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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-10-31 to 1994-11-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- December 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ceramide III
- IUPAC Name:
- Ceramide III
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Ceramide III
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 8-14 weeks
- Weight at study initiation: 2100 - 2604 g
- Housing: individual housing in labelled cages with perforated floors (Scanbur, Denmark) 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. In addition, hay (BMI Helmond, The Netherlands) was provided once a week.
- Water: ad libitum, tap-water diluted with decalcified water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod: fluorescent light (120 lux) 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 27 +-2 mg (a volume of approx. 0.1 ml)
- Concentration: undiluted - Duration of treatment / exposure:
- 24 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- After 24 hours (immediately after fluorescein examination) both eyes of one animal was rinsed with approx. 50 ml tepid tap water per eye, using a velocity of flow which did not affect the eyes, to remove residual test substance.
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1 h, 24 h, 48 h, 72 h after treatment. Besides the eyes were examined for potential eye lesions 24 h by means of 2 % fluorescein-dilution.
It was washed out with 50 ml tepid tap-water per eye, using a velocity of flow which did not affect the eyes, to remove residual test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- None described.
Any other information on results incl. tables
IRRITATION
Instillation of 27 mg (a volume of approx. 0.1 ml) into one eye of each of the animals resulted in effects in the iris and the conjunctivae.
The iridic irritation (grade 1) had resolved within 24 hours in all three animals. The irritation of the conjunctivae consisted of redness of the conjunctival tissues and had resolved within 24 hours in two animals and within 72 hours after instillation in the third animal. A small amount of discharge was also noted in the latter animal on day 1.
Remnants of the test substance were noted in the treated eyes on day 1 and/or 2.
CORROSION
There was no evidence of ocular corrosion.
COLOURATION
Remnants of the test substance were noted on the outside of the eyelids on day 1 and/or 2.
TOXIC SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
The individual scores of each of the three animals and the average score (24, 48, 72 h) are given in the table below.
|
CORNEA |
IRIS |
CONJUNCTIVAE |
CHEMOSIS |
Max. score |
4 |
2 |
3 |
4 |
Time point (h) |
||||
1 |
0/0/0 |
1/1/1 |
0/0/1 |
0/0/1 |
24 |
0/0/0 |
0/0/0 |
0/0/2 |
0/0/0 |
48 |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
72 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24, 48, 72 |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this in vivo study, the test item was not irritating to the rabbit eye and thus, no classification is required.
- Executive summary:
An acute eye irritation/corrosion study with Ceramide III in the rabbit was carried out in accordance with the OECD guideline No. 405, “Acute Eye Irritation/Corrosion” (February 24, 1987) and the EEC Directive 92/69 /EEC, B.5, “Acute Toxicity - Eye irritation” (December 1992).
Instillation of 27 mg of Ceramide III (a volume of approx. 0.1 ml) into an eye of each of three male New Zealand White albino rabbits resulted in effects on the iris and the conjunctivae in all animals. The untreated eye served as concurrent negative control. The irritation had resolved within 24 hours in two animals and within 72 hours after instillation in the third animal. The mean 24-72 h irritation score for all was 0.0 except for conjunctival redness (1.0) in one rabbit, which resolved completely after 72 h as described above.
No signs of systemic intoxication were observed during the study period.
In conclusion, Ceramide III was not irritating to the rabbit eye in this in vivo study.
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