Registration Dossier
Registration Dossier
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EC number: 288-293-3 | CAS number: 85711-34-8
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: expert statement
- Executive summary:
No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400103), but data currently available on physical-chemical properties and from in vivo toxicology studies were evaluated.
The substance, WS400103, is a UVCB substance composed of tall oil fatty acids condensed with diethylenetriamine and phosphoric acid. The major part (> 90%) consists of di-amides with smaller amounts of mono-amides (< 2%) and tri-amides (< 6%). The neat substance (as used in the laboratory tests) is a brown solid. However, the substance is manufactured in organic solvents and then directly diluted in organic solvents to the formulations to be marketed.
Molecular weights of the di-amides amount to approx. 616 Da, those of mono-amides to approx. 353 Da and 879 Da for tri-amides.
The substance has very low water solubility (< 1 mg/L). The octanol water partition coefficient (Log10Pow) was determined to range between values of 2.8 and 4.4.
Based on its physical-chemical properties absorption after oral exposure should be possible to a certain extent. However, in the sub-acute repeated oral dose toxicity study no effects were observed in rats up to and including the highest dose of 1000 mg/kg body weight/day. No conclusion can be drawn if the substance was absorbed and systemically distributed or not.
Systemic availability of WS400103 after dermal application is expected to be low based on the very low water solubility and relatively high molecular weights. However, in the skin sensitisation test in mice (LLNA) skin irritation (of the ear) and a skin sensitisation potential were observed. From these observations it is concluded that at least small amounts of the UVCB substance can penetrate the skin.
Availability of WS400103 under a vapour state will be very limited, because of its low vapour pressure (85 Pa at 20°C).
There is no information on metabolism or excretion of WS400103.
Based on the octanol water partition coefficient bioaccumulation of WS400103 in aquatic organisms is not likely. The bioaccumulation potential in mammals is expected to be low based on the currently available information.
Reference
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400103), but data currently available on physical-chemical properties and from in vivo toxicology studies were evaluated.
The substance, WS400103, is a UVCB substance composed of tall oil fatty acids condensed with diethylenetriamine and phosphoric acid. The major part (> 90%) consists of di-amides with smaller amounts of mono-amides (< 2%) and tri-amides (< 6%). The neat substance (as used in the laboratory tests) is a brown solid. However, the substance is manufactured in organic solvents and then directly diluted in organic solvents to the formulations to be marketed.
Molecular weights of the di-amides amount to approx. 616 Da, those of mono-amides to approx. 353 Da and 879 Da for tri-amides.
The substance has very low water solubility (< 1 mg/L). The octanol water partition coefficient (Log10Pow) was determined to range between values of 2.8 and 4.4.
Based on its physical-chemical properties absorption after oral exposure should be possible to a certain extent. However, in the sub-acute repeated oral dose toxicity study no effects were observed in rats up to and including the highest dose of 1000 mg/kg body weight/day. No conclusion can be drawn if the substance was absorbed and systemically distributed or not.
Systemic availability of WS400103 after dermal application is expected to be low based on the very low water solubility and relatively high molecular weights. However, in the skin sensitisation test in mice (LLNA) skin irritation (of the ear) and a skin sensitisation potential were observed. From these observations it is concluded that at least small amounts of the UVCB substance can penetrate the skin.
Availability of WS400103 under a vapour state will be very limited, because of its low vapour pressure (85 Pa at 20°C).
There is no information on metabolism or excretion of WS400103.
Based on the octanol water partition coefficient bioaccumulation of WS400103 in aquatic organisms is not likely. The bioaccumulation potential in mammals is expected to be low based on the currently available information.
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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