Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

A literature-based toxicokinetic assessment was carried out. 

Key value for chemical safety assessment

Additional information

The data presented in this dossier only allows a qualitative assessment of the toxicokinetic behaviour of the substance for registration. The data was awarded a reliability score of 4 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997). However, a couple of significant conclusions can be made.

 

Hyperform™ HPN-20E has a molecular weight of 210 g/mol. It is a poorly soluble solid (solubility 296 mg/L), with over 87 % of the particles being >100 µm in size. The melting point is > 360 °C and the substance has a very low vapour pressure. The logPow is -2.56. The substance appears stable in solution at pH 4, 7 and 9. The substance is essentially non-toxic.

Absorption

The substance is poorly soluble in water and even less soluble in lipids. Thus it is unlikely to be absorbed orally or dermally. Although a poorly soluble particulate, the particle size is such that very little is likely to be inhaled and retained.

Distribution

The substance is essentially unlikely to be distributed and, if administered parenterally, is likely to remain at the site of administration.

Metabolism

Given the solubility profile of the material it is unlikely to become available for metabolism.

Excretion

Given the solubility profile of the substance, it is not likely to be available for excretion. If particles lodge in the alveolus following inhalation, they will be dealt with largely as insoluble particulates, and if the substance is administered orally it is likely to appear in faeces unabsorbed.

 

Conclusion

Given the solubility profile and particle size, the substance is unlikely to be absorbed orally or dermally, and is unlikely to be inhaled and retained. Given the solubility of the material, it is also unlikely to become available for metabolism or excretion. If particles lodge in the alveolus following inhalation, they will be dealt with largely as insoluble particulates, and if the substance is administered orally it is likely to appear in faeces unabsorbed.