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EC number: 457-810-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 20 and 30 December, 2004.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD 405 Guideline. However, details on feeding and environmental conditions and isomers ratio are not reported. The substance is adequately identified. Therefore full validation applies.
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)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2004-07-01 / Signed on 2004-09-13.
Test material
- Reference substance name:
- -
- EC Number:
- 457-810-6
- EC Name:
- -
- Cas Number:
- 854737-08-9
- Molecular formula:
- C11 H18 O2
- IUPAC Name:
- 5-hept-6-enyloxolan-2-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless liquid
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- - Date received: 09 December 2004
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: no data
- Weight at study initiation: 2.37-2.53 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: no data
- Water: no data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20–21°C
- Humidity: 30-52 %
- Air changes: no data
- Photoperiod: no data
IN-LIFE DATES: From 20 to 30 December, 2004.
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:
- No washing was done
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 females
- 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: No
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:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis 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:
- 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:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis 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:
- 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:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis 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
- Irritant / corrosive response data:
- It was only recorded slight conjunctivae reactions, similar in the 3 animals and rapidly reversible:a slight enanthema noted 1 hour and 24 hours after the test product instillation associated with a discharge and a slight chemosis only noted 1 hour after the test product instillation.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Individual and Mean Scores for Cornea, Iris and Conjunctivae
Rabbit Number and Sex
| Time After Treatment
| Corneal Opacity
| Iris lesion | Conjunctival Redness
| Conjunctival Chemosis
|
A6399 Female
| 1 h | 0 | 0 | 1 | 1 |
24 h | 0 | 0 | 1 | 0 | |
48 h | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | |
Total (24, 48 and 72 h) | 0 | 0 | 1 | 0 | |
Mean (24, 48 and 72 h) | 0 | 0 | 0.3 | 0 |
Rabbit Number and Sex
| Time After Treatment
| Corneal Opacity
| Iris lesion | Conjunctival Redness
| Conjunctival Chemosis
|
A6407 Female
| 1 h | 0 | 0 | 1 | 1 |
24 h | 0 | 0 | 1 | 0 | |
48 h | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | |
Total (24, 48 and 72 h) | 0 | 0 | 1 | 0 | |
Mean (24, 48 and 72 h) | 0 | 0 | 0.3 | 0 |
Rabbit Number and Sex
| Time After Treatment
| Corneal Opacity
| Iris lesion | Conjunctival Redness
| Conjunctival Chemosis
|
A6408 Female
| 1 h | 0 | 0 | 1 | 1 |
24 h | 0 | 0 | 1 | 0 | |
48 h | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | |
Total (24, 48 and 72 h) | 0 | 0 | 1 | 0 | |
| Mean (24, 48 and 72 h) | 0 | 0 | 0.3 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item must not be classified according to CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
- Executive summary:
In an eye irritation study conducted according to OECD 405 guideline and in compliance with GLP, 3 New Zealand White female rabbits were exposed to 0.1 mL of test item 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 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
It was only recorded slight conjunctivae reactions, similar in the 3 animals and rapidly reversible:a slight enanthema noted 1 hour and 24 hours after the test product instillation associated with a discharge and a slight chemosis only noted 1 hour after the test product instillation.
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; 0.3, 0.3, 0.3 for conjunctivae score and 0.0, 0.0, 0.0 for chemosis score.
Under the test conditions, test item must not be classified according to CLP Regulation (EC) No. 1272 /2008 and Globally Harmonized System (GHS).
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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