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Diss Factsheets
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EC number: 939-137-4 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study conduct was guideline compliant, however with some deviations. Only 4 animals were used per dose (2 males, 2 females) instead of 5/sex; the skin was abraded, which might have an impact on the permeability of the skin; no purity data were given. Piperazine is one constituent (ca. 15%) of the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- purity not reported, skin is abraded, number of test animals is different
- Principles of method if other than guideline:
- OECD guideline says: at least 5 animals of the same sex per dose group. In this study: 4 animals (2 males, 2 females) are used per dose group.
OECD guideline says: care should be taken to avoid abrading the skin, which could alter its permeability. In this study: the skin of the rabbits were abraded by making 4 epidermal incisions with a clean needle through the stratum corneum. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Piperazine
- EC Number:
- 203-808-3
- EC Name:
- Piperazine
- Cas Number:
- 110-85-0
- Molecular formula:
- C4H10N2
- IUPAC Name:
- piperazine
- Details on test material:
- - Name of test material (as cited in study report): 4236-42-15
- Physical state: light yellow liquld
- Analytical purity: no data reported (responsibility of the sponsor)
- Lot/batch No.: J-82
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglassville, Pennsylvania
- Age at study initiation: adult
- Weight at study initiation: 2.010-2.250 kg
- Housing: individually in cages sized in accordance with the "Guide for the Care of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne Rabbit Ration, ad libitum
- Water: fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk (clipped free of fur)
- % coverage: min. 10%
- Type of wrap if used: rubber dam and an ace bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was done
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 g/kg bw in the preliminary test; 7, 9 and 10 g/kg bw in the main test. - Duration of exposure:
- 24 h
- Doses:
- Preliminary test: 8000 mg/kg bw
Main test for LD50 determination: 7000, 9000 and 10000 mg/kg bw - No. of animals per sex per dose:
- 4 animals per dose (2 male, 2 female)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 min, 2 and 4 hours after 24 h period of exposure and twice daily thereafter for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal signs - Statistics:
- According to the method of Litchfield and Wilcoxon (1949) JPET 96: 99-114.
Results and discussion
- Preliminary study:
- Ten animals were treated with 8000 mg/kg bw; 3/10 animals died.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 8 300 mg/kg bw
- 95% CL:
- 7 300 - 9 400
- Mortality:
- Main test:
7000 mg/kg bw: 1/4 animal died.
9000 mg/kg bw 2/4 animals died.
10000 mg/kg bw: 4/4 animals died. - Clinical signs:
- Cyanosis, diarrhea, salivation, mild convulsions, bleeding from mouth and nose, ataxia, loss of righting, abnormal stance, catatonia, ptosis, and decreased activity were reported. Necropsy of dying animals on study revealed black skin discoloration at application site, with hemorrhage below skin layers and skin necrosis.
- Body weight:
- Normal weight gain was observed in all animals.
- Gross pathology:
- Terminal necropsy revealed a discoloration of the tissue at application site, mottled kidneys and patchy lungs ( no visible lesions except signs of skin destruction and hemorrhage at application site).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the observations made in the Acute Dermal Toxicity Test in Rabbits, LD50 was 8300 mg/kg bw (95% confidence limits: 7300 - 9400 mg/kg bw).
- Executive summary:
In an acute dermal toxicity study performed according to OECD 402, but with deviations, an LD50 value of 8300 mg/kg bw was found.
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