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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- other: clear light yellow liquid
- 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
- Specific gravity: 0.89
- Sample preparation: The test article was used as received
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- 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: 2.4-2.7 kg for males and 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: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C) and humidity: controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The dorsal area of the trunk of each animal was prepared using a clipper. The test site was approximately 10% of the body surface. The test article was applied to the skin of the animal at a dose level of 2000 mg/kg. The dose was calculated based on the sample specific gravity. The test site was gentle covered with a 4 ply porous gauze dressing measuring 10x15 cm. The torso of the animal was wrapped with plastic in a semi-occlusive manner using a specific tape. The test material remained in contact with the skin for 24 hours. After 24 hour of exposure, the wrapping was removed by gentle washing with distilled water.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females and 5 males
- Details on study design:
- Toxicity and pharmacological effect were recorder after 1, 2 and 4 hours post dose and once daily for the remaining 14 days.
Mortality was recorded twice per day, except for day 10.
The bodyweight was recorded prior to testing, weekly and at termination.
The sacrifice of the animals was conducted using CO2, followed by gross pathology examination.
The test sites were scored at 24 hour, 7 and 14 day time points according to the numerical Draize scoring code. Observation included evidence of ulceration, necrosis and tissue damage. - Statistics:
- An estimation of the LD50 value was made based on the survival during the study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred during the study
- Mortality:
- No mortality occurred during the study
- Clinical signs:
- Instances of few feaces
- Body weight:
- The bodyweight changes were normal
- Gross pathology:
- Necropsy examination did not reveal any abnormities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for dermal toxicity of the test material Ceraphyl 55 is > 2000 mg/kg
- Executive summary:
The test material Ceraphyl 55 was tested on five male and five New Zealand White rabbits to evaluate the acute dermal toxicity.
The test article was applied onto the dorsal area of the trunk of each animal. The test material was applied to the skin of the animal at a dose level of 2000 mg/kg. The test site was gentle covered with a 4 ply porous gauze dressing measuring 10x15 cm and the torso of the animal was wrapped with plastic in a semi-occlusive manner. Dermal responses were recorded at 24 hours, 7 and 17 days after exposure. The animals were also observed for mortality, pharmacological effects and body weight changes. After sacrifice, a gross pathology examination was performed.
No mortality occurred during the study. The body weight values were in the normal range and the necropsy did not reveal any abnormalities. Instances of a few faeces were observed during the 14 day. The result of the study shows that the acute dermal toxicity LD50 of Ceraphyl 55 is >2000 mg/kg.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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