/kg orally and observed for 72 hours.60 % Mortality was observed in treated mice at 1600 mg/kg. Therefore,LDLo (LD60) was considered to be 1600 mg/kg when mice were treated with 1-Butanaminium, N,N,N-tributyl-, iodide (1:1) orally.
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