Registration Dossier

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics, other
Remarks:
Written assessment
Type of information:
other: Written assessment
Adequacy of study:
other information
Study period:
January 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Written assessment
Justification for type of information:
At the current level of registration, a written assessment is suitable.
Objective of study:
other: Written assessment of ADME
Qualifier:
no guideline required
Principles of method if other than guideline:
Written assessment based on available study data.
Details on absorption:
See attached background material below.
Details on distribution in tissues:
See attached background material below.
Details on excretion:
See attached background material below.
Details on metabolites:
See attached background material below.
Bioaccessibility testing results:
See attached background material below.
Conclusions:
In conclusion, there is evidence that the substance, could be readily absorbed on ingestion and metabolised quickly to amino acids, amines and ultimately oxidised to carbon dioxide and nitrogen compounds, with no ill effects noted.
Consequently, the substance is considered to have low bioaccumulation potential.
Executive summary:

In conclusion, there is evidence that the substance, could be readily absorbed on ingestion and metabolised quickly to amino acids, amines and ultimately oxidised to carbon dioxide and nitrogen compounds, with no ill effects noted.

Consequently, the substance is considered to have low bioaccumulation potential.

Description of key information

Written assesssment of toxicokinetics.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100
Absorption rate - inhalation (%):
100

Additional information

In conclusion, there is evidence that the substance, could be readily absorbed on ingestion and metabolised quickly to amino acids, amines and ultimately oxidised to carbon dioxide and nitrogen compounds, with no ill effects noted.

Consequently, the substance is considered to have low bioaccumulation potential.