Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Stability 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 FX511 in the environment.

 

Biodegradation:

A reliable measured biodegradation study in water for FX511 is available and included in the dossier. Reliable studies on the biodegradation in sediment and soil are not available, however waivers are applied for these endpoints.

 

A reliable measured biodegradation study for FX511 is available and included in the dossier. Clark (2012) conducted a reliable (Klimisch 1) GLP compliant study according to OECD 301 B (CO2 Evolution Test) method. The biodegradability of FX511 exposed to microorganisms derived from activated sludge obtained from a municipal wastewater treatment plant was investigated under aerobic exposure conditions. After 28 days the test substance showed 92% degradation, with an initial test concentration of 10 mgC/L. Greater than 60% degradation occurred within 10 day window confirming that FX511 can be considered to be readily biodegradable, 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 soil is unlikely or if the substance is readily biodegradable. Exposure potential is expected to be unlikely as substance is readily biodegradable. In the environment, ready biodegradability means it can be assumed that FX511 will be biodegraded within the STP process and as a consequence a transfer to the aquatic compartment via STP effluent is not expected. Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biologically degraded in the surface water within a short time. Also, the substance’s low log octanol-water partition coefficient (Log Kow) of 2.98 at a neutral pH indicating low adsorptive potential. Therefore, no additional degradation testing is necessary.

 

Bioaccumulation:

 

Reliable measured bioconcentration information is not available for FX511. In accordance with column 2 of Annex IX of the REACH Regulation (9.3.2 Bioaccumulation in aquatic species) the study need not be conducted if the substance has a low potential for bioaccumulation, specifically where the log Kow is <3. Walker (2012) determined the partition coefficient (Kow) to be 951 and the log Kow to be 2.98, therefore the requirement for a bioaccumulation study is waived.

FX511 is unlikely to bioaccumulate in aquatic organisms. No further testing is required.

Reliable measured bioconcentration information in terrestrial organisms is not available for FX511 and a waiver is applied. 

In accordance with Column 2 of REACH Annex IX, the bioaccumulation test on terrestrial organisms 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 FX511 was determined in a reliable study (Walker 2012) where the measured Kow is 2.98. Therefore, FX511 is considered to have low potential for bioaccumulation. No further testing is required.

Transport and distribution: 

Reliable measured data for absorption are not available for FX511. In accordance with column 2 of REACH Annex 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 FX511 was determined in a reliable study (Walker 2012) where the measured log Kow is 2.98. Therefore, FX511 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