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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
