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EC number: 810-472-7 | CAS number: 159325-45-8
- 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:
- 3 - 17 November 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 928-664-5
- EC Number:
- 928-664-5
- IUPAC Name:
- 928-664-5
- Reference substance name:
- (1S,2S,4R,6S,8S,11R,12S,14S,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-one
- Cas Number:
- 159325-45-8
- Molecular formula:
- C23H35NO2
- IUPAC Name:
- (1S,2S,4R,6S,8S,11R,12S,14S,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Epyrron
- Physical state: Off white powder
- Composition of test material, percentage of components: Main component 55%; Other 22% and 18%
- Lot/batch No.: GV-1458 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 6 weeks
- Weight at study initiation: 3.5 kg
- Housing: Individual cages with perforated floors
- Diet: 100 grams per day of standard laboratory rabbit diet (LKK-20, pellet, Hope Farms, Woerden, The Netherlands)
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 48.6 g (approximately 0.1 mL) - Duration of treatment / exposure:
- Single samples were instilled. Remnants of the test substance were present in the eyes of all rabbits up to 48-72 hours after installation.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50 mL of tap-water
- Time after start of exposure: 48 hours
SCORING SYSTEM:
See free text section below
TOOL USED TO ASSESS SCORE: 2% fluorescein in water for 24 hour observation of corneal epithelial damage.
All other examinations were completed using standard lighting or with the assistance of an ophthalmic examination lamp.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Effects of irritation were observed within cornea, iris and conjunctivae.
Corneal injury consisted of opacity and epithelial damage (25-35% of corneal area).
Iridic irritation was observed in all rabbits exposed to test substance.
Irritation of conjunctivae consisted of redness, chemosis and discharge in all animals exposed to test substance.
There was no evidence of corrosion. - Other effects:
- Remnants of the test substance were present in the eyes of all animals up to 48-72 hours after exposure.
No symptoms of toxicity were observed during test period, no mortality occurred.
Any other information on results incl. tables
Individual Eye Irritation Scores | |||||||
Animal No. | 1453 | 1479 | 1485 | ||||
Time after dosing | Tissue Findings | Score | Comments | Score | Comments | Score | Comments |
1 hour | Corneal opacity | 0 | D | 0 | D | 0 | D |
area | 0 | 0 | 0 | ||||
Iris | 1 | 1 | 1 | ||||
Conj.: redness | 2(A) | 2(A) | 2(A) | ||||
Chemosis | 3(A) | 3(A) | 3(A) | ||||
Discharge | 2 | 2 | 2 | ||||
24 Hours | Corneal opacity | 0 | 25 D | 0 | 35 D | 0 | 25 D |
area | 1 | 2 | 1 | ||||
Iris | 0 | 1 | 1 | ||||
Conj.: redness | 3(A) | 3(A) | 3(A) | ||||
Chemosis | 2(A) | 2(ABC) | 2(ABC) | ||||
Discharge | 1 | 2 | 2 | ||||
48 Hours | Corneal opacity | 1 | D | 1 | D | 1 | D |
area | 1 | 2 | 1 | ||||
Iris | 0 | 1 | 0 | ||||
Conj.: redness | 3(AC) | 3(AC) | 3(AC) | ||||
Chemosis | 1(ABC) | 2(A) | 2(A) | ||||
Discharge | 1 | 1 | 1 | ||||
72 Hours | Corneal opacity | 0 | 5 | 0 | 25 D | 0 | 5 D |
area | 1 | 2 | 1 | ||||
Iris | 0 | 0 | 0 | ||||
Conj.: redness | 2(AC) | 2(AC) | 3(C) | ||||
Chemosis | 1(AC) | 1(AC) | 1(ABC) | ||||
Discharge | 0 | 1 | 1 | ||||
7 Days | Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0 |
area | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | ||||
Conj.: redness | 0 | 1(AC) | 1(C) | ||||
Chemosis | 0 | 0 | 0 | ||||
Discharge | 0 | 0 | 0 | ||||
14 Days | Corneal opacity | 0 | 0 | 0 | |||
area | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | ||||
Conj.: redness | 0 | 0 | 0 | ||||
Chemosis | 0 | 0 | 0 | ||||
Discharge | 0 | 0 | 0 | ||||
() Score given for: A=Eyelids | |||||||
B=Nictitating membrane | |||||||
C=Sclera | |||||||
Comments | |||||||
D - Remnants of the test substance in the eye |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was administered to 3 male rabbits and appears to be irritating to the eye at a dosage of 0.5 grams.
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