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EC number: 812-962-6 | CAS number: 34354-88-6
- 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
- Study period:
- 1992-01-28 to 1992-01-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- September 1984
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-
- EC Number:
- 812-962-6
- Cas Number:
- 34354-88-6
- Molecular formula:
- C36H73NO4
- IUPAC Name:
- Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-
- Test material form:
- solid: particulate/powder
- Details on test material:
- Ceramide III
Constituent 1
- Specific details on test material used for the study:
- The test substance was determined not to be miscible with water and static.
The test substance was ground to a powder using a mortar and pestle.
To ensure close contact to the animal’s skin, the powdery test substance was applied using a patch, which was moistened with distilled water immediately before use.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Rabbit, New Zealand White, (SPF-Quality)
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 13 weeks
- Weight at study initiation: 2311-2833 grams
- Housing: conventionally, singly in stainless steel cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- diet: ad libitum, standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water: ad libitum, tap-water diluted with decalcified water
- Acclimation period: at least 5 days before start of treatment under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- no vehicle; test substance was applied using a moistened patch
NEGATIVE CONTROL
- The contralateral flank was similarly prepared, but without test substance
. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 50 min, 24 h, 48 h and 72 h after removal of the dressings and test substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: 100 %. Due to the physical properties of the test substance the amount of 0.5 g could not be dosed completely within the area that was covered by the patch (6 cm²) and a small amount was applied outside this area.
- Type of wrap if used: moistened Scotchpak-non-woven patch (2x3 cm, 3M, St. Paul, U.S.) mounted on Micropore tape (3M, St. Paul, U.S.). The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.)
REMOVAL OF TEST SUBSTANCE
- the remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: the test results were evaluated according to OECD guideline No. 404, “Acute Dermal Irritation/Corrosion”, adopted 28 July 2015.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1,#2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 50 min
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 50 min
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No other effects reported.
Any other information on results incl. tables
IRRITATION
No skin irritation was caused by the test substance after a 4 h dermal application.
CORROSION
There was no evidence of a corrosive effect on the skin.
COLOURATION
No staining of the treated skin by the test substance was observed.
TOXICITY SYMPTOMS, MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period. No mortality occurred.
Table: Irritant/corrosive response data at each observation time point (mean of all animals).
Score at time point / Reversibility | Erythema | Edema |
Max. score: 4 | Max. score: 4 | |
50 min | 0/0/0 | 0/0/0 |
24 h | 0/0/0 | 0/0/0 |
48 h | 0/0/0 | 0/0/0 |
72 h | 0/0/0 | 0/0/0 |
Average 24h, 48h, 72h | 0/0/0 | 0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance did not cause any irritation and thus, classification is not required.
- Executive summary:
In this skin irritation / corrosion study according to OECD Guideline No. 404 (May 12, 1981) and EEC Directive 84/449/EEC, Part B.4 (September 1984), 0.5 g of Ceramide III was applied onto shaved skin of three New Zealand White male albino rabbits using semi-occlusive dressings for 4 hours. An adjacent area of untreated skin, similarly prepared but without test substance and vehicle served as control area.
After 4 hours, Ceramide III was removed using tissue moistened with tap-water. Observations were made after 50 minutes, 24, 48, and 72 h after patch removal.
No reactions were seen; mean erythema and oedema scores after 24, 48, and 72 h were 0 in all animals.
Based on the results of this test, Ceramide III is not irritating to skin.
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