Registration Dossier
Registration Dossier
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EC number: 800-036-4 | CAS number: 1422423-64-0
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
- IUPAC Name:
- Set Retard Plus
- Test material form:
- solid: particulate/powder
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 principal metabolites/transformation products were identified:Lysine and Sodium hydrogen succinate
Any other information on results incl. tables
Further information in the attachment
Applicant's summary and conclusion
- Conclusions:
- No bioaccumulation potential.
- Executive summary:
The target substance is expected to be biochemically stable and not bioavailable; after oral administration it is expected to be mainly excreted as such, without interaction with the life-system. Nevertheless, because a partial dissociation to free acid is possible when the chelate is in the stomach at low pH, the possibility of a partial metabolism/transformation of the substance cannot be excluded, the available information on possible metabolites/transformation products of the target substance, has been precautionary taken into account.
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