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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 812-963-1 | CAS number: 178436-06-1
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- Irritation potential on healthy human skin
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- unknown
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Type of study / information:
- Test to determine the irritation potential on healthy human skin.
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 0.01 g of the test sample was placed in a finn chamber (EPITEST Ltd. Oy.) and a 24-hour occlusive application on the flexor side of the subject's upper arm was conducted. After 24 hours the test sample was removed and the skin condition was examined, both 1 hour and 24 hours after removal.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ceramide IIIB
- IUPAC Name:
- Ceramide IIIB
- Test material form:
- liquid: viscous
- Details on test material:
- CERAMIDE IIIB (5% vaseline solution)
Constituent 1
- Specific details on test material used for the study:
- 5 % vaseline solution
Method
- Ethical approval:
- not specified
- Details on study design:
- Subjects: A total of 44 subjects, 19 males and 25 females with ages between 20 to 52.
Amount applied: 0.01 g - Details on exposure:
- 0.01 g of the test sample was placed in a finn chamber and a 24-hour occluxive application on the flexor side of the subject's upper arm was conducted. After 24 hours the test sample was removed and the skin condition was examined, both 1 hour and 24 hours after removal.
Results and discussion
- Results:
- The results of the patch test conducted on 44 subjects:
No reactions were observed 1 hour after the removal of the test sample. No reactions were observed
24 hours after removal of the test sample also.
No abnormalities were observed.
Applicant's summary and conclusion
- Conclusions:
- The results of the patch tests were negative in all cases; thus it is concluded that the test item does not cause skin irritation.
- Executive summary:
Patch tests were performed in 44 healthy humans to determine the irritation potential of Ceramide IIIB.
The results were negative in all cases; thus it is concluded that there is little possibility that Ceramide IIIB can cause irritation.
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.