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EC number: 220-585-8 | CAS number: 2825-82-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 to 30 June 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- study conducted according to OECD 404 Guideline - supposed to be GLP but not specified - with acceptable deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations: information on animals, environmental conditions and method not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations: information on animals, environmental conditions and method not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Remarks:
- supposed to be GLP but not specified
Test material
- Reference substance name:
- (3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
- EC Number:
- 220-585-8
- EC Name:
- (3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
- Cas Number:
- 2825-82-3
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,2S,6R,7S)-tricyclo[5.2.1.0^{2,6}]decane
- Test material form:
- liquid
- Details on test material:
- - Physical appearance: colourless liquid
- Storage conditions: at room temperature
Constituent 1
- Specific details on test material used for the study:
- Date of receipt: 08 June 2005
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not specified
- Weight during study: 2.49-2.95 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: not specified
- Water: not specified
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature: 18–23 °C
- Humidity: 59-68 %
- Air changes: not speicified
- Photoperiod: not specified
IN-LIFE DATES: 20 to 30 June 2005
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye serving as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- Ocular examinations were performed on both eyes 1, 24, 48 and 72 h & Days 4 to 9 after instillation, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENT
- 0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
REMOVAL OF TEST SUBSTANCE
- Washing: Not specified
SCORING SYSTEM: According to OECD guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Slight to moderate conjunctival reactions were noted, fully reversible:
moderate redness recorded 1 hour after instillation and fully reversible between day 6 and day 10 associated with a slight chemosis recorded 1 hour after instillation and fully reversible between day 3 and day 7. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Individual and mean scores of conjunctivae, iris and cornea
| Time / Animal No. | Cornea | Iris | Conjunctivae | |||||||||
| redness | chemosis | |||||||||||
| A6747 (#1) | A6748 (#2) | A6750 (#3) | A6747 (#1) | A6748 (#2) | A6750 (#3) | A6747 (#1) | A6748 (#2) | A6750 (#3) | A6747 (#1) | A6748 (#2) | A6750 (#3) | |
| 1h | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 1 | 1 | 1 |
| 24h | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 1 | 1 | 1 |
| 48h | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 1 | 0 |
| 72h | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 1 | 0 |
| 4 days | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 1 | 0 |
| 5 days | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| 6 days | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | - | 0 | 0 | - |
| 7 days | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | - | 0 | 0 | - |
| 8 days | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | - | 0 | 0 | - |
| 9 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 0 | 0 | - |
| mean 24/48/72h | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 2.0 | 1.3 | 1.0 | 1.0 | 0.3 |
-: not examined
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the test substance is classified as eye irritation Category 2 (H319: Causes severe eye irritation) according to Regulation (EC) N°1272-2008 (CLP) and as Category 2A "irritating to eyes" according to the GHS.
- Executive summary:
In an eye irritation study conducted according to OECD 405/EU Method B.5 guidelines and in compliance with GLP, 3 New Zealand White male rabbits were exposed to 0.1 mL of test substance in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 4 to 9 following treatment and graded according to the Draize method.
Fully reversible slight to moderate conjunctival reactions were noted during the observation period. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 2.0 / 2.0 / 1.3 for conjunctivae score and 1.0 / 1.0 / 0.3 for chemosis score.
Under the test conditions, test substance is classified as eye irritation Category 2 (H319: Causes severe eye irritation) according to Regulation (EC) N°1272-2008 (CLP) and as Category 2A "irritating to eyes" according to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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