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EC number: 917-270-9 | CAS number: 29790-50-9
- 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:
- 29 january 2002 - 05 february 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD TG 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 439-210-6
- EC Name:
- -
- Cas Number:
- 554-62-1
- Molecular formula:
- C18H39NO3
- IUPAC Name:
- (2S,3S,4R)-2-aminooctadecane-1,3,4-triol
- Test material form:
- solid: particulate/powder
- Details on test material:
- SOURCE OF TEST MATERIAL
- Purity: 94.0 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark.
Constituent 1
- Specific details on test material used for the study:
- Batch: 62630012
Expiry date: 01 November 2002
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino rabbit (SPF-Quality)
- Details on test animals or test system and environmental conditions:
- Test animals
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Animals used within the study were at least 6 weeks old
- Weight at study initiation: weights were between 1.0 and 3.5 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 53.5x63x38.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits,Altromin, Germany) approx. 100 g per day
- Water: Free access to tap-water
Environmental conditions
- A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21±3°C, a relative humidity of 30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Ethanol
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Concentration applied: Each animal was treated by dermal application of 0.5 grams of the test substance.
- Vehicle: Since the test substance did not mix with water, the powdery test substance was moistened with watery ethanol (50% v/v), immediately before application, to ensure close contact with the animal's skin. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours and 7 days after exposure
- Number of animals:
- 3
- Details on study design:
- Treament
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm^2). Whenever considered necessary, the treated skin areas were re-clipped at least 3 hours before the observations to facilitate scoring.
- A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
- Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.7 ml of the vehicle and applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.
Obervation
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body Weight: Day of treatment (prior to application)
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls
The irritation was assessed according to a numerical scoring system (according to guideline).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 123
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 124
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 125
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 123
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 124
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 125
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Irritation
Four hours exposure to 0.5 g of PHYTOSPHINGOSINE resulted in very slight to well-defined erythema and very slight to slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Scaliness was noted 7 days after the removal of the dressings and test substance.
Corrosion
There was no evidence of a corrosive effect on the skin. - Other effects:
- Colouration
No staining of the treated skin by the test substance was observed.
Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table1. Individual skin Irritation scores.
Animal# | 123 | 124 | 125 | |||||||
Time after exposure | Erythema | Oedema | comments | Erythema | Oedema | comments | Erythema | Oedema | comments | |
1hour | 2 | 1 | - | 2 | 2 | - | 2 | 2 | - | |
24hour | 2 | 1 | - | 2 | 1 | - | 2 | 1 | - | |
48hour | 2 | 1 | - | 2 | 1 | - | 2 | 1 | - |
|
72hour | 1 | 0 | - | 2 | 1 | - | 1 | 1 | - | |
7days | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 |
Table2. Mean value Irritaion scores.
Animal# | Mean 24-72hrs | |||||
Erythema | Oedema | |||||
123 | 1.7 | 0.7 | ||||
124 | 2.0 | 1.0 | ||||
125 | 1.7 | 1.0 |
Table3. Animal Specifications
Animal# | Mean 24-72hrs | ||||||||
Sex | Age(weeks) | Body weight(grams) | |||||||
123 | male | 7-9 | 1421 | ||||||
124 | male | 7-9 | 1651 | ||||||
125 | male | 7-9 | 1493 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- acc. to CLP Regulation
- Conclusions:
- The test item phytosphingosine is slightly irritating to skin. Skin irritation resolved within 7 days after exposure in all animals. There was no evidence of a corrosive effect on the skin.
- Executive summary:
Primary skin irritation/corrosion of phytosphingosine was investigated in rabbit (4 -hour semiocclusive application) and carried out according to OECD 404 and in compliance with GLP.
Four hours exposure to 0.5 g of phytosphingosine resulted in very slight to well-defined erythema and very slight to slight oedema in treated skin-areas of three rabbits. Skin irritation had resolved within 7 days after exposure in all animals. Moreover, there was no evidence of a corrosive effect on the skin. In conclusion, phytosphingosine is slighlty irritating to skin.
The study was considered reliable and adequate for hazard assessment of human health.
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