Registration Dossier

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics, other
Type of information:
other: expert statement
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well documented expert statement based on a series of physicochemical and toxicology studies with WS400402.
Objective of study:
absorption
Principles of method if other than guideline:
Expert statement based on a series of physicochemical and toxicology studies with WS400402.
Executive summary:

No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400402), but data are currently available fromin vivoandin vitrotoxicology studies.

The test material, WS400402, is a complex mixture of components; their molecular weights range from 173 to 426 Da. The substance is well water soluble (456 g/L) and accordingly has low lipophilicity (Log10Pow< 1).

After oral administration WS400402 or components of this complex mixture are rapidly absorbed and systemically distributed leading to death after a single oral dose of 2000 mg/kg body weight in rats.

Systemic availability of WS400402 after dermal application is expected to be low based on its hydrophilicity. However, in view of the sensitization response attained in a Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations of WS400402 some dermal absorption must have occurred. This may have been only a small fraction of the administered test material.

Availability of WS400402 under a vapour state is unlikely, because of its low vapour pressure (3 x 10-4Pa at 25°C) and because it is a highly viscous liquid limiting its availability as an inhalable aerosol.

WS400402 or components of this complex mixture are rapidly absorbed and systemically distributed as was observed from effects in acute and repeated dose oral toxicity studies. There is no information on metabolism of WS400402.

There is no indication in the available study results regarding the excretion of WS400402 or components thereof.

 

Bioaccumulation of WS400402 is very unlikely based on the high hydrophilicity.

Description of key information

No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400402), but data are currently available fromin vivoandin vitrotoxicology studies.

The test material, WS400402, is a complex mixture of components; their molecular weights range from 173 to 426 Da. The substance is well water soluble (456 g/L) and accordingly has low lipophilicity (Log10Pow< 1).

After oral administration WS400402 or components of this complex mixture are rapidly absorbed and systemically distributed leading to death after a single oral dose of 2000 mg/kg body weight in rats.

Systemic availability of WS400402 after dermal application is expected to be low based on its hydrophilicity. However, in view of the sensitization response attained in a Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations of WS400402 some dermal absorption must have occurred. This may have been only a small fraction of the administered test material.

Availability of WS400402 under a vapour state is unlikely, because of its low vapour pressure (3 x 10-4Pa at 25°C) and because it is a highly viscous liquid limiting its availability as an inhalable aerosol.

WS400402 or components of this complex mixture are rapidly absorbed and systemically distributed as was observed from effects in acute and repeated dose oral toxicity studies. There is no information on metabolism of WS400402.

There is no indication in the available study results regarding the excretion of WS400402 or components thereof.

 

Bioaccumulation of WS400402 is very unlikely based on the high hydrophilicity.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information