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Diss Factsheets
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EC number: 200-311-3 | CAS number: 57-09-0
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with no data on GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics
- Deviations:
- yes
- Remarks:
- Testing performed on three rabbits and for three preparations
- Principles of method if other than guideline:
- The method used for testing primary skin irritation was described by J.H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics", The Association of Food and Drug Officials of the United States, 1975 (pp. 46-48).
- GLP compliance:
- no
Test material
- Reference substance name:
- Cetrimonium bromide
- EC Number:
- 200-311-3
- EC Name:
- Cetrimonium bromide
- Cas Number:
- 57-09-0
- Molecular formula:
- C19H42N.Br
- IUPAC Name:
- cetrimonium bromide
- Reference substance name:
- Cetrimide C16, Batch no. 8787
- IUPAC Name:
- Cetrimide C16, Batch no. 8787
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- A white powder.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: SPF-Russian strain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzuchtanstalt WIGA, D-8741 Sulzfeld
- Weight at study initiation: 1600-1750 G
- Housing: Single cages, 45x90 cm with a floor of wire netting
- Diet: free access to feed pellets (green rabbit KFK 7112)
- Water: free access to fresh water
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2
- Humidity (%): 50±10
Test system
- Type of coverage:
- other: 2 layers of gauze, rabbits hereafter wrapped in a plastic-coated cellulose material fastened by tape
- Preparation of test site:
- other: clipped, half of test sites were scratched by a 18G needle
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g to each test field
- Concentration (if solution): 0.1, 0.5 and 2.5 % (w/w) - Duration of treatment / exposure:
- 24 hours, treated skin was washed with water and left uncovered 48 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 9
- Details on study design:
- TEST SITE
- Area of exposure: 10x15 cm, divided into six fields (25 cm2 each)
- Type of wrap if used: 2 layers of gauze, rabbits hereafter wrapped in a plastic-coated cellulose material fastened by tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, after 24 hours of exposure
- Time after start of exposure: 24 hours
SCORING SYSTEM: Erythema and eschar; oedema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.1%
- Irritation parameter:
- erythema score
- Basis:
- animal: #4, #5, #6
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.5%
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- erythema score
- Basis:
- animal: #9
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.1%
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #3
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.1%
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 72 hours
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Scratched, 0.5%
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Scratched, 0.5%
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.5%
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- other: 72 hours
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- erythema score
- Basis:
- animal: #8, #9
- Time point:
- other: 72 hours
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.1%
- Irritation parameter:
- edema score
- Basis:
- animal: #4, #5, #6
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 0.5%
- Irritation parameter:
- edema score
- Basis:
- animal: #7, #8, #9
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- other: 72 hours
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
- Irritation parameter:
- edema score
- Basis:
- animal: #9
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and scratched, 2.5%
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin irritant effect of the test substance is investigated at different concentrations on nine albino male rabbits. Accordingly, at 0.1% (w/w) the substance was not a skin irritant, at 0.5% (w/w) the substance was non to mildly irritant, and at 2.5% (w/w) the susbtance was a moderate irritant giving a response complying with the CLP criteria for classification as Skin Irrit. 2.
The corresponding dermal loads were 20 µg/cm2, 100 µg/cm2 and 500 µg/cm2. - Executive summary:
The skin irritant effect of the test substance is investigated at different concentrations on nine albino male rabbits. Accordingly, at 0.1% (w/w) the substance was not a skin irritant, at 0.5% (w/w) the substance was non to mildly irritant, and at 2.5% (w/w) the substance was a moderate irritant almost complying with the CLP criteria for classification as Skin Irrit. 2. A specific concentration limit for classification of 2.5% would be appropriate.
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.
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