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:
March 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 is absorbed on ingestion and metabolised via understood paths for azo dyes such as azo reduction. Such metabolites are subsequently eliminated within urine. Consequently, the substance is considered to have low bioaccumulation potential.
Executive summary:

In conclusion, there is evidence that the substance is absorbed on ingestion and metabolised via understood paths for azo dyes such as azo reduction. Such metabolites are subsequently eliminated within urine. Consequently, the substance is considered to have low bioaccumulation potential.

Description of key information

Experimental toxicokinetics studies are not available. Assessment of the toxicokinetic behavior of the substance was performed following the relevant available information.

The evaluation of toxicokinetics is based on information from following sources:

- Experimental data of toxicological tests

- Literature data

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100
Absorption rate - inhalation (%):
100

Additional information

As a worse case absorption rate has been set to 100% for all routes.