Registration Dossier

Administrative data

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, environmental and toxicology studies with WS400123 or a formulation of it, in general performed according to technical guidelines and in compliance with GLP in internationally recognized contract research organizations.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Executive summary:

No specific study was performed on the absorption, distribution, metabolism and/or excretion (ADME) of WS400123, a complex mixture of components. Low to moderate absorption and systemic availability of WS400123 or some of its components after oral exposure has been concluded from small, non-adverse changes observed in some blood parameters in the subacute and subchronic toxicity studies in rats. Dermal absorption has been concluded from the sensitization response attained in a Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations of WS400123.

Exposure of humans to WS400123 by the inhalation route is unlikely, because of its very low vapour pressure (1 x 10-3Pa at 25°C), its decomposition at high temperature without boiling (above ca. 150°C) and because it is a highly viscous liquid.

All available study results gave no indication regarding the distribution, metabolic pathway, or excretion of WS400123.

Bioaccumulation was not investigated, but in view of its Log10Pow< +1, WS400123 is not considered to have a bioaccumulation potential.