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EC number: 300-338-1 | CAS number: 93925-36-1
- 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, other
- Remarks:
- The in-vivo study is performed before in-vitro testing was preferably applied.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- EC Number:
- 300-338-1
- EC Name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- Cas Number:
- 93925-36-1
- Molecular formula:
- C3O2-C12/13/14/15
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- Reference substance name:
- Ceraphyl 41
- IUPAC Name:
- Ceraphyl 41
- Test material form:
- other: liquid
- Details on test material:
- Batch #5710
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- Every 24 hours for four days and on the seventh day.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 16
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Highest score of 3 at 24 h, 2 at 48-72h.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Highest score for redness of 2 at 24 - 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: day 7
- Score:
- 12
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Highest score for redness of 3 at 24 h and of 2 at 48, 72 and 96 h.
- Other effects:
- Not recorded.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Installation of 0.1 ml of the test material into the right eye of three rabbits produced a moderate irritation involving only the conjunctivae. On the seventh day of observation these eyes were normal showing full reversibility.
- Executive summary:
CERAPHYL® 41 was mildly irritating to the eyes of rabbits. Three albino rabbits received a single application of CERAPHYL® 41 (0.1 ml) into the conjunctival sac of one eye. The contralateral eye, remaining untreated, served as a control. The eyes were examined and scored for effects on the cornea, iris and conjunctiva on Days 1, 2, 3, 4 and 7 after treatment. No corneal opacity or iritis was observed. Conjunctival irritation, noted in all the eyes, cleared by Day 7.
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