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Diss Factsheets
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EC number: 458-930-1 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Ceraphyl 55
- Supplied by: International Specialty Products
- Data received: 01/28/04
- Storage: Room temperature and humidity
- Description: Clear light yellow liquid
- Sample preparation: The test article was used as received
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Supplied on: 02/04/04
- Date of birth: 11/09/03 and 11/16/03
- Weight at study initiation: 2.5-2.7 for females
- Housing: Suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Free available
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C) and humidity: controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml/site
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 1 male and 2 females rabbits
- Details on study design:
- The dorsal area of the trunk of each animal was clipped free of hair. The test site was approximately 10x10 cm.
The day after the preparation, 0.5 ml/site of the test article was applied under a 2.5x2.5 cm, 4 ply surgical gauze patches. The patch was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. A layer of extra tape covered the plastic in order to prevent displacement and possible evaporation of the test article.
The test material stayed in contact with the skin of the animals for 4 hours at which time, the wrapping was gently removed and the skin was gentle washed with distilled water.
The test sites were scored for dermal irritation at 60 minute, 24, 48 and 72 hour time points. Erythema and edema were scored according to the numerical Draize score. Any areas of ulcerations, necrosis and tissue damage was also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 60 minutes
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: No mortaly occurred
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No mortality occurred
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2
- Time point:
- other: 60 minutes
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: No mortality occurred
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 60 minutes
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No mortality occurred
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No mortality occurred
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article Ceraphyl 55 is not irritating under test conditions.
- Executive summary:
The test material Ceraphyl 55 was tested on 1 male and 2 female New Zealand White rabbits. A volume of 0.5 ml of the test article was applied to a patch and placed to the dorsal area of the trunk of each animal. The test site was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. The test material stayed in contact with the skin of the animals for 4 hours. The skin treated was scored for erythema and edema at 60 minute, 24, 48 and 72 hour time points according to the numerical Draize score. Any evidence of ulcerations, necrosis and tissue damage was also recorded. The result of the test shows erythema and edema score of 1 in 2 and 3 animals respectively at 60 minute time point. The dermal irritation was fully reversible within 24 hours. At 24, 48, 72 hour time points, the erythema and edema scores were 0 in all animals. In conclusion, the test material Ceraphyl 55 is considered to be not irritant under the condition of this test.
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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