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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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- 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 per reviewed publication
- Objective of study:
- toxicokinetics
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Modified colorimetric method: The aim of this study was to compare the amount of piperazine excreted in the urine over 24 hr. after oral administration of a newly developed syrup formula, equivalent to 3.5 g. piperazine hexahydrate, against a commercial syrup sample. This dose was chosen according to the normal adult dose range for the treatment of ascariasis.
- Radiolabelling:
- no
- Species:
- other: Human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five Caucasian subjects, three men and two women ranging from 23 to 38 years of age, in normal state of health as determined by prior physical and laboratory medical examination, were used in this trial
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- an oral dosage of 35 ml. of piperazine citrate syrup equivalent to 3.5 g. piperazine hexahydrate was administered to five Caucasian subjects
- Duration and frequency of treatment / exposure:
- 24 hrsFrequency was a single dose
- Dose / conc.:
- 20 other: mcg./ml
- No. of animals per sex per dose / concentration:
- 5 (three men and two women)
- Control animals:
- no
- Positive control reference chemical:
- not specified
- Details on study design:
- Prior to the oral administration of either syrup sample, a urine sample was collected from each individual to be used as an internal control.
- Details on dosing and sampling:
- not specified
- Statistics:
- not specified
- Details on absorption:
- Readily absorbed from the GI tract
- Details on distribution in tissues:
- not specified
- Details on excretion:
- Urinary excretion began 1 hr after the oral administration, and the rate was maximal between 2 and 6 hr. Excretion was nearly completed in 24 hr. Within 24 hours between 60 to 75% of the administered dose was excreted. The total urinary recovery of piperazine varied from 15 to 75%.
- Toxicokinetic parameters:
- other: not specified
- Metabolites identified:
- not specified
- Bioaccessibility (or Bioavailability) testing results:
- not specified
- Conclusions:
- Piperazine citrate was readily absorbed from the GI tract. Urinary excretion began 1 hr after the oral administration, and the rate was maximal between 2 and 6 hr. Excretion was nearly completed in 24 hr. Within 24 hours between 60 to 75% of the administered dose was excreted. The total urinary recovery of piperazine varied from 15 to 75%. Thus, the bio-accumulation potential of piperazine citrate in the human body is likely to be low.
- Executive summary:
A modified colorimetric method using Folin's amino acid reagent was used for the quantitative determination of piperazine in human urine. Comparative urinary excretion trials were carried out on five subjects using two different piperazine citrate syrup formulas. The aim of this study was to compare the amount of piperazine excreted in the urine over 24 hr after oral administration of a newly developed syrup formula, equivalent to 3.5 g. piperazine hexahydrate, against a commercial syrup sample. This dose was chosen according to the normal adult dose range for the treatment of ascariasis. Five Caucasian subjects, three men and two women ranging from 23 to 38 years of age, in normal state of health as determined by prior physical and laboratory medical examination, were used in this trial. Each was administered an oral dosage of 35 ml. of piperazine citrate syrup equivalent to 3.5 g. piperazine hexahydrate. At least 48 hr. elapsed between the administration of the new formula and the commercial sample. Prior to the oral administration of either syrup sample, a urine sample was collected from each individual to be used as an internal control. Urine samples were collected. whenever possible, at 1, 2.5, 4.5. 6.5, 9, 13, 20, and 24 hr. after oral administration.
Piperazine citrate was readily absorbed from the GI tract. The percentage and pattern of urinary excretion of piperazine calculatedashexahydrate varied from individual to individual, as seen in the five subjects. Urinary excretion began 1 hr after the oral administration, and the rate was maximal between 2 and 6 hr. Excretion was nearly completed in 24 hr. Within 24 hours between 60 to 75% of the administered dose was excreted. The total urinary recovery of piperazine varied from15to75%. Thus, the bio-accumulation potential of piperazine citrate in the human body is likely to be low.
Reference
Description of key information
Piperazine citrate was readily absorbed from the GI tract. Urinary excretion began 1 hr after the oral administration, and the rate was maximal between 2 and 6 hr. Excretion was nearly completed in 24 hr. Within 24 hours between 60 to 75% of the administered dose was excreted. The total urinary recovery of piperazine varied from 15 to 75%. Thus, the bio-accumulation potential of piperazine citrate in the human body is likely to be low.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
Basic toxicokinetics:
Two different experimental studies of the test substance pieprazine citrate were reviewed for basic toxicokinetics endpoint which are summarised as follows:
In key study a modified colorimetric method using Folin's amino acid reagent was used by S. Hanna. and A. Tang, Journal of pharmaceutical sciences Vol. 62, No. 12, December 1973, for the quantitative determination of piperazine in human urine. Comparative urinary excretion trials were carried out on five subjects using two different piperazine citrate syrup formulas. The aim of this study was to compare the amount of piperazine excreted in the urine over 24 hr after oral administration of a newly developed syrup formula, equivalent to 3.5 g. piperazine hexahydrate, against a commercial syrup sample. This dose was chosen according to the normal adult dose range for the treatment of ascariasis. Five Caucasian subjects, three men and two women ranging from 23 to 38 years of age, in normal state of health as determined by prior physical and laboratory medical examination, were used in this trial. Each was administered an oral dosage of 35 ml. of piperazine citrate syrup equivalent to 3.5 g. piperazine hexahydrate. At least 48 hr. elapsed between the administration of the new formula and the commercial sample. Prior to the oral administration of either syrup sample, a urine sample was collected from each individual to be used as an internal control. Urine samples were collected. whenever possible, at 1, 2.5, 4.5. 6.5, 9, 13, 20, and 24 hr. after oral administration. Piperazine citrate was readily absorbed from the GI tract. The percentage and pattern of urinary excretion of piperazine calculatedashexahydrate varied from individual to individual, as seen in the five subjects. Urinary excretion began 1 hr after the oral administration, and the rate was maximal between 2 and 6 hr. Excretion was nearly completed in 24 hr. Within 24 hours between 60 to 75% of the administered dose was excreted. The total urinary recovery of piperazine varied from15 to75%.
In a supporting comparative studies, as cited in The MAK Collection for Occupational Health and Safety. 304 – 313; 2013, 8 healthy volunteers (3 male, 5 female) were given single oral doses of piperazine adipate or citrate equivalent to a dose of 1000 mg anhydrous piperazine. The proportion of the dose excreted in the 24-hour urine was 32.1 ± 9.5 % (adipate) and 33.2 ± 8.3 % (citrate). Three days after dosing, not even traces of piperazine were detected in the urine.
Thus from the results of the above mentioned studies it can be concluded that the bio-accumulation potential of piperazine citrate in the human body is likely to be very low as it is excreted in urine.
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