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Diss Factsheets
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EC number: 203-813-0 | CAS number: 110-89-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Version / remarks:
- 1989
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study has been conducted before the implementation of the LLNA method.
Test material
- Reference substance name:
- Piperidine
- EC Number:
- 203-813-0
- EC Name:
- Piperidine
- Cas Number:
- 110-89-4
- Molecular formula:
- C5H11N
- IUPAC Name:
- piperidine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Piperidine
- Physical state: Liquid, Colorless
- Lot/batch No.: 20221AA
- Storage condition of test material: Room Temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm HilI Breeding Labs, Chelmsford, MA, U.S.
- Age at study initiation: 21-43 days
- Weight at study initiation: 250 - 400 grams
- Housing: group housed in stainless steel cages
- Diet: diet of commercial guinea pig ration (Agway Prolab, Agway, Waverly, NY); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 6 days (Preliminary Irritation Study) and 9 days (Sensitization Study)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10 to 13
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- No. of animals per dose:
- 28
- Details on study design:
- RANGE FINDING TESTS:
The Preliminary Irritation Study
- Number of animals: 4 previously unexposed animals. This phase was run before the start of the challenge phase.
- Site: Before each application of the test or control substance the animals were clipped and shaved on the left shoulder, in an area of about 3 x 4 cm.
- Amount: 0.4 ml
- Method: Closed patches for the experimental group were prepared as folIows: Test substance was applied directly to the skin and covered with a gauze pad. The patch was applied to the prepared skin sites as soon as possible and kept in place with occlusive bandaging. At the end of the exposure the patch was removed and any residual test substance was washed off with water.
- Concentrations: 100 %, 50 %, 25 % and 10 %.
- Exposure period: 6 hours
- Scoring system: Draize Scoring
- Readings: 24 hour after the test substance application and up to 72 hours the highest nonirritant and minimal irritant concentrations were determined.
- The test substance was found to be moderately to strongly irritating at concentrations of 100 % (necrosis) and 50 % (Erythema Grade 2.0 to 3.0) and non-irritating at a concentration of 25 % in the Preliminary Irritation Study. Therefore, the 25% concentration was considered the minimally irritating concentration and the maximal nonirritating concentration and applied at both the induction and challenge phases.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: 25 % test substance
- Control group: Negative Control: water; Positive Control: Dinitrochlorobenzene
- Site: Before each application of the test or control substance the animals were clipped and shaved on the left shoulder, in an area of about 3 x 4 cm.
- Method: closed patch technique (see above)
- No. of exposures and frequency of applications: The test substance was applied once per week for 3 consecutive weeks (week 01, 02, 03) on one side of the animal. The positive control substance was applied in the same manner.
- Duration: 3 weeks
- Concentrations: 25 % (0.4 ml)
- Reading: Induction scoring was performed 24 hours after the test substance application.
B. CHALLENGE EXPOSURE
- No. of exposure: one
- Day(s) of challenge: During week 05, the challenge test was performed on freshly clipped skin sites in the same way as the 6 hour closed patch test of the induction phase.
- Exposure period: The skin was exposed to the test substance for 24 hours.
- Site: The day preceding the challenge, a 4 x 3 cm virgin skin site was shaved on the backs of the experimental and control animals.
- Evaluation (hr after challenge): At 24 hours after application of the challenge dose, the area of the challenge was marked and the whole back shaved. Two hours after shaving, the test site was examined for erythema and edema. The reaction was graded as follows:
0.0 = No reaction
0.5 = Very faint erythema, usually confluent
1.0 = Faint erythema, usually confluent
2.0 = Moderate erythema
3.0 = Strong erythema with or without edema
Reading of the skin area was repeated 48 hours after the challenge and the skin reactions were graded.
- Rechallenge
It was not considered necessary to rechallenge the sensitized guinea pigs at 1 and 2 weeks after the primary challenge (weeks 06 and 07).
OTHER:
The results were summarized and expressed in the following terms:
Incidence - The number of animals showing a response of 1 or more, at 24 or 48 hours, divided by the number of test animals.
Severity - The sum of the test grades divided by the number of animals tested.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity and irritation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity and irritation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05 %
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Mean erythema and edema score of 2.25
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05 %
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Mean erythema and edema score of 2.75
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity and irritation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity and irritation
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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