Registration Dossier

Physical & Chemical properties

Endpoint summary

Administrative data

Description of key information

Additional information

PC2414 is a white solid (powder) which melts in the range of 59.6 to 108 °C and decomposes from approximately 121 °C. The vapour pressure is 2.4 x 10-3 Pa at 25 ºC and the relative density has been determined to be 1.27 at 27 ± 1.5 °C.

In water, PC2414 hydrolyses fully within 1 hour to the two main hydrolysis products, N-Hydroxysuccinimide (NHS) and “Impurity 4” (PC2414 without NHS). Due to the hydrolytic instability, the water solubility was estimated using computer based methods. Hence, the water solubility of the parent substance (PC2414) was estimated to be 1.94 x 10-2g/l at 25 °C. The water solubility of the two main hydrolysis products, N-Hydroxysuccinimide (NHS) and “Impurity 4”, were estimated to be 1 x 103and 6.4 x 10-4g/l at 25 °C, respectively.

The partition coefficient was determined to be 54.5, log10 Pow 1.74 at pH 2.4 and the surface tension of PC2414 (hydrolysed form) was determined to be 70.1 mN/m at 22.8 ± 0.5 °C.

The particle distribution of PC2414 was characterized by 10.6 % having an inhalable particle size < 100µm, 2.66% having a thoracic particle size < 10.0µm and 0.63 % having a respirable particle size <5.5 µm. An accurate assessment of the mass median aerodynamic diameter could not be determined due to too few particles were of size less than 10.0 um.

 

There are no chemical groups within the structure of PC2414 which imply explosiveness or oxidising properties using the Bretherick’s Handbook of Reactive Chemical Hazards, 4th Edition, Butterworths, London, 1990, hence the results has been predicted negative. Furthermore, PC2414 is not highly flammable and no flammable gas is evolved either in contact with water or humid air.