Registration Dossier
Registration Dossier
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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
Eye irritation
Administrative data
- Endpoint:
- eye 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Ceraphyl 55
- Date received: 01/28/04
- Physical state: Clear light yellow liquid
- Lot/batch No.: P#1743
- Storage condition of test material: Room temperature and humidity
- Sample preparation: The test article was used as received
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Date of birth: 11/02/03
- Data received: 01/21/04
- Weight at study initiation: 2.8-3.1
- Housing: The animals were housed 1/cage in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321)was provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature and humidity: Controlled
- Humidity (%):
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24 48 72 hours post dose
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Prior to start the test, rabbits were checked for ocular irritation and corneal abnormalities. A 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The lids of the eye were hold together for approximately one second to prevent test material loss. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique.
At the end of the study, animals were sacrificed using CO2.
Bodyweights were recorded before the test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 110
- Irritant / corrosive response data:
- No corneal opacity or iritis. Conjunctival irritation was noted in 3/3 eyes. Effects were still evident in 2/3 animals at 24 hrs but had resolved by 48 hrs.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- The test material Ceraphyl 55 is considered to be minimally irritant under the condition of this study, so the level and frequency of the effects did not meet the criteria for classification as eye irritation.
- Executive summary:
The test material Ceraphyl 55 was tested in 3 New Zealand White rabbits. A 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique. The results show no evidence of corneal opacity or iritis. A conjunctival irritation was noted in 3/3 animals 1 hr after treatment. Effects were still evident in 2/3 animals at 24 hrs but were fully reversible within 48 hours. In conclusion, Ceraphyl 55 is considered to be a minimal irritant, but not corrosive, under the condition of this study.
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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