Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

basic toxicokinetics
Type of information:
other: expert statement
Adequacy of study:
supporting study
Rationale for reliability incl. deficiencies:
other: No studies are available on toxicokinetics, metabolism and distribution of WS400505. Predictions were made based on physical-chemical properties and information from toxicological studies performed with the read-across source substance.

Data source

Reference Type:
other: expert statement

Materials and methods

Test material

Results and discussion

Applicant's summary and conclusion

Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Executive summary:

No specific study was performed on absorption, distribution, metabolism and/or excretion (ADME) of WS400505. Predictions on the toxicokinetic behaviour were made based on physical-chemical properties and information from toxicological studies.

WS400505 is a mono-constituent substance with a purity of > 99% (w/w). The substance is a saturated C41compound with the molecular formula C41H84N4O2. The substance contains two urea bonds the rest being two saturated C18n-alkyl chains and a propyl chain between the two urea groups. The following data on physical chemical properties of WS400505 are the basis for this toxicokinetics assessment.

- Molecular weight: 665 Da
- Water solubility: < 1 mg/l (determined); 3 x 10-12mg/l (calculated by US EPA WSKOWWIN)
- Melting point: 137°-168°C; substance decomposes before boiling
- Octanol/water partition coefficient: log Pow> 6 (determined); log Pow= 16 (calculated by US EPA KOWWIN)
- Vapour pressure: 2 x 10-4Pa (determined)

In all toxicological tests performed with WS400505 according to Annexes VII and VIII of the REACH Regulation no adverse effects were observed up to the highest doses required to be tested according to the relevant guidelines.

The ECHA “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance, 2014” document provides guidance, which physico-chemical properties commonly determine dermal, oral, and inhalatory absorption of substances.

Bioavailability of WS400505 in general is expected to be very limited, because of the relatively high molecular weight, very low water solubility and high lipohilicity of the substance.

Accordingly, systemic availability of WS400505 after topical administration is expected to be very limited.

Also systemic availability of WS400505 after oral administration is expected to be very limited. In toxicity studies with single or repeated oral exposure no adverse effects were observed.

Availability of WS400505 under a vapour state is unlikely, because of its low vapour pressure.

Based on the available data on WS400505 the bioacumulation potential cannot be judged. However, based on the physical-chemical properties systemic availability of WS400505 via dermal, oral and inhalation exposure is expected to be very low. Also the bioaccumulation potential is expected to be very low based on the relatively high molecular weight and the very high octanol/water partition coefficient of the substance. 



While toxicokinetic data is not available on WS400505, based on the properties of the substance and based on the favourable toxicological testing results WS400505 is expected to be hardly bioavailable. Bioaccumulation is not expected. Further information on distribution, metabolism or excretion is not available.