Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Data on toxicokinetics of the submission substance are not available. Default values based on physico-chemical information according to REACH Guidance are therefore used for the estimation of the kinetic profile. Based on the molecular mass of approximately 300 and a log Kow of 2.8 a default value of 100% is used for oral as well as for dermal absorption. Respiratory absorption, however, is considered to be negligible because the material is a solid wax with a very low vapour pressure and a moderate water solubility. 

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100

Additional information

The toxicokinetic profile of a substance comprises its absorption into the body, its distribution in the body, its metabolism in the body and its excretion from the body. Experimental data on toxicokinetics for the registration substance is not available. However, taking into account the physicochemical properties of the registration substance, qualitative estimates for these aspects may be deduced for the submission substance.

A prerequisite for a relevant absorption is that the substance can be dissolved in either aqueous (e.g., gastrointestinal fluid, blood plasma, sweat) or lipophilic (e.g., lipoproteins, lipid membranes, triglycerides) media or in both. The submission substance is moderatly soluble in water and good soluble in n-octanol, leading to a log Kow of 2.8. This relative solubility is favourable for absorption via the gastrointestinal tract following oral exposure as well as regarding dermal absorption. In the absence of substance specific data and according to ECHA Guidance R.7c, a default value of 100% for oral and skin absorption therefore apply for risk characterization purposes. Due to this physico-chemical profile, metabolism and excretion of the submission substance can be expected and thus a bioaccumulation potential can most probably be excluded. The likelihood for inhalation exposure is low due to the very low vapour pressure of the test item. Additionally, since the submission substance is a solid wax, formation of inhalable/respirable aerosols and thus absorption via the inhalation route is unlikely.