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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics, other
Type of information:
other: expert statement
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No studies are available on adsorption, distribution, metabolism and excretion of WS400152. Predictions were made based on physical-chemical properties and results of toxicological studies.
Executive summary:

The substance WS400152 is a complex mixture of components composed of fatty acids, C18-unsatd., trimers, reaction products with triethylenetetramine. Below some physical-chemical properties are listed:

- Molecular weight: approx. 700 – 1000 Da

- Water solubility: ca 1 mg/l

- Boiling point: decomposes before boiling, decomposition starts at ca. 160°C

- Log Pow: > 5.5

- Vapour pressure : 4 x 10E-3 Pa at 25°C

 

The available physical-chemical and toxicological information on the substance has been evaluated and used to assess the toxicokinetic behaviour.

 

In the ECHA document “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance, 2017” guidance is provided which physical-chemical properties commonly determine dermal, oral and respiratory absorption of substances.

 

Dermal absorption

 

The test material, WS400152, is a complex mixture of components. The low water solubility (ca. 1 mg/L at 20°C), the high lipophilicity (Log10Pow> 5.5 at 25°C) and the high molecular weight (ca. 700 – 1000 Da) are expected to limit its rate of transfer between the stratum corneum and the lower epidermis and dermis after topical administration. Consequently the above physical-chemical properties of WS400152 are considered to limit its systemic availability after topical administration.

However, in view of the sensitization response attained in the Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations of WS400152 some dermal absorption must have occurred. This may have been only a small fraction of the administered test material.

 

Oral absorption

 

The test material, WS400152, is a complex mixture of components. The low water solubility (ca. 1 mg/L at 20°C), the high lipophilicity (Log10Pow> 5.5 at 25°C) and the high molecular weight (ca. 700 – 1000 Da) are expected to limit its absorption after oral administration. Consequently the above physical-chemical properties of WS400152 are considered to limit its systemic availability after oral administration.

Absorption of WS400152, or at least a small fraction thereof, after oral gavage administration is concluded from increased incidence and severity of myocardial inflammation/degeneration/fibrosis and changes in some blood plasma parameters at 1000 mg/kg/day in the repeat dose toxicity study. Adverse effects on bodyweight gain transiently were observed in male animals in this study at 1000 mg/kg/day.

 

Respiratory absorption

 

No data is available on absorption after inhalation. However, inhalation of any vapour from WS400152 is an unlikely route of human exposure, because the substance has a very low vapour pressure (4 x 10-3Pa at 25°C) and decomposes without boiling at high temperatures (≥ ca. 160°C). Exposure of humans to an inhalable aerosol of WS400152 is also unlikely, because it is a highly viscous liquid limiting its availability as an inhalable aerosol.

 

Distribution and metabolism

 

There is no indication in the available study results regarding the distribution or metabolism of WS400152 or components thereof.

 

Excretion

 

There is no information available on excretion of WS400152 in the available studies.

 

Bioaccumulation potential

 

Based on all available information no final conclusion on a bioaccumulation potential can be drawn.

Description of key information

Key value for chemical safety assessment

Additional information

The substance WS400152 is a complex mixture of components composed of fatty acids, C18-unsatd., trimers, reaction products with triethylenetetramine. Below some physical-chemical properties are listed:

- Molecular weight: approx. 700 – 1000 Da

- Water solubility: ca 1 mg/l

- Boiling point: decomposes before boiling, decomposition starts at ca. 160°C

- Log Pow: > 5.5

- Vapour pressure : 4 x 10E-3 Pa at 25°C

 

The available physical-chemical and toxicological information on the substance has been evaluated and used to assess the toxicokinetic behaviour.

 

In the ECHA document “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance, 2017” guidance is provided which physical-chemical properties commonly determine dermal, oral and respiratory absorption of substances.

 

Dermal absorption

 

The test material, WS400152, is a complex mixture of components. The low water solubility (ca. 1 mg/L at 20°C), the high lipophilicity (Log10Pow> 5.5 at 25°C) and the high molecular weight (ca. 700 – 1000 Da) are expected to limit its rate of transfer between the stratum corneum and the lower epidermis and dermis after topical administration. Consequently the above physical-chemical properties of WS400152 are considered to limit its systemic availability after topical administration.

However, in view of the sensitization response attained in the Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations of WS400152 some dermal absorption must have occurred. This may have been only a small fraction of the administered test material.

 

Oral absorption

 

The test material, WS400152, is a complex mixture of components. The low water solubility (ca. 1 mg/L at 20°C), the high lipophilicity (Log10Pow> 5.5 at 25°C) and the high molecular weight (ca. 700 – 1000 Da) are expected to limit its absorption after oral administration. Consequently the above physical-chemical properties of WS400152 are considered to limit its systemic availability after oral administration.

Absorption of WS400152, or at least a small fraction thereof, after oral gavage administration is concluded from increased incidence and severity of myocardial inflammation/degeneration/fibrosis and changes in some blood plasma parameters at 1000 mg/kg/day in the repeat dose toxicity study. Adverse effects on bodyweight gain transiently were observed in male animals in this study at 1000 mg/kg/day.

 

Respiratory absorption

 

No data is available on absorption after inhalation. However, inhalation of any vapour from WS400152 is an unlikely route of human exposure, because the substance has a very low vapour pressure (4 x 10-3Pa at 25°C) and decomposes without boiling at high temperatures (≥ ca. 160°C). Exposure of humans to an inhalable aerosol of WS400152 is also unlikely, because it is a highly viscous liquid limiting its availability as an inhalable aerosol.

 

Distribution and metabolism

 

There is no indication in the available study results regarding the distribution or metabolism of WS400152 or components thereof.

 

Excretion

 

There is no information available on excretion of WS400152 in the available studies.

 

Bioaccumulation potential

 

Based on all available information no final conclusion on a bioaccumulation potential can be drawn.