Registration Dossier

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics in vivo
Type of information:
other: expert statement
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An extensive assessment of the toxicokinetic behaviour of the registered substance was performed, taking into account the chemical structure, the available physico-chemical and toxicological data.
Objective of study:
absorption
distribution
excretion
metabolism
toxicokinetics
Qualifier:
no guideline followed
Principles of method if other than guideline:
An extensive assessment of the toxicokinetic behaviour of the registered substance was performed, taking into account the chemical structure, the available physico-chemical and toxicological data.
GLP compliance:
no
Route of administration:
other: all relevant routes of administration are discussed in the expert statement
Type:
absorption
Results:
The absorption rate of the substance is assumed to be 100 % via the oral, dermal and inhalation route
Type:
distribution
Results:
The substance is not expected to be distributed widely throughout the body.
Type:
metabolism
Results:
Transport between cells through cell membranes might be possible.
Type:
excretion
Results:
The substance is expected to be mainly excreted via the bile since it is amphipathic (containing both polar and nonpolar regions) and has a high molecular weight.
Executive summary:

The absorption rate of the substance is assumed to be 100 % via the oral, dermal and inhalation route. The substance is not expected to be distributed widely throughout the body. Transport between cells through cell membranes might be possible. The substance is expected to be mainly excreted via the bile since it is amphipathic (containing both polar and nonpolar regions) and has a high molecular weight. For more details please refer to attached expert statement in section 13.

Description of key information

The absorption rate of the substance is assumed to be 100 % via the oral, dermal and inhalation route. The substance is not expected to be distributed widely throughout the body. Transport between cells through cell membranes might be possible. The substance is expected to be mainly excreted via the bile since it is amphipathic (containing both polar and nonpolar regions) and has a high molecular weight.

Key value for chemical safety assessment

Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100
Absorption rate - inhalation (%):
100

Additional information