Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is marketed or used in a non solid or granular form
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Regulation (EC) No. 1907/2006, Annex VII, 7.14, column 2, the study does not need to be conducted, because the substance is not marketed or used in a solid or granular form.
As presented under IUCLID Section 4.1, the present substance is described in its normal state as a paste / block at ambient temperature (manufactured as molten and marketed as cast substance), or can also exist as supercooled liquid. Therefore the present endpoint is not relevant.
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference

The substance can exist either as a solid or a supercooled liquid at ambient temperature.

Physical state at 20°C and 1013 hPa:
liquid

As experimental test reports provided inconsistent descriptions, mainly as solid, but also paste/gel or liquid, a specific investigation was conducted on freezing from the melted substance. This reliable experiment demonstrated the ability of the substance to remain liquid if no initiation for phase change, but turned solid at ca 37-38°C with initiation. Therefore, the normal state in ambient conditions will be considered to be solid. However, as the product will always be used liquid (melted) the liquid state is retained as key data for purpose of CSA.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion