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

Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 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.
Cross-reference
- Reason / purpose:
- reference to same study
Reference
- 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:
- 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 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Single-dose toxicity studies of tazobactam/piperacillin and tazobactam
- Author:
- Hayashi T; Yada H; Anai M; Umano T; Kawazu K; Anai S; Kaziwara T; Yamasaki K.
- Year:
- 1 994
- Bibliographic source:
- J. Toxicol Sci. 1994, Oct; Vol 19, Suppl 2, pp 145-53.
Materials and methods
- GLP compliance:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Name in the publication: (+)-(2S, 3S, %R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide.
No further details are provided in the English text. The Japanese text of the publication obviously contains some information.
Test animals
- Details on test animals and environmental conditions:
- Rats, mice and dogs were used.
Administration / exposure
- Route of administration:
- other: p.o., i.v., i.p., s.c.
- Details on exposure:
- Peroral, i.p, s.c. and i.v. administration was performed in male and female rats and mice.
Intravenous administration was performed in male dogs. - No. of animals per sex per dose:
- 7.
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: peroral, mouse and rat
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: subcutaneous, mouse and rat
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: intraperitoneal, mouse and rat
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: intravenous, mouse and rat
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: intravenous, dog
- Mortality:
- None in rats, mice and male dogs at 5000 mg/kg bw and peroral, subcutaneous, intraperitoneal or intravenous administration.
- Clinical signs:
- Soft stool, decreased spontaneous motor activity and/or decreased respiratory rate for the i.p, s.c and i.v. route. Tremor in mice and clonic convulsion in rats before death, in the intravenously dosed animals.
Local irritation or necrosis at the injection site.
In dogs: vomiting, respiratory abnormalities, soft stool and diarrhoea. - Gross pathology:
- Early died rats: hyperaemia, haemorrhage and oedema.
Applicant's summary and conclusion
- Conclusions:
- Only a low toxicity was observed after administration of the test substance by the various routes to mice, rats and dogs.
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