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EC number: 204-593-9 | CAS number: 123-03-5
- 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:
- toxicity to reproduction
- Remarks:
- other: repeated dose toxicity study in rats (atttention to reproductive organs)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline repeated dose toxicity study, according to GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 452 (chronic toxicity studies)
- Principles of method if other than guideline:
- 6 month repeated dose toxicity study with examination of reproductive organs
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Cetylpyridinium chloride
- EC Number:
- 204-593-9
- EC Name:
- Cetylpyridinium chloride
- Cas Number:
- 123-03-5
- Molecular formula:
- C21H38N.Cl
- IUPAC Name:
- cetylpyridinium chloride
- Reference substance name:
- CPC
- IUPAC Name:
- CPC
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- see 7.5.1: oral Minnema 1995
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Oral gavage of dose formulations prepared weekly. Amounts administered were adjusted weekly according to body weights.
- Details on mating procedure:
- No mating
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- RP-HPLC verification of dose concentrations and stability of formulations.
- Duration of treatment / exposure:
- 6 months
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 15, 40 and 75 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Includes ophthalmalogic examinatioon, and hematology, clinical chemistry and urinalysis.
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- Twice daily clinical observations; weekly physical examination and weighing. At necropsy, ophthalmologic examination, and full histological examination of all organ systems.
- Oestrous cyclicity (parental animals):
- not specifically examined
- Sperm parameters (parental animals):
- not specifically examined
- Litter observations:
- not applicable
- Postmortem examinations (parental animals):
- yes, see 7.5.1: oral. Minnema 1995.
Organs were weighed after trimming of fat and other continguous tissue: adrenals, brain, heart, kidneys, liver, ovaries, pituitary, spleen, stomach, testes with epididymides, thymus, thyroid/parathyroids.
GROSS PATHOLOGY: Yes; all animals
HISTOPATHOLOGY: Yes, on groups 1 and 4 (control and 75 mg/kg/d) and any gross lesions from animals in any group. Tissues preserved in 10% netural buffered formalin were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically.
Tissues preserved were: adrenals, aorta, brain, colon with cecum and rectum, duodenum, jejunum and ileum, esophagus, exorbital lacrimal glands, eyes, femur, heart, kidneys, liver, lung, mammary gland, mesenteric lymph node, ovaries, pancreas, pituitary, prostate, salivary glands, sciatic nerve, seminal vesicles, skin, spleen, sternum with bone marrow, stomach, spinal cord, testes with epididymides, thigh musculature, thyroid/parathyroids, thymus, trachea, urinary bladder, uterus with vagina and cervix. - Postmortem examinations (offspring):
- not applicable
- Statistics:
- yes, see 7.5.1: oral. Minnema 1995
- Reproductive indices:
- not applicable
- Offspring viability indices:
- not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1 unexplained death at 75 mg/kg/d
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- significant decreases in body weight or body wight gain at 40 and 75 mg/kg
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- significant decreases in body weight or body wight gain at 40 and 75 mg/kg
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- inflammation and necrosis of the stomach
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance intake: by gavage
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Local irritation (with necrosis and hyperplasia) of the stomach occurred at higher doses. No systemic toxicity observed.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The effects of oral gavage dosing of CPC were studied in a repeated dose protocol for 6 months in rats at doses of 5 to 75 mg/kg bw/d. Reproductive organs were excised, weighed and examined histologically for adverse effects. The major finding was localized gastrointestinal irritation observed at dose levels of 15 mg/kg/d and higher. Symptoms included salivation at dosing, soft feces, decreased food consumption, decreased body weight, thickened appearance of the non-glandular stomach, increased stomach weight, hyperplasia/necrosis/erosion/edema of the stomach. There was no histologic evidence of toxicity in any other organ examined, including reproductive organs. The material was not systemically toxic. The NOAEL for CPC based on the finding of stomach irritation is 5 mg/kg bw/d.
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