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Diss Factsheets
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EC number: 248-003-8 | CAS number: 26787-78-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.001 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0 mg/kg sediment dw
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
According to ECHA’s Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment, PNEC for freshwater are estimated by division of the lowest value for the toxicity with the relevant assessment factor.
As stated in the Guidance, blue-green algae should be counted among the primary producers due to their autotrophic nutrition. Moreover, according to the European Medicines Evaluation Agency (EMEA), the use of blue-green algae (Cyanophyta) is recommended for effect assessment of antimicrobials, as they are more sensitive indicator organisms than green algae (EMEA, 2006).
Only short-term aquatic toxicity data on fish and daphnia are available for amoxicillin. The algal growth inhibition test is, in principle, a multi-generation test. However, for purposes of applying the appropriate assessment factors, the EC50 is treated as a short-term toxicity value. Nevertheless, from the toxicity data found in the literature, it could be realized that algae have a higher sensitivity toward amoxicillin compared to crustaceans and fish. Although no long-term toxicity studies to aquatic invertebrates or fish were available in the literature, taking into account the acute toxicity studies performed on crustaceans and fish, amoxicillin seems to be not toxic for these two trophic levels. In regards to aquatic algae, amoxicillin displayed toxicity to the cyanobacterium but showed no toxicity to the green algae. The results indicated that the prokaryotic blue-green algae are considered more sensitive to antibiotics than eukaryotic green algae, most probably due to their structure being more like bacteria.
Taking this information into account, the starting point for PNEC derivation was determined to be the study conducted by Andreozzi et al. (2004) were the 96h-NOEC for S. leopoliensis was determined to be 0.78 µg/mL (worst case scenario). The assessment factor to be applied would be 10 for freshwater and 100 for marine water and intermediate releases, since no effects are expected neither in fish nor aquatic invertebrates in long-term studies.
Conclusion on classification
Based on available data, amoxicillin only shows toxic effects to cyanobacteria most problably due to their structure being more like bacteria (prokaryotic cells). No effects were observed in fish, aquatic invertebrates nor green algae or plants.
According to the Guidance on the Application of the CLP Criteria (Version 4.1 - June 201), where the algal toxicity EC50 falls more than 100 times below the next most sensitive species and results in a classification based solely on this effects, consideration should be given to whether this toxicity is representative of the toxicity to aquatic plants. The obtained data suggest that the use of a single species for assessing the toxicity effects of antibiotics is not realistic and therefore, the substance would not be classified for aquatic toxicity according to CLP Regulation (EC) no. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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