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EC number: 700-729-0 | CAS number: 1369500-14-0
- 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
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- 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
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- Nanomaterial aspect ratio / shape
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Sediment toxicity
- Terrestrial toxicity
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- Biotransformation and kinetics
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- 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
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- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental dates: 16 February 2011 to 17 February 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 437 guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1R,4S,4aR,8aS)-9-(dichloromethylidene)octahydro-1,4-methanonaphthalene-5,8-dione
- EC Number:
- 700-729-0
- Cas Number:
- 1369500-14-0
- Molecular formula:
- C12H12Cl2O2
- IUPAC Name:
- (1R,4S,4aR,8aS)-9-(dichloromethylidene)octahydro-1,4-methanonaphthalene-5,8-dione
- Details on test material:
- - Molecular formula (if other than submission substance): C12H12Cl2O2
- Molecular weight (if other than submission substance): 259.1
- Physical state: Brown powder
- Storage condition of test material: <30°C
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine corneas
- Strain:
- other: Not applicable
- Details on test animals or tissues and environmental conditions:
- No test animals were used.
Bovine corneas supplied by A Traves and Son Ltd., Abattoirs, York, United Kingdom. Following slaughter the eyes were removed, completely immersed in Hanks’ Balanced Salt Solution (containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL) in a suitably sized container and transported on the same day to the testing facility. Upon arrival at the test facility the corneas were excised from the eyes and loaded onto specifically designed holders, filled with pre-warmed Eagle's Minimal Essential Medium (EMEM) and incubated at 32°C for 1 hour.
Test system
- Vehicle:
- other: No vehicle used
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 mg
- Concentration (if solution): undiluted test material - Duration of treatment / exposure:
- 4 hour incubation at 32°C
Further 1.5 hours at 32°C to achieve the permeability end point - Number of animals or in vitro replicates:
- No animals were used in this test.
Three corneas were used per test substance, positive and negative control - Details on study design:
- APPLICATION OF TEST SUBSTANCE AND CONTROL MATERIALS:
The test article did not produce a suitable suspension or solution at a concentration of 20% w/v in 0.9% sodium chloride solution, therefore the solid test article was used as supplied. 750 mg of test article was applied to the anterior surface of each of three corneas followed by a four hour incubation at 32°C ± 1°C.
A volume of 750 µL of the negative (0.9% sodium chloride) or positive control (20% w/v Imidazole) was similarly applied to further groups of three corneas. These groups were subject to the procedures detailed above.
REMOVAL OF TEST SUBSTANCE
- Washing: Each cornea was washed with media containing phenol red (as a pH indicator) until this indicator showed no pH effect occurring (and demonstrating that the test article had been removed successfully). The corneas were then washed once in media without phenol red, the opacities measured and the anterior chamber emptied
- Time after start of exposure: 4 hours
SCORING SYSTEM:
In vitro Irritation Score (IVIS)
TOOL USED TO ASSESS SCORE:
For the permeability endpoint, 1 mL of sodium fluorescein (5 mg/mL solution) was added into the anterior chamber and the corneas were incubated at 32°C ± 1°C for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and held in a labelled tube. Three 350 μL aliquots of this media (per cornea) were transferred to a 96 well plate and analysed for optical density at 490 nanometers (OD490).
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 16.37
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The In Vitro Irritation Score (IVIS) for the test article is calculated as follows:
IVIS = mean opacity value + (15 x mean permeability value)
The test article will be concluded as a corrosive or severe irritant if it causes damage to the cornea such that the IVIS is >55.1.
The following mean in vitro irritation scores (IVIS) were calculated. The test article produced an IVIS of 16.37 and the positive control article produced an IVIS of 84.89 (within two Standard Deviations of the historical mean).
These results indicate that the IVIS for the test article was not ≥55.1 and therefore the test article may be considered not to be a corrosive or severe irritant, in compliance with the test guideline. The positive control showed an appropriate response in the assay system. The assay acceptance criteria were achieved. No other test substance related effects were observed.
Any other information on results incl. tables
Corneal Opacity
Test chemical |
Cornea number |
Initial opacity reading |
Post incubation opacity |
Change in opacity |
Average change in opacity (negative control) |
Corrected opacity |
Mean opacity |
Negative control |
4 |
2 |
4 |
2 |
2.00 |
0.0 |
0.0 |
1 |
2 |
4 |
2 |
|
0.0 |
||
22 |
2 |
4 |
2 |
|
0.0 |
||
Positive control |
20 |
3 |
73 |
70 |
N/A |
68.0 |
60.0 |
6 |
1 |
59 |
58 |
|
56.0 |
||
10 |
1 |
59 |
58 |
|
56.0 |
||
Test article |
24 |
3 |
20 |
17 |
N/A |
15.0 |
16.0 |
21 |
1 |
18 |
17 |
|
15.0 |
||
11 |
2 |
22 |
20 |
|
18.0 |
Permeability
Test chemical |
Cornea number |
OD490reading |
Corrected OD490 |
Mean negative control corrected OD490 |
Final corrected OD490 |
Average group corrected OD490 |
|
Negative control |
4 |
0.050 |
0.005 |
0.005 |
-0.001 |
0.000 |
|
1 |
0.049 |
0.003 |
|
-0.002 |
|||
22 |
0.053 |
0.008 |
|
0.002 |
|||
Positive control |
20 |
1.212 |
1.166 |
N/A |
1.161 |
1.659 |
|
6 |
1.966 |
1.921 |
|
1.916 |
|||
10 |
1.952 |
1.907 |
|
1.901 |
|||
Test article |
24 |
0.081 |
0.036 |
N/A |
0.030 |
0.025 |
|
21 |
0.073 |
0.028 |
|
0.022 |
|||
11 |
0.072 |
0.026 |
|
0.021 |
|||
Mean blank |
0.046 |
|
Calculated IVIS
Test chemical |
Mean opacity |
Mean permeability x 15 |
IVIS (mean opacity + (15 x mean permeability)) |
|
|
|
|
Negative control |
0 |
0 |
0 |
Positive control |
60 |
24.89 |
84.89 |
Test article |
16 |
0.37 |
16.37 |
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive or a severe irritant
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test subtance was considered not to cause corrosion or severe irritation to the eye under the conditions of the assay.
- Executive summary:
The result indicates that the substance should be non-corrosive to the eye and not a severe eye irritant. Without furtherin vivo data the result has to be considered as inconclusive regarding classification.
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