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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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- 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:
- Seminal Cytology and Reproductive Toxicology of N-Chloropiperidine
- Author:
- Bempong MA, Scully FE
- Year:
- 1 983
- Bibliographic source:
- J. Am. Coll. Toxicol. 2, 209 - 219
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Mice were daily exposed to piperidine dissolved in ethanol for a period of 100 days and examined for induction of sperm abnormality and reproductive toxicity.
- GLP compliance:
- not specified
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
- no further data
Test animals
- Species:
- mouse
- Strain:
- other: C57BL/J6 x DBA2
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory Animal Division, Mogul Corporation, Madison, Wisconsin
- Age at study initiation: (P) 8 to 10 wks
- Weight at study initiation: (P) Males and Females: 20 to 26 g
- Diet: Purina Lab Chow, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- no data
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- ethanol
- Remarks:
- 0.001 % ethanol
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- piperidine was dissolved in ethanol
VEHICLE
- Concentration in vehicle: 400 mg/kg bw/day in 0.001 % ethanol - Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: 7 days
- Proof of pregnancy: vaginal plug
- After successful mating each pregnant female was caged (how): single - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: 100 days
Premating exposure period (males): 1 week
Premating exposure period (females): 1 week
Duration of test: 100 days - Frequency of treatment:
- daily exposure (ad libitum)
- Details on study schedule:
- The treatment groups consisted of (1) control female x control male (C x C); (2) piperidine-treated female x piperidine treated male (PD x PD).
Ethyl methanesulfonate (EMS) served as positive control.
In the study piperidine was used as negative control.
Doses / concentrations
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 15 to 25 females
- Control animals:
- other: aqueous solution containing 0.001 % ethanol ad libitum
- Details on study design:
- - Dose selection rationale: Concentrations between 600 and 800 mg/kg bw/day killed between 70 and 90% of exposed animals within 10 days.
- Positive control:
- Positive control animals were exposed to 250 mg/kg bw/day of ethylmethane sulfonate (EMS) prepared in deionized water.
Examinations
- Sperm parameters (parental animals):
- Sperm Morphology Study
- Preliminary investigation showed that significant levels of sperm damage are observed after about 40 continuous days of treatment; accordingly, on day 40 and every subsequent 5 days, treated and control animals (3 animals per group) were sacrificed and both left and right vas deferens removed by dissection. Sperm were squeezed into saline solution (0.9%) and slides prepared and stained in eosin-Y. - Litter observations:
- Fertility Studies
- Fifteen to 20 pregnant females were sacrificed by cervical dislocation on day 18 of pregnancy; the uteri were removed and examined for the site of implantation and foetal death. Five females in each treatment group were allowed to reach term and the number of offspring per female recorded. - Statistics:
- Chi square and t-test were used for comparison of fertility index, abnormal sperm morphology, moles per pregnancy, and foetal death per implant between the test compound and the control groups.
- Reproductive indices:
- Fertility index expressed as the ratio of the number of pregnant females to the number of females mated in a specified mating period.
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- The percentage of abnormal sperm was in the range of the vehicle control (determined at 40, 50, 60, 70, 80 and 90 days of treatment).
Details on results (P0)
The number of dead fetuses/pregnancy was also not influenced by 2 to 12 weeks of piperidine treatment.
Females which were allowed to deliver litter had with the exception of week 4 with 7 pubs/female, 8.5 - 10 pups/female after 1 to 3 and 4 to 10 weeks of piperidine treatment (weekly determination; vehicle control: 8.5 - 10 pups/female).
In the EMS-treated matings, reduced fertility indices were observed.
The number of dead fetuses/pregnancy was also influenced by 2 to 12 weeks of EMS treatment of about 0.8 to 1.4.
Females which were allowed to deliver litter had 6 pups/female after 1 to 10 weeks of EMS treatment (weekly determination; vehicle control:
8.5 - 10 pups/female).
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: corresponding to the highest dose tested
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive 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.