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EC number: 205-622-8 | CAS number: 144-29-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Impact of Subchronic Administration of Piperazine Citrate on the Electrocardiogram of the rat
- Author:
- Samuel Ghasi, Anthovy Ogbonna, and Anthony Mbah
- Year:
- 2 012
- Bibliographic source:
- American Journal of Therapeutics 19, 81-87, (2012)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Impact of Subchronic toxcity study of Piperazine Citrate on the Electrocardiogram of the rat orally.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tripiperazine dicitrate
- EC Number:
- 205-622-8
- EC Name:
- Tripiperazine dicitrate
- Cas Number:
- 144-29-6
- Molecular formula:
- C6H8O7.3/2C4H10N2
- IUPAC Name:
- piperazine 2-hydroxypropane-1,2,3-tricarboxylate (3:2) (salt)
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- other: Albino Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animalTEST ANIMALS- Source: No data available - Age at study initiation: No data available- Weight at study initiation: 200 – 250 g - Fasting period before study: No data available - Housing: No data available- Diet (e.g. ad libitum): Standard diet, ad libitum - Water (e.g. ad libitum): No data available - Acclimation period: No data available ENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): No data available IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Standard diet
- Details on oral exposure:
- Details on oral exposurePREPARATION OF DOSING SOLUTIONS: No data available DIET PREPARATION- Rate of preparation of diet (frequency): No data available - Mixing appropriate amounts with (Type of food): No data available - Storage temperature of food: No data available VEHICLE- Justification for use and choice of vehicle (if other than water): Standard diet - Concentration in vehicle: 0, 30, 60 and 100 mg/kg/body weight/day - Amount of vehicle (if gavage): No data available - Lot/batch no. (if required): No data available - Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- Two times a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 30, 60 and 100 mg/kg/body weight/day Basis:nominal in diet
- No. of animals per sex per dose:
- Total : 40 0 mg/kg/body weight/day: 10 sex matched rat 30 mg/kg/body weight/day: 10 sex matched rat 60 mg/kg/body weight/day: 10 sex matched rat 100 mg/kg/body weight/day: 10 sex matched rat
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for animal assignment (if not random): On the basis of matched sex
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- OTHER: Effects on electrocardiogram of heart were observed.
- Sacrifice and pathology:
- No data available
- Other examinations:
- Effects on electrocardiogram of heart:Approximately 1 hour after last dose rat were anesthetized with thiopentone sodium (50mg/kg intaperitoneally) and placed in supine position with all four limbs tied onto dissectine board.Observation:Heart rat, atrial and atrioventricular conduction and cardiac dysthythmic phenomena were observed.
- Statistics:
- Averages were expressed as arithmetic mean ± standard error of the mean. Student t test were performed comparing the results obtained from each drug concentration with measurements from control experiments and a p value of < 0.05 taken as indicating a statistically significant difference. Analysis of variance was then performed to evaluate differences between the three test grou[p using a one-way analysis of variance.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Effect on heart rate:When treated with 30 mg/kg/body weight /day, the average heart rate at the end of 15 minute was observed and no statistically significant difference were observed in treated and control rat.Atrial and atrioventricular conduction: The p wave for the 30 and 60 mg/kg body weight/day and control remained unaltered at 40 ms. P-R interval :When treated with 30, 60 and 100 mg/kg body weight/day, P-R interval was statistically significantly increased as compared to control.QTc interval: When treated with 60 and 100 mg/kg/body weight/day, statistically significant difference was observed as compared to control.J-T interval of 120 ms:Statistically significant difference was observed in 30, 60 and 100 mg/kg/body weight /day treated rat as compared to control.T wave amplitude:Statistically significant increased was observed in average T wave amplitude of 100 mg/kg/body weight/day treated rat as compared to control. R wave amplitude:Statistically significant increased was observed in average R wave amplitude of 30,60 and 100 mg/kg/body weight/day treated rat as compared to control. Cardiac dysthythmic phenomena:When treated with 30, 60 and 100 mg/kg body weight/day, statistically significant change in R, T and QRS-T complex and dose dependent electrocardiographic change were observed in treated rat as compared to control.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on electrocardiogram of rat heart
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) was considered to be 100 mg/kg body weight/day when albino Wistar male and female rat exposed to Piperazine citrate. Based on the results, it can be concluded that the chemical piperazine citrate is not likely to cause repeated dose toxicity by the oral route of exposure as per CLP classification criteria.
- Executive summary:
In a repeated dose subchronic toxicity study, albino Wistar male and female rat were exposed to Piperazine citrate in the concentration of 30, 60 and 100 mg/kg body weight/day. The results showed that Piperazine citrate was not toxic. No toxic change were observed in Electrocardiogram of treated rat. Some significant changes were observed in atrial and atrioventricular conduction, P-R interval, QTc interval, J-T interval, T and R wave amplitude and Cardiac dysthythmic phenomena of treated rat but the changes were non toxic. No ECG abnormalities were observed at the end of study. Therefore, the No Observed Adverse Effect Level (NOAEL) was considered to be 100 mg/kg body weight/day when albinoWistar male and female rat were exposed to Piperazine citrate orally for 16 weeks. Based on the results, it can be concluded that the chemical piperazine citrate is not likely to cause repeated dose toxicity by the oral route of exposure as per CLP classification criteria.
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