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EC number: 262-811-8 | CAS number: 61477-96-1
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test:
method for assessing acute toxicity that involves the identification of a dose level that causes evidence of non-lethal toxicity.
- Short description of test conditions: The test item was administered i.v. to groups of 7 Wistar SPF rats per sex (8 or 16 weeks old) at 12 doses ranging from 1.81 to 3.54 g/kg bw test item.
- Parameters analysed / observed: Mortalities and clinical signs were monitored during 7 days post-dosing after which animals were necropsied and subjected to a gross examination. - GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-, monosodium salt, [2S-[2α,5α,6β(S*)]]-
- EC Number:
- 261-868-6
- EC Name:
- 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-, monosodium salt, [2S-[2α,5α,6β(S*)]]-
- Cas Number:
- 59703-84-3
- Molecular formula:
- C23H26N5O7S.Na
- IUPAC Name:
- sodium;(2S,5R,6R)-6-[(2S)-2-[4-ethyl-2,3-dioxopiperazin-1-yl)carbonylamino]-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dilution with water.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nippon CLEA Co., Ltd.
- Age at study initiation: 8 and 16 weeks old. The LD50 were compared in the stages of growth.
- Weight at study initiation: 8 weeks: (8 weeks old: males = 220-290 g, females = 160-195 g), 16 weeks (body weight: males 400 to 450 g).
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2ºC
- Humidity (%): 60 ± 5%
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- water
- Doses:
- 12 doses from 1810 mg/kg bw to 3540 mg/kg-bw
- No. of animals per sex per dose:
- 7
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days.
- Frequency of observations and weighing: daily observations.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic observations. - Statistics:
- 95% confidence limits were calculated by Litchfield-Wilcoxon’s method.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 710 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 360 - <= 3 120
- Remarks on result:
- other: 8 weeks old
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 790 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 210 - <= 3 500
- Remarks on result:
- other: 16 weeks old
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 260 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 100 - <= 2 430
- Remarks on result:
- other: 16 weeks old
- Mortality:
- No mortality was observed.
- Clinical signs:
- At 2000 mg/kg bw, only a decrease in hyperactive locomotor activity was observed.
At 2660 mg/kg bw, transient effects that included lack of control of limb movement and unresponsiveness to stimulae for about 30 min post-administration. The surviving animals recovered about 2h after administration. 4 males and 3 females in this group showed ankylosing convulsions for 15-30 min, and died. - Gross pathology:
- At necropsy of the dead animals of the 2660 mg/kg bw group, pulmonary haemorrhage and mild subdural haemorrhage of the brain were found in most cases. These were not observed at necropsy of the surviving animals of the same group.
Any other information on results incl. tables
Table 1. Death rate in acute toxicity tests of T-1220. Rat, i.v.
Age |
Dose (g/kg) |
Male |
Female |
||||||||||||||||
Time in days |
Death rate |
Time in days |
Death rate |
||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||||
8 w |
3.54 |
7 |
|
|
|
|
|
|
|
7/7 |
7 |
|
|
|
|
|
|
|
7/7 |
3.22 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6/7 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7/7 |
|
2.93 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4/7 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4/7 |
|
2.66 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4/7 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3/7 |
|
2.42 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/7 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3/7 |
|
2.20 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
|
2.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
|
16 w |
2.66 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7/7 |
|
|
|
|
|
|
|
|
|
2.42 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5/7 |
|
|
|
|
|
|
|
|
|
|
2.20 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3/7 |
|
|
|
|
|
|
|
|
|
|
2.00 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/7 |
|
|
|
|
|
|
|
|
|
|
1.81 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
|
|
|
|
|
|
|
|
|
Table 2. Summary of results.
Animal |
Route |
Age |
LD50 (g/kg) |
|
Male |
Female |
|||
Rat |
i.v. |
8 wk |
2.71 (2.36 – 3.12) |
2.79 (2.21 – 3.50) |
16 wk |
2.26 (2.10 – 2.43) |
|
*(): 95% confidence limits, calculated by Litchfield-Wilcoxon’s method.
Applicant's summary and conclusion
- Conclusions:
- The intravenous LD50 of the test item in rats was > 2000 mg/kg-bw.
- Executive summary:
An acute intravenous toxicity study was conducted in order to determine the toxicological properties of the sodium salt of piperacillin with a method similar to OECD guideline 401 (non-GLP). The test item was administered i.v. to groups of 7 Wistar SPF rats per sex (8 or 16 weeks old) at 12 doses ranging from 1.81 to 3.54 g/kg bw test item. Mortalities and clinical signs were monitored during 7 days post-dosing after which animals were necropsied and subjected to a gross examination. All animals died at the highest dose tested, and toxic effects were observed until 2.66 g/kg bw. At 2.00 g/kg bw no mortalities occured, the clinical signs were limited to mild transient locomotor supression, no gross abnormalities were observed at necropsy. The intravenous LD50 was found to be > 2000 mg/kg bw in rats.
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