Registration Dossier

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:
Single Dose Oral Toxicity study of 2,3-Dihydroxypropyl 9-cis-octadecenoate in rats
Author:
J-CHECK
Year:
2010
Bibliographic source:
Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation, J-CHECK , 2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity study of 2,3-Dihydroxypropyl 9-cis-octadecenoate in rat
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 2,3-Dihydroxypropyl 9-cis-octadecenoate; Glyceryl monooleate
- Molecular formula : C21H40O4
- Molecular weight: 356.54 g/mole
- Substance type: Organic
- Physical State: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,3-Dihydroxypropyl 9-cis-octadecenoate
- Molecular formula (if other than submission substance): C21H40O4
- Molecular weight (if other than submission substance): 356.54 g/mole
- Substance type: Organic

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
IGS
Sex:
female
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: Corn oil
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): Dose were prepared in Corn oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: No data available
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology were examined.
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated female rat at 2000 mg/kg bw
Clinical signs:
No abnormalities in general condition of treated female rats were observed.
Body weight:
No change in body weight of treated female rats was observed.
Gross pathology:
No gross pathological abnormalities were observed in treated female rats.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be >2000 mg/kg bw when Crj:CD(SD)IGS female rat were treated with 2,3-Dihydroxypropyl 9-cis-octadecenoate orally by gavage.
Executive summary:

In a acute oral toxicity study,Crj:CD(SD)IGS female rat were treated with 2,3-Dihydroxypropyl 9-cis-octadecenoate in the concentration of 2000 mg/kg bw orally by gavage. No mortality was observed in treated female rat at 2000 mg/kg bw. No abnormalities in general condition, change in body weight and gross pathological abnormalities were observed in treated female rats. Therefore,LD50 was considered to be >2000 mg/kg bw when Crj:CD(SD)IGS female rat were treated with 2,3-Dihydroxypropyl 9-cis-octadecenoate orally by gavage.