Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

No experimental, nor literature aquatic toxicity data are available on the TATD-CLE, therefore the read across approach was evaluated.

The analogues considered were Cefuroxime (EC: 259-560-1; CAS: 55268-75-2) and Ceftaroline fosamil (EC:/; CAS: 400827-46-5).

 

Cefuroxime was not detected in STP influent and STP and hospital effluent water in Norway[2], and this is the only monitoring conducted in the Nordic countries. Environmental data available are summarized below[1-2,3]:

- Algae S. capricornutum: EC50> 76000 μg/L (72 h) and NOEC ≥ 76000 μg/L

- Daphnia magna, EC50> 831000 μg/L (48 h) and NOEC ≥ 831000 μg/L

- Fish (Oncorhyncus mykiss), a EC50> 100000 μg/L (96 h) and a NOEL > 100000 μg/L was reported.

The PEC/PNEC for Cefuroxime was calculated to be 0.002 (N) and (S).

 

Environmental data available on Ceftaroline fosamil are[4]:

- Algae: Anabaena flos-aquae NOEC = 1.2 µg/L and Pseudokirch-neriella subcapitata NOEC = 33000 µg/L. Both tests were conducted according to the OECD guideline 201

- Daphnia magna: NOEC = 7900 µg/L; test conducted according to the OECD guideline 211

- Fish: NOEC = 5000 µg/L, test conducted according to the OECD guideline 210

Reference

[1]Secondary source:STF, Statens forurensningstilsyn, Oslo. Human and Veterinary Pharmaceuticals, Narcotics, and Personal Care Products in the Environment. Report 2325/2007. Project leader: Martin Schlabach Authors: Merete Grung, Eldbjørg S. Heimstad, Morten Moe, Martin Schlabach, Anders Svenson, Kevin Thomas, Andreas Woldegiorgis.

[2]Thomas, K. V., k. Langford, et al. (2007). SFT report TA-2246/2207. Occurrence of selected pharma-ceuticals in wastewater effluents from hospitals (Ullevål and Rikshospitalet) and VEAS wastewater treatment works. Oslo, SFT, NIVA and NILU: 34 pages.

[3]Läkemedelsindustriföreningen. (2007).

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

Categories Display