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Diss Factsheets
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EC number: 601-595-5 | CAS number: 119302-20-4
- 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:
- 6 September to 5 November 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- (3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol
- EC Number:
- 601-595-5
- Cas Number:
- 119302-20-4
- Molecular formula:
- C27H46N2O3
- IUPAC Name:
- (3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): Pymordiol
- Physical state: Cream white solid
- Purity of test material: 96% wt%
- Expiration date of the lot/batch: 1 January 2001
- Stability under test conditions: Stable under test conditions
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks of age
- Weight at study initiation: 3.5 kg
- Housing: Individually cages with perforated floors
- Diet: 100 g per day of Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Hay was provided once per week (BMI, Helmond, the Netherlands).
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21˚C
- Humidity (%): 50%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/ 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 54.6 mg +/- 0.4 mg (volume of approx. 0.1 mL) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 Animals of one sex
- Details on study design:
- SCORING SYSTEM: See Tables No. 1 - 5 below
TOOL USED TO ASSESS SCORE: Fluorescein, and the use of ophthalmic examination lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Iridial irritation was reported in all animals on day 1 and was resolved within 24 hours.
Irritation of the conjunctivae was seen as redness, chemosis and discharge, which was completely resolved within 48 hours in one animal and 72 hours in the other test animals.
No corneal opacity was reported.
See tables No. 6 - 7 below for details on individual test animals and mean scores. - Other effects:
- No symptoms of systemic toxicity was observed in the animals during the test period and no mortality was observed.
Any other information on results incl. tables
Table 6: Individual Eye Irritation Scores
Animal No. | 469 | 470 | 471 | ||||||||
Time After Dosing | Tissue/Finding | Score | Fluor. Area (%) | Comments | Score | Fluor. Area (%) | Comments | Score | Fluor. Area (%) | Comments | |
1 hour | Corneal | Opacity | 0 | Remnants of test substance in the eye | 0 | Remnants of test substance in the eye | 0 | Remnants of test substance in the eye | |||
Area | 0 | 0 | 0 | ||||||||
Iris | 1 | 1 | 1 | ||||||||
Conj | Redness | 1 (ABC) | 2 (C) | 2(C) | |||||||
Chemosis | 1 (B) | 1 (ABC) | 2(C) | ||||||||
Discharge | 1 | 1 | 1 | ||||||||
24 hours | Corneal | Opacity | 0 | 0 | 0 | 0 | |||||
Area | 0 | 0 | 0 | ||||||||
Iris | 0 | 0 | 0 | ||||||||
Conj | Redness | 1 (ABC) | 2 (C) | 1 (ABC) | |||||||
Chemosis | 0 | 0 | 0 | ||||||||
Discharge | 0 | 1 | 0 | ||||||||
48 hours | Corneal | Opacity | 0 | 0 | 0 | ||||||
Area | 0 | 0 | 0 | ||||||||
Iris | 0 | 0 | 0 | ||||||||
Conj | Redness | 0 | 1(C) | 1(C) | |||||||
Chemosis | 0 | 0 | 0 | ||||||||
Discharge | 0 | 0 | 0 | ||||||||
72 hours | 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, and
C = Sclera
Table 7: Mean Values of Eye Irritation Scores (24 -72 h after instillation)
Animal No. | Mean 24 - 72 hours | |||
Corneal Opacity | Iris | Conjunctivae | ||
Redness | Chemosis | |||
469 | 0 | 0 | 0.3 | 0 |
470 | 0 | 0 | 1 | 0 |
471 | 0 | 0 | 0.7 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under current test conditions test substance is not considered irritating to the eye.
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