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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2004-May 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
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
- Details on test material:
- Test Substance Identification: Cetylpyridinium Chloride
Lot #00217966
Purity: 100.1% by assay
Test Substance Description: White Powder
Date Recieved: January 12, 2005
PSL Reference No.: 050112-ID
Study Initiation Date: January 24, 2005
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Number of Animals: 36
Number of Groups: 3
Sex: Male and Female
Species/Strain: Guinea pigs/Hartley Albino
Housing: Aniamls were housed in suspended stainless steel caging with mesh floors or plastic perforated bottom caging. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature Range: 19-23 Degrees C.
Photoperiod: 12-hour light/dark cycle
Food: Pelleted Purina Guinea Pig Chow #5025
Water: Filtered tap water
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction Phase: Once each week for three weeks, four-tenths of a milliliter of a 5% w/w mixture of the test substance was applied
Challenge Phase: Twenty-seven days after the first induction dose, four-tenths of a milliliter of a 0.1% w/w mixture of the test stubstance was applied
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction Phase: Once each week for three weeks, four-tenths of a milliliter of a 5% w/w mixture of the test substance was applied
Challenge Phase: Twenty-seven days after the first induction dose, four-tenths of a milliliter of a 0.1% w/w mixture of the test stubstance was applied
- No. of animals per dose:
- Number of Animals: 36
Preliminary Irritation Group: 6
Test Group: 20
Naive Control Group: 10 - Details on study design:
- The fur of a group of animals was removed by clipping the dorsal area and flanks 24 hours before testing. Once each week for three weeks, 0.4 ml of a 5% w/w mixture of the test substance in distilled water was applied to the left side of each test animal using an occlusive 25 mm Hill Top Chamber. The chambers were secured in place and wrapped with non-allergenic Durapore adhesive tape. After the 6-h exposure period, the chambers were removed and the test sites were gently cleansed of any residual test substance. Approximately 24 and 48 hours after each induction application, readings were made of local reactions (erythema) according to the scoring system described. Twenty-seven days after the first induction dose, 0.4 ml of a 0.1% w/w mixture of the test substance in distilled water (HNIC) was applied to a naive site on the right side of each animal as a challenge dose, using the procedures described above. These sites were evaluated for a sensitization response (erythema) approximately 24 and 48 hours after the challenge application according to the system described.
In addition to the test animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with the HNIC of the test substance at challenge only. These animals constituted the "naive control" group. - Positive control substance(s):
- yes
- Remarks:
- HCA
Results and discussion
- Positive control results:
- alpha-Hexylcinnamaldehyde Technical (HCA) as a positive control substance. The most recent validation, PSL Study #16901, was performed by Product Safety Laboratories and testing was completed on March 4, 2005.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: naive group
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: very faint erythema (score 0.5).
Any other information on results incl. tables
No skin reactions occurred in the test group that were more severe than that observed in the naive group, indicating the substance shows minor skin irritation. The conclusion is that CPC is not sensitising.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these findings and on the evaluation system used, Cetylpyridinium Chloride is not considered to be a contact sensitizer.
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