Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2013

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Oral administration of the test item to healthy human volunteers
- Parameters analysed / observed: Quantification of total lipids anf free fatty acids, quantification of CLA and its metabolites
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 27
- Sex: male/female
- Age: > 30, < 40 years
Ethical approval:
confirmed, but no further information available
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
A capsule which contained 1 g of 80 % CLA (63 % c9t11, 13 % t10,c12, 3 % cll,t13), 14 % oleic acid, 3 % linoleic acid and 5 % palmitic acid) was given daily for two months.
Group 1 served as control with no CLA supplement.
• Group 2 was assigned to a dietary intake of 0.8 g/d CLA
• Group 3 was assigned to a dietary intake of 1.6 g/d CLA
• Group 4 was assigned to a dietary intake of 3.2 g/d CLA
Examinations:
- Other:
Quantification of total lipids and free fatty acids and of CLA and its metabolites in blood samples.

Results and discussion

Any other information on results incl. tables

The plasma concentration of c9,t11 CLA increased linearly 3-, 6- and 11-fold, with respect to unsupplemented controls, following dietary supplementation with 0.8, 1.6 or 3.2 g/d of CLA intake, respectively. The metabolites of c9,t11 CLA after delta 6 desaturation (CD 18:3) increased 1.5-, 2- and 4- fold with respect to unsupplemented controls, while CD 20:3 reached a plateau at 4-fold increase after 1.6 g/d CLA intake. The peroxisomal beta oxidation product, CD 16:2, increased of 1.5-, 2- and -3 fold in plasma. The ratio be tween the plasma value of CD 16:2 and CLA which indicates the peroxisomal beta oxidation ratio, decreased linearly up to 1.6 g/d CLA intake, and stabilised at this level of CLA intake. CLA supplementation between 0.8 and 3.2 g/d did not cause any significant changes in plasma cholesterol levels. After two months wash out period, plasma levels of CLA returned to basal levels, for all levels of dietary CLA supplementation.

Applicant's summary and conclusion