Registration Dossier
Registration Dossier
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EC number: 943-389-0 | CAS number: -
Basic toxicokinetics
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 substance name:
- Set Retard Plus - Na salt
- IUPAC Name:
- Set Retard Plus - Na salt
Constituent 1
Test animals
- Details on test animals or test system 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).
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