Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Scientific Opinion on the safety of “conjugated linoleic acid (CLA)-rich oil” (Tonalin® TG 80) as a Novel Food ingredient
Author:
European Food Safety Authority (EFSA)
Year:
2010
Bibliographic source:
cited in: EFSA Journal 2010; 8(5):1600

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

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.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met