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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Synthetic flavors: efficiency and safety factors for sweaty and fishy odorants
- Author:
- Amoore JE, Gumbmann MR, Booth AN, Gould DH
- Year:
- 1 978
- Bibliographic source:
- Chem. Senses Flavour 3, 307 - 317
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Piperidine was administered to rats in a 90 day feeding study.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Piperidinium chloride
- EC Number:
- 228-033-8
- EC Name:
- Piperidinium chloride
- Cas Number:
- 6091-44-7
- Molecular formula:
- C5H11N.ClH
- IUPAC Name:
- piperidinium chloride
- Details on test material:
- TS-Freetext:
piperidine hydrochloride
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): piperidine hydrochloride
- Physical state: chrystalline
- Impurities (identity and concentrations): contains odorous impurities.
- Source: obtained as crystalline hydrochloride (Aldrich Chemical Company, Milwaukee, Wisconsin).
Test animals
- Species:
- rat
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 weeks
- Weight at study initiation: 90 g (tested in weight-matched groups of 5 or 6)
- Diet (e.g. ad libitum): diet composed of 30% dextrose, 20% cornmeal, 20% soybean meal, 10% casein, 9% corn starch, and 5% corn oil, with 4% salt mixture and 2% of a mixture of vitamins triturated in dextrose
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- After allowing for ca. 40% hydration of the piperidine sample, it was added to the diet in its crystalline state (base content 35 -45%, w/w). - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily, continuously in the diet
Doses / concentrationsopen allclose all
- Dose / conc.:
- 80 mg/kg bw/day (nominal)
- Remarks:
- corresponding to 0.08 % in the diet
- Dose / conc.:
- 160 mg/kg bw/day (nominal)
- Remarks:
- corresponding to 0.16 % in the diet
- Dose / conc.:
- 310 mg/kg bw/day (nominal)
- Remarks:
- corresponding to 0.31 % in the diet
- No. of animals per sex per dose:
- 5 - 6 males
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Initial 14-day trials were run to find the maximum concentration of additive that was compatible with normal food intake and weight gain. Having found the appropriate level, the feeding trial was continued to 90 days.
- Post-exposure recovery period in satellite groups: no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at 80 days
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked:
∙ counts of erythrocytes,
∙ leukocytes,
∙ hematocrit and
∙ hemoglobin.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 80 days
- Animals fasted: No data
- How many animals: No data
- Parameters checked: tests run on plasma from the rats:
∙ albumin,
∙ total protein,
∙ total bilirubin,
∙ urea nitrogen,
∙ glutamic-oxaloacetic transaminase,
∙ glutamic-pyruvic trans-aminase,
∙ alkaline phosphatase, and
∙ ornithine-carbamoyl transferase.
URINALYSIS: Yes
- Time schedule for collection of urine: at 70 days
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked:
∙ Urine was examined microscopically, and tested for
∙ pH,
∙ specific gravity,
∙ occult blood,
∙ ketones,
∙ glucose,
∙ protein,
∙ bilirubin and
∙ urobilinogen.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, at the end of the 90-day feeding trial, the rats were killed by exsanguination under ether anesthesia and necropsied.
- Organs were weighed
HISTOPATHOLOGY: Yes
- tissues were fixed in neutral phosphate-buffered 10% formalin, embedded in paraffin, sectioned at six microns, and stained with hematoxylin and eosin. Thirty-five tissues were subjected to routine histological examination.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Description (incidence and severity):
- no data
- Description (incidence and severity):
- - Growth, in grams per rat per day:
▫ after 14 days:
∙ 0.62 % dose group: -1.0 g/animal/day compared to the control: 6 g/animal/day; discontinued after 7 days;
∙ 0.31 % dose group: 1.9 g/animal/day compared to the control: 6 g/animal/day; significantly less growth than control rats without additive, p<0.05;
∙ 0.16 % dose group: 3.3 g/animal/day compared to the control: 6 g/animal/day; significantly less growth than control rats without additive, p<0.05;
∙ 0.08 % dose group: 5.2 g/animal/day compared to the control: 6 g/animal/day;
∙ 0.04 % dose group: 6.0 g/animal/day compared to the control: 6 g/animal/day;
▫ after additional 84 days:
∙ At the low dose group of 0.08 %: the growth was not influenced after the 90 days treatment. There were no significant differences in body weights between the 0.08 % dose group (5.2 g/animal/day) and the control (4.9 g/animal/day).
∙ In the mid- and high-dose group ( 0.16 %: 3.6 g/animal/day; 0.31 %: 2.5 g/animal/day) growth was significantly reduced in comparison to the control (4.9 g/animal/day). - Description (incidence and severity):
- - At 0.08 % test substance in the diet, the food consumption was not influenced. During the first 14 days of the feeding trial, the maximum concentration of the test item in the diet, that was not significantly incompatible with normal food consumption and growth, was 0.08%.
- Food efficiency:
- not specified
- Description (incidence and severity):
- no data
- Description (incidence and severity):
- - There were no significant differences in haematology between the 0.08 % dose group and the control.
- Description (incidence and severity):
- - There were no significant differences in plasma constituents between the 0.08 % dose group and the control.
- Description (incidence and severity):
- - There were no significant differences in urinalysis between the 0.08 % dose group and the control.
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- no data
- Description (incidence and severity):
- - There were no significant differences in organ weights between the 0.08 % dose group and the control.
- Description (incidence and severity):
- ▫ 0.08 % dose group:
- There were no significant differences in histological appearance compared to the control group.
▫ 0.31 % dose group:
- Significant alterations involving the seminal vesicles and prostate occurred in the rats receiving 0.31 % piperidine.
- The seminal vesicles were markedly reduced in size and weight, and had a reduced number of secretory granules.
- The prostate changes were less pronounced and consisted of tubular collapse and reduction in the amount of secretory materials.
- Other lesions present in these animals were uniformly distributed throughout all groups, and were of types commonly observed in animals of this age, sex, strain and origin.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 80 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- LOAEL
- Effect level:
- 160 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: At 160 mg/kg bw body weight gain is reduced.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.