Registration Dossier
Registration Dossier
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EC number: 939-996-5 | CAS number: 689294-28-8
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- no hazard identified
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no hazard identified
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Additional information
No experimental nor literature based ecotoxicological 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
Data available are consistent for both the substances, except for the Anabaena fols-aquae algae data.
TATD-CLE is expected to be non-rapidly degradable. Chronic toxicity data are available on structural analogues, nevertheless some grounds of concern can not be excluded, considering the nature of the substance and its action as bactericidal. Thus, in order to apply a precautionary approach, a classification in the safety net category (aquatic chronic 4, H413) according to the CLP regulation is proposed.
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.
Conclusion on classification
The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and long-term hazard of a substance. The core classification system for substances consists of one acute hazard classification category and three long-term hazard classification categories. The system also introduces a “safety net” classification (referred to as category Chronic 4) for use when the data available do not allow classification under the formal criteria for acute 1 or chronic 1 to 3, but there are nevertheless some grounds for concern.
TATD-CLE is expected to be non-rapidly degradable.
Chronic toxicity data are available on structural analogues, nevertheless some grounds of concern can not be excluded, considering the nature of the substance and its action as bactericidal. Thus, in order to a precautionary approach, a classification in the safety net category (aquatic chronic 4, H413) according to the CLP regulation is proposed.
In conclusion, according to CLP regulation (EC1272/2008) TATD-CLE is classified as: Aquatic Chronic 4 (H413)
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