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EC number: 258-296-4 | CAS number: 53018-24-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 February 1985 to 03 April 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The rabbit eye irritation test according to test method No. OCTM05.01 dated 4.2.82 but with the following modifications:
- Treatment groups of the test material were diluted in Tween 80 (normally 10 and 50% dilutions) were omitted in this test.
- Only one animal was treated.
The study was conducted in accordance with S.O.P. 013 - GLP compliance:
- not specified
Test material
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene
- EC Number:
- 258-296-4
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene
- Cas Number:
- 53018-24-9
- Molecular formula:
- C11H16O
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene
- Test material form:
- liquid
- Details on test material:
- - Appearance: colourless
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Commercial Supplier
- Age at study initiation: 9 weeks old
- Weight at study initiation: 2.3 kg
- Housing: animals were housed individually in cages with wire-mesh floors
- Diet: certified pelleted commercial rabbit diet ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 µL
- Concentration: undiluted
- Duration of treatment / exposure:
- The test material was applied to the conjunctival sac formed by gently pulling the lower eyelid away from the eyeball. After treatment the eye was closed and the eyelids released.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- - Eyes were examined before application of the test material and at daily intervals afterwards with a slit lamp and corneal swelling was measured.
- Animals were observed carefully during and immediately after treatment for evidence of pain or discomfort. If excessive or persistent the substance was immediately washed out with copious quantities of physiological saline
- The eye was examined 15 minutes after treatment and thereafter at 2, 3, 4, 5 and 8 days and graded for corneal, conjunctival and iridial damage.
SCORING SYSTEM:
Cornea:
Normal = 0
Any change from normal, including slight dulling of corneal lustre = 0.5
Scattered or diffuse areas of opacity, or loss of corneal epithelium. Iris clearly visible = 1
Easily discernible, greyish, translucent areas, details of iris slightly obscured = 2
Grey-white areas, no details of iris visible, size of pupil barely discernible = 3
Complete corneal opacity, iris not discernible = 4
Iris
Normal = 0
Any divergence from normal, congestion of iridial vessels, deepening of folds = +
Severe congestion of iridial vessels or deepening of folds. Loss of iridial reflex to light = ++
Area of cornea or iris affected
Less than 1/4 of area affected = 1
Between 1/4 and 1/2 of area affected = 2
Between 1/2 and 3/4 of area affected = 3
Between 3/4 and whole area affected = 4
Conjunctivae
Redness (palpebral and bulbar conjunctivae and nictitating membrane)
Vessels normal = 0
Some vessels definitely injected = 1
Diffuse, crimson red, individual vessels not easily discernible = 2
Diffuse, beefy red = 3
Chemosis
No swelling = 0
Any swelling above normal = 1
Obvious swelling with partial eversion of eyelids = 2
Swelling with lids about half closed = 3
Swelling with lids more than half closed = 4
Discharge
No discharge = 0
Any discharge different from normal = 1
Discharge with moistening of lids and hairs just adjacent to the lids = 2
Discharge with moistening of lids and considerable area round eye = 3
Pannus
Healing
The insertion of 'N' as a score of corneal opacity denotes that the whole eye had returned to normal on the day indicated.
Corneal Swelling
Corneal thickness is measured with a slit-lamp 24 hours after treatment and thereafter at daily intervals until the thickness has returned to its pretreatment value. Slit-lamp readings are recorded in the Eye Treatment Book and the percentage corneal swelling is calculated from:
corneal swelling = (corneal thickness on day of measurement /corneal thickness before treatment) -1 x 100
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- One rabbit only was treated. The eye subsequently showed extensive loss of corneal epithelium with moderate corneal swelling and iritis. Conjunctivitis was moderate. The eye had healed normally by day 8. The test material is a moderate eye irritant at 100 μL dosage.
Any other information on results incl. tables
Table 1: Summary of Observations for the Test Material Treated Animal
Observations |
|||||
Discomfort |
Conjunctival Reactions |
Iritis |
Pannus |
Maximum Corneal Opacity (Max. 4) |
Maximum Corneal Swelling |
Yes |
Yes |
Yes |
No |
1 |
Moderate (46 – 80 %) |
Table 2: Daily Observations
Animal |
Region of Eye |
Day |
||||||
15 min |
2 |
3 |
4 |
5 |
8 |
|||
1 |
Cornea |
Opacity |
- |
1 |
0.5 |
0.5 |
0.5 |
N |
Area |
- |
1 |
1 |
1 |
1 |
- |
||
Swelling (%) |
- |
71 |
15 |
0 |
- |
- |
||
Conjunctivae |
Redness |
2 |
2 |
2 |
1 |
1 |
0 |
|
Chemosis |
2 |
2 |
1 |
1 |
0 |
0 |
||
Discharge |
- |
1 |
0 |
0 |
0 |
0 |
||
Iris |
- |
+4 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this study the test material was considered to be a moderate eye irritant.
- Executive summary:
The eye irritation potential of the test material was examined using a New Zealand White rabbit.
The test material was applied to the conjunctival sac formed by gently pulling the lower eyelid away from the eyeball. After treatment the eye was closed and the eyelids released.
One rabbit only was treated. The eye subsequently showed extensive loss of corneal epithelium with moderate corneal swelling and iritis. Conjunctivitis was moderate. The eye had healed normally by day 8.
Under the conditions of this study the test material was considered to be a moderate eye irritant.
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