Registration Dossier

Physical & Chemical properties

Endpoint summary

Administrative data

Description of key information

The substance is a brown, viscous liquid.

Pour point: 200 ± 3 K

Boiling > 673 ± 0.5 K at 102.31 kPa

Density: 0.979 g/mL at 20.0 ± 0.5 °C

Particle size distribution (Granulometry): Not conducted as non-solid/granular form

Vapour pressure: 4.8 x 10-10Pa at 25 °C

Partition Coefficient > 6.5

Water solubility = 6.8 x 10-3mg/L solution at 20.0 ± 0.5 °C

Solubility in organic solvents: 1155 g/kg ± 34.5

Surface tension: not conducted as the water solubility was below 1 mg/L at 20 °C

Flash point: 211 ± 2 °C

Auto flammability: no auto-ignition temperature below 400 °C

Flammability: Waived based on chemical structure and flash point being more than 200 °C

Explosiveness: non explosive

Oxidising properties: obsolete

Dissociation constant: No observable dissociation

Additional information

JUSTIFICATION FOR USE OF READ-ACROSS DATA

There exists a previously notified ELINCS material with the name:

2,5-Pyrrolidinedione, 1, 1'-(iminodi-2,1-ethanediyl)bis[3-(octadecenyl)-. EC number 425-620-2

This material is considered to be a suitable analogue material for the Registration material by virtue of the similarity of chemistry and this is backed up by the similarity of physicochemical properties, and is further supported by similar toxicological and ecotoxicological data profiles. Both substances are alkenyl succinimide compounds, and the tested/Registration material differs from the analogue only by the alkylation of the secondary nitrogen.The difference between these two materials is that the tested material is alkylated with acetic anhydride, hence making the secondary amine less reactive. The alkyl chain length remains unchanged in comparison of these two materials. This ELINCS material has a complete EU base set for its previous registration and has been evaluated by the Competant Authority at that time and accepted. This registration material has been notified in Japan and is undergoing other global registration, and all of the information available supports the view that both of these materials have a very similar profile in properties. In addition to the almost complete structural similarities, similar physicochemical properties further support the justification for read across from this analogue to this Registration material e.g. similar physical states (brown, viscous liquids), similar density and having the same order of magnitude of partition coefficients. The chemistry is so similar that the reactivity and metabolism pathways are considered to be identical in biological systems, and so the toxicity profile is also very similar where testing information exist. Due to the alkylation, or capping, it is believed that the Registration substance will differ from the analogues material only in potentially demonstrating lower toxicity in comparison with the data for the surrogate/analogue substance. Therefore these data represent worst case hazard potential for the Registration material, and are considered to be an acceptable data set for the Registration material.

Read-across data are applied across many endpoints for this registration material as all the evidence supports the similarity of the profiles and thus it is considered that suitable data values can be predicted from the analogue material, saving animal testing and making maximum use of existing information.