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Toxicological information

Acute Toxicity: oral

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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:
1980
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

Constituent 1
Chemical structure
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
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.