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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Identification of fatty acid amides in human plasma.
Author:
Arafat, E.S. et al.
Year:
1989
Bibliographic source:
Life Science, Vol 45: 1679-1687 .

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
other: human fatty acid amide plasma levels
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Identification of fatty acid amides in human plasma.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not applicable, determination of endogenous oleamide levels.

Method

Type of population:
general
Subjects:
- Number of subjects: 16
- Sex: females

Ethical approval:
not specified
Route of exposure:
other: not applicable
Reason of exposure:
other: Not applicable as no exposure was performed. Naturally occurring oleamide was determined in human plasma.
Exposure assessment:
not specified

Results and discussion

Clinical signs:
No clinical signs reported.

Any other information on results incl. tables

Naturally occurring oleamide was reported to be one of five primary fatty acids amine present in human plasma; endogenous levels up to 31.7 µg/mL have been reported. Clearly, the C18:1 amide dominates the plasma fatty acid amides content.

 

However, it should be noted that this value represents a case observation in a single person, representative for 10 of the 16 tested individuals, but without the manifestation of effects; in the other 6 individuals investigated in the same study oleamide plasma levels were much lower or not detectable.

 

 

Applicant's summary and conclusion