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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Link to relevant study record(s)

Reference
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
Objective of study:
metabolism
Principles of method if other than guideline:
Expert Judgement
GLP compliance:
no
Details on test animals or test system and environmental conditions:
Toxicokinetic assessment
Preliminary studies:
Toxicokinetic assessment
Metabolites identified:
yes
Details on metabolites:
Two principal metabolites/transformation products were identified:Lysine and Sodium hydrogen succinate

Further information in the attachment

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.

Description of key information

No bioaccumulation potential

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

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.