Registration Dossier
Registration Dossier
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EC number: 294-589-3 | CAS number: 91744-27-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 Jul 1984 to 14 Aug 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Detailed study summary is provided
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid, 12-hydroxy-, [R-(Z)]-, mono- and diester with glycerol
- EC Number:
- 294-606-4
- EC Name:
- 9-Octadecenoic acid, 12-hydroxy-, [R-(Z)]-, mono- and diester with glycerol
- Cas Number:
- 91744-44-4
- IUPAC Name:
- 9-Octadecenoic acid, 12-hydroxy-, (R-(Z))-, mono- and diester withglycerol
Constituent 1
- Specific details on test material used for the study:
- Name as cited in study report: Loxiol G11
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- TNO
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann GmbH
- Weight at study initiation (mean): male: 174g / female: 141g
- Fasting period before study: yes, duration not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- propylene glycol
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
- Doses:
- A single dose of 5000 mg/kg on an empty stomach
- No. of animals per sex per dose:
- 5 male and 5 female per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0% for male and female
- Clinical signs:
- The first five hours of application the animals had a ruffled fur
- Gross pathology:
- Hydrometra in one animal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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