Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Basic toxicokinetics
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:
- 2 012
- Report date:
- 2012
Materials and methods
Test material
Constituent 1
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.
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