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The biodegradation potential of TATD-CLE was evaluated by the prediction data generated by Biowin v.4.10[1].

Such estimation may be used for preliminary identification of substances with a potential for persistency. The combined results of the three freely available estimation models BIOWIN 2, 6 and 3 in the EPI suite may be used as follows:

- Non-linear model prediction (BIOWIN 2): does not biodegrade fast (probability < 0.5) and ultimate biodegradation timeframe prediction (BIOWIN 3): ≥ months (value < 2.2), or

- MITI non-linear model prediction (BIOWIN 6): does not biodegrade fast (probability < 0.5) and ultimate biodegradation timeframe prediction (BIOWIN 3): ≥ months (value < 2.2).

Biowin1 (Linear Model): 0.6108

Biowin2 (Non-Linear Model): 0.8721

Expert Survey Biodegradation Results:

Biowin3 (Ultimate Survey Model): 1.0754 (recalcitrant)

Biowin4 (Primary Survey Model): 3.2950 (days-weeks)

MITI Biodegradation Probability:

Biowin5 (MITI Linear Model): -0.1261

Biowin6 (MITI Non-Linear Model): 0.0001

Anaerobic Biodegradation Probability:

Biowin7 (Anaerobic Linear Model): -1.6205

Ready Biodegradability Prediction: NO

In the case of TATD-CLE, the screening criteria show that substance can be regarded as non readly biodegradable and as potentially persistent.

This conclusion is supported by the evaluation of results obtained on the structural analogue Ceftaroline fosamil (EC:/; CAS: 400827-46-5); in the ready biodegradation test, following the OECD guideline 301 procedures, theBOD28was 5% and it was concluded that substance is not readily Biodegradable[2].

Reference

[1]Biowin v.4.10 and BCFBAF v.3.01 are applications contained in the EpiSuite 4.1, the suite of physical/chemical property and environmental fate estimation programs developed by the EPA’s Office of Pollution Prevention Toxics and Syracuse Research Corporation (SRC).

[2]EMA, Committee for Medicinal Products for Human Use (CHMP). Assessment report Zinforo. Ceftaroline fosamil. Procedure No.: EMEA/H/C/002252. 21 June 2012.

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