Registration Dossier

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
Reference
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
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.