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Diss Factsheets
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EC number: 213-485-0 | CAS number: 957-68-6
- 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
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- <=2017
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- fish embryo acute toxicity (FET)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- <=2017
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- A short-term toxicity test with embryos and larvae of Zebrafish is described, reporting a low toxicity.
- Executive summary:
7 -ACA and other impurities of cefazolin were investigated in embryos and larvae of Zebrafish after exposure for 3 days.
The lowest LC10 of 0.88 mmol/L corresponds to 240 mg/L and was found for larvae.
The lowest LC50 of 1.32 mmol/L corresponds to 359 mg/L and was found for larvae.
The teratogenic phenotypes after exposure to 7-ACA are smaller head and eyes, poor transparency, and the short body.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 212 (Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages)
- Principles of method if other than guideline:
- Fish embryos and larvae were investigated for short exposure time. 7-ACA and other impurities of Cefazolin were investigated.
- GLP compliance:
- not specified
- Remarks:
- The study was performed in China by a research group.
Test material
- Reference substance name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- EC Number:
- 213-485-0
- EC Name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Cas Number:
- 957-68-6
- Molecular formula:
- C10H12N2O5S
- IUPAC Name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Provided by the National Institutes for Food and Drug Control of China. The structure of each impurity was confirmed by MS and NMR; the HPLC normalized purity was >93%.
Sampling and analysis
- Analytical monitoring:
- not specified
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test substance solution was prepared in breeding water. Zebrafish breeding water was prepared with Instant Ocean sea salt.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Zebrafish wild type (WT) embryos at 6 hours post-fertilisation (hpf) and larvae at 3 days post-fertilisation (dpf) were used.
Study design
- Test type:
- semi-static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 3 d
- Remarks on exposure duration:
- Organogenesis occurs at period of 6–72 hpf.
- Post exposure observation period:
- no.
Test conditions
- Hardness:
- Not specified.
- Test temperature:
- Not specified.
- pH:
- Not specified.
- Dissolved oxygen:
- Not specified.
- Salinity:
- Yes.
- Conductivity:
- Not specified.
- Nominal and measured concentrations:
- Not specified.
- Details on test conditions:
- Both embryos and larvae were immersed, respectively, in 3–4 mL of the drug testing solutions (drugs were dissolved in breeding water) in a 20-mm dish for 3 days (organogenesis at period of 6–72 hpf), but the solutions for the treatment of the larvae were replaced every 24 h, and zebrafish were observed under a microscope. Three or four concentrations for the administered groups were used for each compound.
- Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 3 d
- Dose descriptor:
- other: Toxic dose TD10
- Effect conc.:
- 2.6 mmol/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: embryotoxicity
- Duration:
- 3 d
- Dose descriptor:
- other: TD50 (toxic dose)
- Effect conc.:
- 9.3 mmol/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: embryotoxicity
- Duration:
- 3 d
- Dose descriptor:
- LC10
- Effect conc.:
- 16.8 mmol/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- of embryos
- Duration:
- 3 d
- Dose descriptor:
- LC50
- Effect conc.:
- 48.7 mmol/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- of embryos
- Duration:
- 3 d
- Dose descriptor:
- LC10
- Remarks:
- Larval lethality
- Effect conc.:
- 0.88 mmol/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- of larvae
- Duration:
- 3 d
- Dose descriptor:
- LC50
- Remarks:
- mortality of larvae
- Effect conc.:
- 1.32 mmol/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- of larvae
- Details on results:
- The lowest LC10/TD10 of 0.88 mmol/L corresponds to 240 mg/L.
The lowest LC50/TD50 of 1.32 mmol/L corresponds to 359 mg/L.
The teratogenic phenotypes after exposure to 7-ACA are smaller head and eyes, poor transparency, and the short body.
Applicant's summary and conclusion
- Executive summary:
7 -ACA and other impurities of cefazolin were investigated in embryos and larvae of Zebrafish after exposure for 3 days.
The lowest LC10 of 0.88 mmol/L corresponds to 240 mg/L and was found for larvae.
The lowest LC50 of 1.32 mmol/L corresponds to 359 mg/L and was found for larvae.
The teratogenic phenotypes after exposure to 7-ACA are smaller head and eyes, poor transparency, and the short body.
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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