Registration Dossier
Registration Dossier
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EC number: 271-692-1 | CAS number: 68604-41-1 The complex residuum from the distillation of the methyl ester of C16-18 and C18-unsatd. fatty acids. It consists primarily of trialkyl glycerides and undistilled methyl ester of the fatty acids.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Remarks:
- read-across from supporting substance (analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From February 2, 1988 to February 29, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well described study conducted to recognized international test guidelines. No data about testing material. See Read Across Justification in the CSR point 1.0
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- IUPAC Name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
Constituent 1
- Specific details on test material used for the study:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- single dose of 10 ml/kg corresponding to 2000 mg/Kg bw per substance
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Non toxic
- Executive summary:
The acute oral toxicity of Edenor ME Ruckstand II was tested in young Wistar rats, breeder Winkelmann Borchen. The test compound was administered by single gavage in arachids oil as solvent and an application volume of 10 ml/Kg body weight to fasted animals. Five rats were used per sex.
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