Registration Dossier
Registration Dossier
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EC number: 246-002-7 | CAS number: 24057-28-1
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- evaluation of available information
- Type of information:
- other: expert report
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented expert statement based on a series of physicochemical and toxicology studies with WS400304.
Data source
Reference
- Reference Type:
- other: expert statement
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test material
- Test material form:
- solid
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400304), but data currently available on physical-chemical properties and from in vivo and in vitro toxicology studies were evaluated.
The substance, WS400304, is a salt of p-toluene sulfonic acid and pyridine with molecular weights of 172 and 79 Da, respectively. The substance is well water soluble (> 700 g/L) and accordingly has low lipophilicity (Log10Pow< 1).
After oral administration WS400304 is absorbed and systemically distributed as can be deduced from the adverse effects on livers of male and female rats observed in the sub-acute repeated oral dose toxicity study.
Systemic availability of WS400304 after dermal application is expected to be low based on its hydrophilicity. In the skin irritation test no effects on rabbit skin were observed.
Availability of WS400304 under a vapour state will be very limited, because of its low vapour pressure (40 Pa at 20°C) and because it is a solid hygroscopic substance limiting its availability as an inhalable aerosol.
There is no information on metabolism of WS400304.
Based on the increased kidney weights of male rats observed in the sub-acute repeated oral dose toxicity study renal excretion of WS400304 is rather likely.
Bioaccumulation of WS400304 is very unlikely based on the high hydrophilicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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