Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
The skin and eye irritation/corrosion potential of Ceraphyl 55 was investigated. The skin irritation studies did not show any adverse effect, while the eye irritation studies showed a mild irritation activity, but not corrosion.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
- 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 - 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. - 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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 - 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. - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Four studies are available on skin and eye irritation/corrosion.
In a primary dermal irritation study (Consumer Product Testing, 1985) six young adult New Zealand white rabbits were exposed to 0.5 g of Ceraphyl 55 for 24 hours under occluded contact to intact skin. After 24 hours of exposure the wrapping material was removed and the skin was gently wiped. Animals were then observed and scored after 24 and 72 hours post-treatment. Edema and erythema were scored. Based on the findings of this study, the test material Ceraphyl 55 was not considered to be a skin irritant to rabbits.
A second study conducted by MB Research Laboratories (2004) performed an acute dermal irritation test following the OECD 404, under GLP conditions. 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. Evidence of any ulcerations, necrosis and tissue damage was also recorded. The result of test showed erythema and edema scores of 1 in 2 and 3 animals respectively at the 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.
In addition, a primary ocular irritation test was conducted by Consumenr Product Testing (1985) .The test material Ceraphyl 55 was investigated for eye irritation potential in 9 rabbits. A dose of 0.1 ml of the test article was placed in one eye of each animal selected for the test. The lower lid of the eye was gently pulled away from the eye ball to form a cup into which the test article was dropped. The contralateral eye remained untreated and served as control. The eyes of 6 rabbits remained unwashed for 24 hours. After that, the eyes were observed, scored and gently washed. The eye of the other three rabbits, were irrigated for 4 seconds following instillation of the test article with sufficient lukewarm water at room temperature to wash out all visible test article. Observations were made at 24, 48, 72 hours after treatment with the test material. Effects were limited to the conjunctiva and were fully reversible within 72 hours after treatment. Minimal irritation was observed after 24 hrs only, after the wash procedure.
The last study available was performed by MB Research Laboratories (2004).
The test material Ceraphyl 55 was tested in 3 New Zealand White rabbits. A concentration of 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. Mild conjunctival irritation was noted in 3/3 eyes 1 hr after treatment but was fully reversible within 48 hours. In conclusion, Ceraphyl 55 is considered to a be miminally irritant, but not corrosive, under the condition of this study.
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Data for skin irritation/corrosion shows that exposure to Ceraphyl 55 will likely not cause classification of the category. Based on the data available, Ceraphyl 55 is not required to be classified under the EU CLP Regulation (EC No. 1272/2008) and subsequent amendments thereof, for skin and eye irritation/corrosion.
Results from eye irritation studies show minimal eye irritation and no corrosion, so the level and frequency of the effects did not meet the criteria for classification as an eye irritant under the EU CLP Regulation (EC No. 1272/2008).
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.