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EC number: 269-522-6 | CAS number: 68259-31-4
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to the standardised guidelines OECD 437 and EU Method B.47 and in line GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 8-isopropyl-6-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- EC Number:
- 267-308-7
- EC Name:
- 8-isopropyl-6-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Cas Number:
- 67845-30-1
- Molecular formula:
- C13H20O
- IUPAC Name:
- 8-isopropyl-6-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Reference substance name:
- 7-isopropyl-5-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- EC Number:
- 299-795-7
- EC Name:
- 7-isopropyl-5-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Cas Number:
- 93904-56-4
- Molecular formula:
- C13H20O
- IUPAC Name:
- 7-isopropyl-5-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Reference substance name:
- rel-(1S,2R,4R)-1-isopropyl-4-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Cas Number:
- 36208-34-1
- Molecular formula:
- C13H20O
- IUPAC Name:
- rel-(1S,2R,4R)-1-isopropyl-4-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- Test article: Maceal
CAS NumberL 68259-31-4
Storage: 2 - 8 °C
Batch Number: SC00008034
Expiration date: 11 December 2014
Purity: 99.2%
Test animals / tissue source
- Species:
- other: Bovine corneas
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: Undiluted - Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- 1 hour 50 minutes
- Number of animals or in vitro replicates:
- Bovine corneas was used in place of live animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Corneal opacity
- Basis:
- mean
- Time point:
- other: 1 hour 50 minutes
- Score:
- 3.7
- Reversibility:
- not specified
- Irritation parameter:
- other: Corneal permeability
- Basis:
- mean
- Time point:
- other: 85 minutes
- Score:
- 0.013
- Reversibility:
- not specified
- Irritant / corrosive response data:
- CORNEAL OPACITY
Mean corrected opacity reading for test material: 3.7
Mean corrected opacity reading for negative control: 0.0
Mean corrected opacity reading for positive control: 21.3
The corneas treated with the positive control were cloudy following treatment.
CORNEAL PERMEABILITY
Mean corrected optical density for test material: 0.013
Mean corrected optical density for negative control: 0.000
Mean corrected optical density for positive control: 1.224
Any other information on results incl. tables
Table 1: Corneal Opacity
Test substance |
Cornea No. |
Initial Opacity |
Post Incubation Opacity |
Change in Opacity |
Mean Change in Opacity |
Corrected Opacity |
Mean Corrected Opacity |
Negative control (NaCl) |
2 |
4 |
4 |
0 |
0.33 |
-0.3 |
0 |
5 |
6 |
6 |
0 |
-0.3 |
|||
6 |
4 |
5 |
1 |
0.7 |
|||
Test material |
22 |
4 |
9 |
5 |
N/A |
4.7 |
3.7 |
32 |
4 |
7 |
3 |
2.7 |
|||
34 |
4 |
8 |
4 |
3.7 |
|||
Positive control (100 % Ethanol) |
11 |
3 |
25 |
22 |
N/A |
21.7 |
21.3 |
16 |
4 |
26 |
22 |
21.7 |
|||
17 |
2 |
23 |
21 |
20.7 |
Table 2: Corneal Permeability
Test substance |
Cornea No. |
Mean Blank OD490 |
OD490 |
Corrected OD490 |
Mean Corrected OD490 |
Final Corrected OD490 |
|
NaCl (negative control) |
2 |
N/A |
0.001 |
0.001 |
0.004 |
-0.002 |
0.000 |
5 |
0.006 |
0.006 |
0.002 |
||||
6 |
0.003 |
0.003 |
0.000 |
||||
Test material |
22 |
0.000 |
0.025 |
0.025 |
N/A |
0.021 |
0.013 |
32 |
0.014 |
0.014 |
0.010 |
||||
34 |
0.010 |
0.010 |
0.006 |
||||
100 % Ethanol (positive control) |
11 |
N/A |
1.042 |
1.042 |
N/A |
1.039 |
1.224 |
16 |
1.204 |
1.204 |
1.201 |
||||
17 |
1.436 |
1.436 |
1.432 |
Table 3: IVIS scores
Test substance |
IVIS |
Test material |
3.86 |
NaCl (negative control) |
0.00 |
100 % Ethanol (positive control) |
39.69 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test material produced an in vitro irritancy score (IVIS) of 3.86 in bovine corneas. Therefore a prediction cannot be made in respect of the potention for the test material to cause eye irritation.
However, based on the results of the animal experiement where no irritancy was observed, the substance is considered to be negative for in vitro eye irritation. - Executive summary:
The potential of the test material to cause serious eye irritation was investigated in vitro in a study conducted in accordance with the standardised guidelines OECD 437 and EU Method B.47 under GLP conditions using bovine corneas.
750 µL of undiluted test material was applied to each of three corneas and incubated for 10 minutes at 32 °C ± 1 °C. After incubation, each cornea was washed with media containing phenol red followed by media without phenol red and incubated horizontally for 1 hour 50 minutes and then measured for opacity.
Permeability of the corneas was measured by replacing the media in the anterior chamber with 1 mL of 4 mg/mL sodium fluorescein. The posterior chamber was filled with fresh media. The corneas were incubated vertically for 85 minutes at 32 °C ± 1 °C. The posterior chambers were the removed and three 350 µL aliquots of the media were taken for analysis of optical density at 490 nm.
The mean corrected opacity reading for the test material was determined to be 3.7. The mean corrected opacity reading for negative and positive controls was 0.0 and 21.3, respectively. The corneas treated with the positive control were cloudy following treatment.
The mean corrected optical density for the test material was determined to be 0.013. The mean corrected optical densities for negative and positive controls were 0.000 and 1.224, respectively.
Under the conditions of the test, the test material produced an in vitro irritancy score (IVIS) of 3.86 in bovine corneas. Therefore a prediction cannot be made in respect of the potention for the test material to cause eye irritation. However, based on the results of the animal experiement where no irritancy was observed, the substance is considered to be negative for in vitro eye irritation.
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