Registration Dossier
Registration Dossier
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EC number: 946-756-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study in rats (SIDS-report, 2010), an LD50 of above 2000 mg/kg bw was determined.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- The test item consists of approximately 80% of the two CLA isomers c9,t11 : t10,c12 at a ratio of 1:1. The test item is manufactured from safflower oil via trans-esterification with ethanol to form fatty acid ethyl esters, isomerisation (conjugation) under alkaline conditions, hydrolysis of the ethyl esters and separation of the CLA from the reaction mixture by distillation, and lipase-catalysed re-esterification of the CLA with glycerol. The single steps of the process are procedures commonly applied in the isolation, refinement and modification of vegetable fats and oils. For a detailed composition, see table 1.
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Scientific opinion of the EFSA on the test item.
Additional information
In an acute oral toxicity study in rats (strain unspecified) commercial beadlets of the test item (unknown purity) were administered (SIDS-report, 2010). Based on the results of the observed mortality, an LD50 of above 2000 mg/kg bw was determined.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
