Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
Assessment
Type of information:
other: Assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert Judgement evaluation. Meets generally scientific principles, acceptable for the assessment

Data source

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
Expert Judgement
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Details on test animals and environmental conditions:
Toxicokinetic assessment

Results and discussion

Preliminary studies:
Toxicokinetic assessment

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Two main metabolites were identified: Lysine and Succinic acid

Any other information on results incl. tables

Further information in the attachment

Applicant's summary and conclusion

Conclusions:
No bioaccumulation potential.
Executive summary:

The substance is expected to undergo significant enzymatic metabolism giving its two main breakdown products, i.e. succinic acid and lysine. Especially when under the acidic conditions of the stomach the half-life value of the substace is expected to be low (litterature research showed that half-lifes of several amide/peptide bonds were in the order of magnitude of minutes). Detailed information is provided in the attached document of the present endpoint and the read across justification document (IUCLID section 13).