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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005/01/12-2005/05/27
- 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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
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:
- 123-03-9
- IUPAC Name:
- 123-03-9
- 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 received: January 12, 2005
PSL Reference No: 050112-ID
Study Initiation Date: January 24, 2005
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or test system and environmental conditions:
- Housing: The animals were singly house in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature Range: 19-22C.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 21 Days
Food: Pelleted Pruina Rabbit Chow # 5326 ad libitum. Water supplied ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test material; (moistened with water, so 0.77g of the test mixture)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days.
- Number of animals:
- 3 rabbits
- Details on study design:
- Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 65% w/w mixture. Five-tenths of a gram of the test substance (0.77g of the test mixture) was placed on a 1 -inch by 1 -inch, 4 ply gauze pad and applied to one 6 -cm^2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 -inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their disignated cages.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 4.9
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Within 24 hours of patch removal, all three treated sites exhibited moderate to severe erythema and slight edema. Although the overall serverity of irritation gradually decreased, dermal irritation (erythema, edema, desquamation, and/or superficial eschar) persisted for all animals through Day 14.
- Other effects:
- No clinical signs or evidence of systemic toxicity.
Any other information on results incl. tables
Moderately irritating.
(PDII): PDIfor1, 24, 48 and 72 hours= 4·9
4
|
Hours |
Days |
|||||
1 |
24 |
48 |
72 |
7 |
10 |
14 |
|
Erythema |
3.0 |
3.0 |
3.0 |
3.0 |
3.0 |
2.3 |
1.7 |
Edema |
1.7 |
2.0 |
2.0 |
2.0 |
2.0 |
1.3 |
1.3 |
TOTAL(PDI)2 |
4.7 |
5.0 |
5.0 |
5.0 |
5.0 |
3.6 |
3.0 |
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CPC is classified as moderately irritating to the skin, with a PDII of 4.9.
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