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Environmental fate & pathways

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The ready biodegradability of Biofert Plusz was investigated in a study conducted according to OECD Guideline 301 B over a period of 28 days and using non-adapted activated sludge as inoculum source. The biodegradation rate was determined by measurement of CO2 evolution. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using 80 mg/L test material and 20 mg/L reference compound were performed. Biofert Plusz proved to be readily biodegradable and fulfilling the 10-d window criterion (92% biodegradation after 28 d). The functional control reached the pass level >60% after 14 d. In the toxicity control containing both test and reference substance 81% biodegradation based on ThCO2 occurred within 14 d thus indicating that the test item was not inhibitory at the concentration tested.

Experimentally derived values on hydrolysis and photooxidation of Biofert are not available. In Annex VIII of Regulation (EC) No 1907/2006, it is laid down that further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. According to reliable study results, Biofert Plusz is considered to be rapidly biodegraded in the environment and the bioaccumulation potential is regarded to be insignificant. Therefore, the performance of experimental studies on hydrolysis or photodegradation are assumed to be scientifically not justified.

Henry's Law constant of L-threonine as the main constituent of Biofert plusz was calculated using EPIWIN (v4.0), HENRYWIN (v3.20). The calculation of Henry's Law constant according to the equation H=vp/ws yielded a value of 7.34E-009 Pa x m3/mole using an estimated water solubility of 2.79e+005 mg/l and a vapour pressure of 7.88E-009 mm Hg. Based on the result, threonine can be considered as practically non-volatile from aqueous solution.

Experimental studies on adsorption/desorption of Biofert are not available.

According to REACH Regulation (Annex VIII, 9.3.1, column II), a study on adsorption/desorption does not need to be done if the the test material is readily biodegradable.

Biofert Plusz is a complex mixture containing organic and inorganic components (UVCB-substance). Based on the log Kow of the lead component L-threonine (-2.94; Hansch, 1995) the sorption onto sediment organic matter is expected to be negligible. Furthermore, the target compartment of exposure is soil according to the intended uses.

For the bioaccumulation of Biofert Plusz no experimental studies were identified. Biofert Plusz is a complex mixture containing organic and inorganic components (UVCB-substance). L-threonine is the main component of Biofert Plusz. Therefore the bioaccumulation factor of L-Threonine was calculated via EPIWIN v4.0, BCFBAF v3.00. The calculation yielded a BCF=3.162 L/kg ww demonstrating that the substance exhibits no significant bioaccumulation potential.