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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
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity: Weight of evidence. Based on the available information for the read-across approach, the target substance has an oral LD50 > 10000 mg/kg bw.
Acute Inhalation Toxicity: Data waiving (study
scientifically not necessary / other information available): According
to column 2 of REACH Annex VIII, the study does not need to be
conducted, as data for both oral and dermal routes is available.
Acute Dermal Toxicity: Data waiving (study
scientifically not necessary / other information available): According
to column 2 of REACH Annex VII, the study does not need to be conducted
if the substance does not meet the criteria for classification as acute
toxicity or STOT SE by the oral route, and no systemic effects have been
observed / are predicted for studies with dermal exposure.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- 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. - 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: 6 or 8 weeks, 12 or 16 weeks and 1 week old. The LD50 were compared in the three stages of growth.
- Weight at study initiation: 6-8 weeks: (6 weeks old: males =1 80-200 g, females = 110-130 g ; 8 weeks old: males = 220-290 g, females = 160-195 g), 12-16 weeks (body weight: 12 to 23 weeks old male 300 to 350 g, female 200 to 240 g, 16 week old male 400 to 450 g); 1 week: one male, 13 to 25 g.
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2ºC
- Humidity (%): 60 ± 5% - Route of administration:
- oral: unspecified
- Vehicle:
- water
- Doses:
- 8 and 10 g/kg-bw
- No. of animals per sex per dose:
- 7 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic observations. - Statistics:
- Litchfield-Wilcoxon's method.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 8 weeks old rats
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: Mild locomotor suppression was the only transient effect observed.
- Gross pathology:
- No macroscopic abnormalities.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria
- Conclusions:
- The oral LD50 of the test item in rats was > 10000 mg/kg-bw.
- Executive summary:
An acute oral 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 p.o. to two groups of 7 rats per sex at doses of 8.0 and 10.0 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. No mortalities occured, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was found to be > 10 g/kg-bw in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See "attached justification". - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 592.6 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: read-across from analogue.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- Based on the available information for the read-across approach, the oral LD50 of the target substance in rats is deemed > 9.5 g/kg bw.
- Executive summary:
An acute oral toxicity study was conducted on the sodium salt of piperacillin, 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 p.o. to two groups of 7 rats per sexat doses of 8.0 and 10.0 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. No mortalities occured, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was determined to be > 10 g/kg bw in rats. Based on the available information for the read-across approach, the oral LD50 of the target substance in rats is deemed > 9.5 g/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- 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. - Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Laboratory Animal Agricultural Cooperatives
- Age at study initiation: 5 weeks.
- Weight at study initiation: 20-25g
- Diet: Solid feed (Oriental MF) ad libitum
- Water: tap water ad libitum
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2ºC
- Humidity (%): 60 ± 5% - Route of administration:
- oral: unspecified
- Vehicle:
- water
- Doses:
- 10 g/kg-bw
- No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic observations. - Statistics:
- Litchfield-Wilcoxon's method.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Transient mild motor suppression.
- Gross pathology:
- No macroscopic abnormalities.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria
- Conclusions:
- The LD50 of the test item was greater than 10000 mg/kg-bw in mice.
- Executive summary:
An acute oral toxicity study was conducted in order to determine the toxicological properties of the test item with a method similar to OECD guideline 401 (non-GLP). A limit test was conducted by administering the test item p.o. to one group of 10 mice per sex at a dose of 10.0 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. No mortalities occured, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was found to be > 10 g/kg-bw in mice.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See "attached justification". - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 592.6 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: read-across from analogue.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria
- Conclusions:
- Based on the available information for the read-across approach, the oral LD50 of the target substance in mice is deemed to be > 9.5 g/kg-bw.
- Executive summary:
An acute oral 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). A limit test was conducted by administering the test item p.o. to one group of 10 mice per sex at a dose of 10.0 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. No mortalities occured, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was found to be > 10 g/kg-bw in mice. Based on the available information for the read-across approach, the oral LD50 of the target substance in mice is deemed to be > 9.5 g/kg-bw.
Referenceopen allclose all
Table 1. Death rate in acute toxicity tests of T-1220.
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 |
|||
8.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
10.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
Table 2. Summary of results.
Animal |
Route |
Age |
LD50 (g/kg) |
|
Male |
Female |
|||
Rat |
p.o. |
8w |
> 10 |
> 10 |
Table 1. Death rate in acute toxicity tests of T-1220.
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 |
|||
10.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
Table 2. Summary of results.
Animal |
Route |
Age |
LD50 (g/kg) |
|
Male |
Female |
|||
Mouse |
p.o. |
5w |
> 10 |
> 10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
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
Acute Oral Toxicity. Weight of evidence: Based on the available information for the read-across approach, the target substance has an oral LD50 > 9500 mg/kg bw.
An acute oral toxicity study was conducted with the sodium salt of piperacillin, by a method similar to OECD TG 401 (non-GLP), by p.o. administration of the test item at doses of 8.0 and 10.0 g/kg-bw to two groups of 7 male and 7 female rats each. Mortalities and clinical signs were monitored during 7 days post-dosing after which animals were necropsied and subjected to a gross examination. No mortalities occurred, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was determined to be > 10 g/kg-bw in rats. Based on the available information for the read-across approach, the oral LD50 of the target substance in rats is deemed > 10 g/kg bw.
Another acute oral toxicity study was conducted with the sodium salt of piperacillin by a method similar to OECD TG 401 (non-GLP). A limit test was conducted by administering the test item p.o. to one group of 10 mice per sex at a dose of 10.0 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. No mortalities occurred, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was found to be > 10 g/kg-bw in mice. Based on the available information for the read-across approach, the oral LD50 of the target substance in mice is deemed to be > 10 g/kg-bw. Based on the available information for the read-across approach, the target substance has an oral LD50 > 9500 mg/kg bw.
Justification for classification or non-classification
Based on the available information (oral LD50 > 10000 mg/kg bw), the
substance is not classified for acute toxicity according to CLP
Regulation (EC) No. 1272/2008.
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