reaction mass of (9Z,11E)-octadeca-9,11-dienoic acid and (10E,12Z)-octadeca-10,12-dienoic acid and octadec-9-enoic acid

Acute Toxicity: oral

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