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EC number: 203-808-3 | CAS number: 110-85-0
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
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)
- Principles of method if other than guideline:
- OECD guideline 402: at least 5 animals of the same sex per dose group. In this study 4 animals (2 males, 2 females) were used per dose group.
OECD guideline 402: 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:
- standard acute method
- 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
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4236-42-15
- Physical state: light yellow liquld
- Analytical purity: no data
- 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
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 (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): fresh tap water, fit for human consumption, ad libitum,
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h 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: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 g/kg, 7, 9 and 10 g/kg - Duration of exposure:
- 24h
- Doses:
- Single dose: 8000 mg/kg;
LD50 doses: 7000, 9000 and 10000 mg/kg - 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:
- In the preliminary study using 10 animals and dosing at 8000 mg/kg bw of the test material 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:
- 7000 mg/kg : 1/4 animal died
9000 mg/kg : 2/4 animals died
(8000 mg/kg: 3/10 animals died)
10000 mg/kg : 4/4 animals died - Clinical signs:
- other: -cyanosis, diarrhea, salivation, mild convulsions, bleeding from mouth and nose, ataxia, loss of righting, abnormal stance, catatonia, ptosis, and decreased activity -necropsy of dying animals on study revealed black skin discoloration at application site
- 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:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the Acute Dermal Toxicity Test in rabbits, the LD 50 was 8300 mg/kg bw with 95% confidence limits of 7300 to 9400 mg/kg.
- Executive summary:
In an acute dermal toxicity study performed according to OECD 402, but with deviations in number of animals used and abrasion of the skin, an LD50 value of 8300 mg/kg was established.
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