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Diss Factsheets
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EC number: 217-775-8 | CAS number: 1951-97-9
- 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:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- 13-week dietary toxicity study - dogs: piperazine dihydrochloride.
- Author:
- Rutter HA and Voelker RW
- Year:
- 1 975
- Bibliographic source:
- Final report to Jefferson Chemical Co., Austin TX from Hazleton Laboratories America. 13.
- Reference Type:
- other: study report
- Title:
- Committee for Veterinary Medicinal Products - Piperazine - Summary report
- Author:
- EMEA
- Year:
- 1 999
- Bibliographic source:
- The European Agency for the Evaluation of Medicinal Products Veterinary medicines and Inspections; EMEA/MRL/531/98-FINAL MAY 1999
- Reference Type:
- other: study report
- Title:
- European Union Risk Assessment Report : Piperazine
- Author:
- European Chemicals Bureau
- Year:
- 2 005
- Bibliographic source:
- 3rd Priority List Volume: 56;Final Report, 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from 'The European Agency for the Evaluation of Medicinal Products Veterinary medicines and Inspections'
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Piperazine
- EC Number:
- 203-808-3
- EC Name:
- Piperazine
- Cas Number:
- 110-85-0
- IUPAC Name:
- piperazine
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- intermittent
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Dosage levels of 92.3 mg/kg feed(3 mg/kg/day) and 369.2 (12.3 mg/kg/day) for the low and intermediate groups and at 1476.8 mg/kg feed(49.7 mg/kg/day) from week 1 through 5 and 3692 mg/kg feed(121.8 mg/kg/d) from week 6 through 13 for the high level group.
Basis:
no data
- No. of animals per sex per dose:
- Three groups of beagle dogs (4 male and 4 female in each group)
- Control animals:
- yes
- Details on study design:
- Since the high dose of 121.8 mg/kg bw/day of piperazine dihydrochloride was not maintained for the entire administration period,the dose of 49.7 mg/kg bw/day of piperazine dihydrochloride (equivalent to 25 mg/kg bw/day of piperazine base)was considered as the NOEL in dogs.
Examinations
- Observations and examinations performed and frequency:
- No compound related signs of systemic toxicity were observed in any of the test animals with regard to appearance and behaviour,bodyweight changes,ophtalmoscopic finding,organ weights,and gross and microscopic pathology.At 4 weeks and at 13 weeks serum glutamic-oxaloacetic transaminase values fell in the control group whereas they remained constant in treated groups.
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 25 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Induction of mild hepatic involvement in the Beagle dog established.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Upon repeated dose oral administration to beagle dogs, except for some signs of liver toxicity, little evidence of systemic toxicity was observed at the highest tested dose. A NOAEL of 25 mg/kg/day of piperazine base for induction of mild hepatic involvement in the Beagle dog can be established.
- Executive summary:
Upon repeated dose oral administration to beagle dogs, except for some signs of liver toxicity, little evidence of systemic toxicity was observed at the highest tested dose. A NOAEL of 25 mg/kg/day of piperazine base for induction of mild hepatic involvement in the Beagle dog can be established.
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