Registration Dossier
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EC number: 618-303-7 | CAS number: 89786-04-9
- 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
Description of key information
Acute toxicity: Oral
Key study: Standard acute method. The LD50 in rats was > 5000 mg/kg-bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The paper by Hayashi et al. was published 1994 in a Japanese journal as part of a series of publications on Tazobactam. Only the summary and the Tables are provided in English. Therefore the evaluation restricts to the English parts of the paper. The report provides in the summary and the relevant Table 2 only few details on the method used. Missing information, which might appear in the Japanese text, are: Purity of the test substance; no evidence of the compliance with GLP; age of the animals; etc. The results reported are consistent for the various route of administration and also between the two species rats and mice (no dose and mortality is reported for dogs in the summary). The results are also consistent with those of repeated dose studies reported in the same journal. The NOAEL in the 6-months study in rats after intraperitoneal administration is 40 mg/kg/day. There is enough weight of evidence to state that Tazobactam acid has not to be classified, based on results of an acute oral toxicity study with rats, even if a lot of details of the method is missing in the legible description of the study. A repetition of the available but only partly legible study is therefore not justified; also when observing animal welfare issues.
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Standar acute method
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No details are provided in the English text. The Japanese text of the publication obviously contains some information.
- Doses:
- 5000 mg/kg.
- No. of animals per sex per dose:
- 7.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Statistics:
- Not relevant.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- Clinical sign was soft stool.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- CLP Implementation.
- Conclusions:
- There is enough weight of evidence to state that Tazobactam acid has not to be classified, based on results of an acute oral toxicity study with rats, even if a lot of details of the method is missing in the legible description of the study.
- Executive summary:
The LD50 is >5000 mg test substance / kg bw after oral administration to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Key study is of Klimisch score = 2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Although the studies are only partly legible, because they were written in Japanese, and because the publication do not give extensive information on the methods used, there is enough weight of evidence that Tazobactam acid can be considered to be of low acute toxicity.
Studies with other administration routes, which are more relevant for pharmaceuticals and with other species confirm the low acute toxicity of the notified substance.
Justification for classification or non-classification
Based on the available information, the substance is not classified for acute toxicity according to CLP Regulation.
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