Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
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