Registration Dossier

Physical & Chemical properties

Endpoint summary

Administrative data

Description of key information

Additional information

The registration of the test material employs a combined approach for addressing the required endpoints. When data are not available, data from the read across substances are used to address the required endpoints.

The read across substances are structurally similar to registered substance. The substance and the proposed structural analogues are predominantly C32 – C36 alkyl fatty amides. These substances are expected to be metabolised by fatty acid amide hydrolase and esterases. Any differences among the substance structures are not expected to result in any significant differences in the toxicological effects or degradation products.

The following endpoints include supporting studies to provide evidence of read across suitability:

            Water solubility

            Partition Coefficient

 

Physical state

The test material is a tan colour solid block at room temperature.

Melting / freezing point

In an OECD 102 study, conducted according to GLP, the melting point of the test material is 85.1°C.

Boiling point

In an OECD 103 study, conducted according to GLP, the boiling point of the test material is greater than 400°C.

Relative density

In an OECD 109 study, conducted according to GLP, the relative density of the test material is 0.915 at 20°C.

Granulometry

According to 7.14 Column 2 Annex VII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the granulometry (particle size) of a substance does not need to be conducted if the substance is marketed, or used, in the EU in a non-solid or granular form. Although the test material is a solid at room temperature due to the physical nature of the test material (a waxy solid block), the particle size distribution could not be determined according to European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances (2002); therefore, this endpoint is waived.

Vapour pressure

In an OECD 104 study, conducted according to GLP, the vapour pressure of the test material is less than 0.0042 Pa at 25℃.

Partition coefficient n-octanol/water

Key Study:

In an OECD 107 study, conducted according to GLP, the Partition Coefficient of the test material is log Pow greater than 6.5 at 20℃.

Supporting Studies:

In an EU Method A8 study, not conducted according to GLP, the Partition Coefficient of the structurally similar read across substance is greater than 5.7 at 23.

In an EU Method A8, not conducted according to GLP, the Partition Coefficient of the structurally similar read across substance is log Pow greater than5.7 at 23.

Water solubility

Key Study:

In an OECD 105 study, conducted according to GLP, the water solubility of the test material is less than 0.0506 mg/L, and is therefore considered insoluble in water.

Supporting Studies:

In an EU Method A.6 study, not conducted according to GLP, the water solubility of the structurally similar read across substance is less than 0.01 mg/L.

In an EU Method A.6 study, not conducted according to GLP, the water solubility of the structurally similar read across substance is less than 0.05 mg/L.

Surface tension

The study does not need to be conducted because water solubility is below 1mg/L at 20°C. This study is waived.

Flash point

The study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids. The study is waived.

Autoflammability / self-ignition temperature

In an EU Method A15 study, conducted according to GLP, the auto-ignition temperature of the test material is 384±5.

Flammability

In an EU Method A10 study, conducted according to GLP, the test material is not flammable as it failed to ignite in the preliminary screening test. The result of the preliminary screening test obviated the need to perform the main test.

Explosive properties

In an EU Method A.14 study, conducted according to GLP, the structures of the test material was assessed for chemical groups that imply explosive properties. There are no structural alerts within the chemical structure of the test material. Based on the chemical structures of the test material the result for the explosive properties is predicted negative. 

Oxidising properties

In an EU Method A.21 study, conducted according to GLP, the structures of the test material is assessed for chemical groups that imply oxidising properties. There are no structural alerts within the chemical structure. Based on the chemical structures of the test material the result for the oxidising properties is predicted negative.

Stability in organic solvents and identity of relevant degradation products

The study does not need to be conducted because the stability of the substance is not considered to be critical. This endpoint has been waived.

Dissociation constant

Due to the very low water solubility of the test material (less than 0.0506 mg/L), a physical study could not be completed, therefore an OECD Guideline 112 was not carried out. Computer estimation, conducted within a laboratory, under GLP conditions, gave pKas for the amide nitrogen at 16.4 and -0.48. 

Viscosity

The study does not need to be conducted because the substance is a solid. This endpoint has been waived.