Registration Dossier
Registration Dossier
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EC number: 215-549-3 | CAS number: 1330-80-9
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:
- 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:
- 2 010
- 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
- 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 substance name:
- 2,3-dihydroxypropyl oleate
- EC Number:
- 203-827-7
- EC Name:
- 2,3-dihydroxypropyl oleate
- Cas Number:
- 111-03-5
- Molecular formula:
- C21H40O4
- IUPAC Name:
- 2,3-dihydroxypropyl octadec-9-enoate
- 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
Constituent 1
- 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 or test system 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.
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