Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Remarks:
- OECD 423
- Adequacy of study:
- key study
- Study period:
- 22 january 2003 to 29 january 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- as the tested substance is not the registered substance.
- Justification for type of information:
- As an ingredient for a medical device, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
- Molecular formula:
- Not relevant for a UVCB substance
- IUPAC Name:
- Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
- Test material form:
- liquid
- Details on test material:
- The mixture contains 94.4 % of corn oil oxidised (glycerides, C10-20 and C10-20 unsat, oxidised).
Constituent 1
- Specific details on test material used for the study:
- mixture containing 94.4% of oxidised corn oil
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- used after a 5 to 7 day acclimatisation period. temperature : between 19°C and 22°C , relative hulidity : between 36% and 49%
Administration / exposure
- Route of administration:
- other: forced feeding
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- force-feeding
- Doses:
- 5.434 mL/kg body weight
- No. of animals per sex per dose:
- group 1 (control) : 3 male rats and 3 female rats
group 2 (treated) : 3 male rats and 3 female rats - Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study.
- Clinical signs:
- other:
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- no acute oral toxicity
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