Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
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 peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Acute Toxicity to the rat
Author:
SCALA et al.
Year:
1973
Bibliographic source:
American Industrial Hygiene Association Journal

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Acute oral toxicity of the given test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation (if other than submission substance): C(CCCCCCO)CCCCCC
- InChl (if other than submission substance): 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation (if other than submission substance): C(CCCCCCO)CCCCCC
- InChl (if other than submission substance): 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
Fasting period before study: 3-4 hours prior to study
Housing: Group - housed
Diet (e.g. ad libitum):ad libitum
Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Concentration in vehicle: 0.032 to 10.0ml/kgbw
MAXIMUM DOSE VOLUME APPLIED: 10.0 ml/kgbw
CLASS METHOD (if applicable)
Rationale for the selection of the starting dose:
A dosing schedule employing half log
separations and ranging from 0.032 to 10.0 ml/kg body weight was generally used.
The results have been converted to weight
units by means of the specific gravity.
Doses:
0.032 to 10.0 ml/kg bw
No. of animals per sex per dose:
groups of 5 male rats
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days (or other?): 7 to 14 days
Frequency of observations and weighing: Observations for signs of toxicity were made frequently on the day of administration and daily thereafter for a period of 7 to 14 days
Necropsy of survivors performed: yes/no: Yes
Statistics:
The mortality data were analyzed by the moving average of Horn or the method of Litchfield and Wilcoxon. The results have been converted to weight units by means of the specific gravity.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4 750 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% Mortality observed at 4750 mg/kg bw
Mortality:
50% Mortality observed at 4750 mg/kg bw.
Clinical signs:
The principal signs of effect were central nervous system depression and labored respiration. The depression included inactivity, ataxia, limb sprawling, depressed righting and placement reflexes, prostration, and coma.
Body weight:
No data
Gross pathology:
Gross necropsy revealed some evidence of gastrointestinal irritation.
Other findings:
No data

Any other information on results incl. tables

Table: Acute Oral toxicity of Alcohols

Alcohol

Carbon No.

LD50 gm/kg

Tridecyl

13

4.75a

 

a- LD50 value was estimated, since mortality pattern was not suitable for analysis.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be 4750 mg/kg bw, when groups of 5 male Sprague-Dawley rats were treated with the given test chemical via oral gavage route.
Executive summary:

Acute oral toxicity study was conducted by using test chemical in groups of 5 male Sprague-Dawley rats at the concentration ranging from 0.032 to 10.0 ml/kg body weight. The given test chemical was dissolved in a corn oil suspension or in undiluted form. The animals had been fasted for 3 to 4 hours prior to the study and were group-housed, with water and feed freely available after dosing. Observations for signs of toxicity were made frequently on the day of administration and daily thereafter for a period of 7 to 14 days. Gross necropsy examinations were performed on all animals that died or were killed. The mortality data were analyzed by the moving average of Horn or the method of Litchfield and Wilcoxon. The results have been converted to weight units by means of the specific gravity. LD50 was estimated, since mortality pattern was not suitable for analysis. 50% Mortality observed at 4750 mg/kg bw.The principal signs of effect were central nervous system depression and labored respiration. The depression included inactivity, ataxia, limb sprawling, depressed righting and placement reflexes, prostration, and coma.Gross necropsy revealed some evidence of gastrointestinal irritation. Therefore, the acute oral toxicity dose (LD50) was considered to be 4750 mg/kg bw, when groups of 5 male Sprague-Dawley rats were treated with the test chemical via oral gavage route.