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Diss Factsheets
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EC number: 615-984-2 | CAS number: 73547-70-3
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: predictions from Basic Data set
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A qualitative assessment of the toxicokinetics of the substance has been performed, based upon its physical properties and the results of toxicological studies.
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance Version 2.0 November 2014
- GLP compliance:
- no
- Radiolabelling:
- no
- Metabolites identified:
- not specified
- Bioaccessibility (or Bioavailability) testing results:
- key physical properties:
Molecular weight: 619.51
Water solubility: >1000 g/L
Partition co-efficient log Pow: -3.36
Particle size distribution: 90% (<89 µm), 50% (<5.7 µm), 10% (<0.147 µm)
Dissociation constant: not determined
pH (10% suspension ): 1.2
Hydrolysis: not determined inherently biodegradable - Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
oral: clinical signs witnessed in the repeat dose oral toxicity study indicates that the substance is absorbed following administration in polyethylene glycol with systemic effects noted: clinical chemistry and liver following exposure to all dose levels. NO toxicologically significant effects were observed on reproductive or developmental parameters in the exposed animals.
The water solubility, partition coefficient and molecular mass all indicate that this substance will be bioavailable via the oral route.
Inhalation: The particle size distribution indicates that there is potential for exposure by this route.
Dermal absorption: the physical parameters of the substance:pH, molecular weight and log Pow, indicate that the substance will disrupt the stratum corneum and underlying epidermis/dermis and be systemically available from dermal exposure.
Metabolism: There is some evidence from the 28 day study to indicate that the substance is undergoing hepatic metabolism (increases in serum cholesterol and ALAT).
Excretion: There is limited evidence from the oral toxicity studies conducted ( increase (p<0.05) in potassium concentration and a statistically significant reduction (p<0.05) in
calcium concentration. ,and increases in absolute and relative kidney weights in males in repeat dose studies) that the substance may interact with the kidneys.
Reference
acute oral toxicity: discriminating dose 2000 mg/kg.
Reproductive Toxicity Screen (OECD422): No toxicologically significant effects on fertility, reproductive performance or pup development were noted up to the maximum dose tested (750 mg/kg bw/day).
28 day repeat dose oral toxicity (OECD422) :
The oral administration of Ceftazidime dihydrochloride to rats by gavage, at dose levels of
50, 200 and 750 mg/kg bw/day, resulted in reduced body weight gains in males treated with
750 mg/kg bw/day and microscopic liver changes in animals of either sex treated with
750 mg/kg bw/day and in males treated with 200 mg/kg bw/day. The ‘No Observed Effect
Level’ (NOEL) for systemic toxicity was therefore considered to be 200 mg/kg bw/day for
females and 50 mg/kg bw/day for males.
The increased cytoplasmic rarefaction in the liver of males was most likely due to variation in
glycogen storage within the cells and is generally considered to be an adaptive response,
therefore, a No Observed Adverse Effect Level (NOAEL) for males was considered to be
200 mg/kg bw/day.
Males treated with 750 mg/kg bw/day showed statistically significant increases (p<0.05) in
cholesterol, alanine aminotransferase and albumin/globulin ratio and a statistically significant
reduction (p<0.05) in total protein.
Males from all treatment groups showed statistically significant reductions (p<0.05-0.01) in
alkaline phosphatase and bile acids. With the exception of one individual alkaline
phosphatase value at 750 and 200 mg/kg bw/day, all remaining values were within the
historical control ranges and therefore were considered not to be of toxicological importance.
Males treated with 750 and 200 mg/kg bw/day also showed a statistically significant increase
(p<0.05) in potassium concentration and a statistically significant reduction (p<0.05) in
calcium concentration. The majority of individual values were within the historical control
ranges and in the absence of a true dose related response, the intergroup differences were
considered not to be of toxicological importance.
Females treated with 750 and 200 mg/kg bw/day showed a statistically significant reduction
in bile acids. Females treated with 750 mg/kg bw/day also showed statistically significant
increases (p<0.05-0.01) in albumin and albumin/globulin ratio. All of the individual values
were within the historical control ranges, therefore, the intergroup differences were
considered not to be of toxicological importance.
skin exposure: The substance is considered to be corrosive given the pH of 1.2
eye exposure: The substance is considered to be corrosive given the pH of 1.2
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.