Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

Endpoint summary

Additional information

Stability of KEL3587 in the environment:

 

In accordance with Annex X of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), information regarding phototransformation in air, as well as in water and soil, is not mandatory.

 

In Annex VIII column 2 of the REACH Regulation, it is suggested, that a study on the "Hydrolysis as function of pH" does not need to be conducted if the “substance is readily biodegradable". It can be concluded that a study on the hydrolysis as a function of pH is not required based on the rapid biodegradability of KEL3587 in the environment

 

Biodegradation of KEL3587:

 

A reliable (Klimisch 1) biodegradation study has been conducted for KEL3587 and is included in this dossier. The key study, Kronenberger et al (2007), determined that KEL3587 is readily biodegradable based on 77% degradation in 28-days and passing the 10-day window.  Consequently this study will be taken for the biodegradation in water endpoint.

 

Waiver. In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, the soil simulation test and the sediment simulation test (required in Sections 9.2.1.2, 9.2.1.3 and 9.2.1.4 respectively) do not need to be conducted as direct or indirect exposure of surface water, soil and sediment is unlikely as substance is readily biodegradable.The chemical safety assessment does not indicate any need to investigate further the degradation of the substance and its degradation products. Also, the substance’s very low log octanol-water partition coefficient (Log Kow) of<=- 0.46 at a neutral pH indicating low adsorptive potential. Therefore, no additional degradation testing is necessary based on unlikely exposure. Identification of degradation products (required in Section 9.2.3) is also not necessary. 

 

Bioaccumulation of KEL3587:

 

Reliable measured bioconcentration information is not available for KEL 3587, and a waiver is justified. 

In accordance with Column 2 of REACH Annex IX, the bioaccumulation test on fish need not be conducted if the substance has a low potential for bioaccumulation (for instance a log Kow <3) and/or a low potential to cross biological membranes or if direct and indirect exposure of the aquatic compartment is unlikely. The partition coefficient of KEL 3587 was determined in a reliable study (Frischman 2012) where the measured Kow is <=- 0.46. Therefore, KEL 3587 is considered to have low potential for bioaccumulation. Additionally, the substance is rapidly biodegradable and therefore, exposure to aquatic organisms is unlikely. No further testing is required.

 

Transport and distribution of KEL3587: 

Waiver. In accordance with column 2 of REACH Annexes XIII, the adsorption / desorption study (required in section 9.3.1 and 9.3.3) do not need to be conducted if, based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient). The partition coefficient of KEL 3587 was determined in a reliable study (Frischman 2012) where the measured log Kow is <=- 0.46. Therefore, KEL 3587 is considered to have low potential for absorption and no further testing is required.

 

Waiver. In accordance with the REACH Regulations, determination of Henry’s Law constant is not a standard information requirement.

 

Waiver. In accordance with the REACH Regulations distribution is not a standard information requirement