Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: oral
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.
Repeated dose toxicity: Inhalation
The use of the chemical tripiperazine dicitrate is mostly as an anti-helminthic. Thus, repeated exposure by the inhalation route is highly unlikely and hence this end point was considered for waiver and the chemical is not likely to exhibit repeated dose toxicity by the inhaltion route.
Repeated dose toxicity: Dermal
The use of the chemical tripiperazine dicitrate is mostly as an anti-helminthic. Thus, repeated exposure by the dermal route is highly unlikely and hence this end point was considered for waiver and the chemical is not likely to exhibit repeated dose toxicity by the dermal route.
Based on the available data and the applicable waivers, it can be concluded that the chemical tripiperazine dicitrate is not likely to cause repeated dose toxicity by the oral, inhalation or dermal route of exposure. Thus, the chemical is not likely to be considered for classification.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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
- Critical effects observed:
- not specified
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data from K2 publication.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
The data from various peer reviewed journals have been summarized below to determine the toxic nature of the test compound piperazine citrate (CAS 144-29-6) upon repeated application:
In Key study, a repeated dose subchronic toxicity by Ghasi et al (2012) was conducted where albino Wistar male and female rat were exposed to Piperazine citrate (CAS no 144-29-6) 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 albino Wistar male and female rat were exposed to Piperazine citrate orally for 16 weeks.
In another subchronic repeated dose toxicity study by Ghasi et al (2012), albino wistar rats were treated with Piperazine Citrate in the concentration of 0, 30, 60 and 100 mg/kg/day, results shows that Piperazine Citrate is toxic, toxic changes were observed as change in creatinine,sodium and potassium level in serum when treated with 60 and 100 mg/kg/day. In addition, significant changes were observed in histopathology of kidney such as vascular congestion, shrunken pyknotic and degenerated glomeruli,hyalimisation, glomerular hyaline droplets and necrosis in 60 and 100 mg/kg/day treated rats. Therefore, Low Observed Adverse Effect Level (LOAEL) was considered to be 60 mg/kg day when albino wistar rats were treated with Piperazine Citrate orally in diet for 6 weeks.
In repeated dose toxicity study by Martin et al (1963), albino male and female rat were exposed to 1, 4-Di (D-glucosyl) piperazine (DGP) (CAS no 144-29-6) in a concentration of 0, 1000, 2000 and 3000 mg/kg/day which is equivalent to Piperazine citrate in concentration of 0, 210,420 and 630 mg/kg/day. The results showed that Piperazine citrate was not toxic. No toxic changes were observed on survival, body weight and body weight gain, food consumption and gross pathology of treated rat as compared to control, therefore The No Observed Adverse Effect Level (NOAEL) was considered to be 630 mg/kg/day when albino male and female rat were exposed to Piperazine citrate orally for 10 weeks.
In a repeated dose toxicity study by Brown et al (1956), children with Trichuris trichiura Infections exposed to Piperazine citrate (CAS no 144-29-6) in the concentration of 0.4 g (400 mg/kg/day). The result shows that Piperazine citrate is not effective inTrichuris trichiurainfections. No significant reduction in egg counts of patients with light Trichuris infections was observed.Therefore, No Obsereved Effect Level (NOEL) was considered to be 0.4 g (400 mg/kg/day) when children were exposed to Piperazine citrate orally.
In the same study by Brown et al (1956), patient with Enterobius Infections exposed to Piperazine citrate (CAS no 140-29-6) in the concentration of 1 and 2 gm (1000 and 2000 mg/kg body weight/day). The result shows that Piperazine citrate is curative in Enterobius Vermicularis Infections. Patient treated with different dose of Piperazine citrate shows 97% cure rat of Enterobius infection. Therefore, No Observed Adverse Effect Level (NOAEL) was considered to be1 gm (1000 mg/kg body weight/day) when patient were exposed to Piperazine citrate daily for 7 days.
Repeated dose toxicity: Inhalation
The use of the chemical tripiperazine dicitrate is mostly as an anti-helminthic. Thus, repeated exposure by the inhalation route is highly unlikely and hence this end point was considered for waiver and the chemical is not likely to exhibit repeated dose toxicity by the inhaltion route.
Repeated dose toxicity: Dermal
The use of the chemical tripiperazine dicitrate is mostly as an anti-helminthic. Thus, repeated exposure by the dermal route is highly unlikely and hence this end point was considered for waiver and the chemical is not likely to exhibit repeated dose toxicity by the dermal route.
Based on the overall available data and the applicable waivers, it can be concluded that the chemical tripiperazine dicitrate (piperazine citrate) is not likely to cause repeated dose toxicity by the oral, inhalation or dermal route of exposure. Thus, the chemical is not likely to be considered for classification under Repeated dose toxicity as per CLP classification criteria.
Justification for classification or non-classification
Based on the overall available data and the applicable waivers, it can be concluded that the chemical tripiperazine dicitrate (piperazine citrate) is not likely to cause repeated dose toxicity by the oral, inhalation or dermal route of exposure. Thus, the chemical is not likely to be considered for classification under Repeated dose toxicity as per CLP classification criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.