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EC number: 484-040-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05-14 February 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 405 with deviations: details on feeding and environmental conditions not reported; isomers ratio not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 2004/73/EC
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21
Test material
- Reference substance name:
- 4-METHYLENE-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-TETRAHYDRO-PYRAN
- Cas Number:
- 947237-93-6
- Molecular formula:
- C15 H24 O
- IUPAC Name:
- 4-METHYLENE-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-TETRAHYDRO-PYRAN
- Reference substance name:
- 4-METHYL-6-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Cas Number:
- 947237-84-5
- Molecular formula:
- C15 H24 O
- IUPAC Name:
- 4-METHYL-6-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Reference substance name:
- 4-METHYL-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Cas Number:
- 947237-75-4
- Molecular formula:
- C15 H24 O
- IUPAC Name:
- 4-METHYL-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Test material form:
- liquid
- Details on test material:
- - Physical state: Yellow liquid
- Storage condition of test material: Room temperature, protected from direct sun light
Constituent 1
Constituent 2
Constituent 3
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).
- Weight at study initiation: 2.19-2.58 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: 19-21 °C
- Humidity: 37-57 %
- Air changes: No data
- Photoperiod: No data
IN-LIFE DATES: 05 to 14 February 2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Test item was instilled, as supplied - 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 & Days 4 to 9 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 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:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 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:
- fully reversible within: 24 hours
- 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: 48 hours
- 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:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The conjunctivae reactions observed during the study have been slight to moderate and totally reversible in the three animals: a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 10th day of the test, associated with a slight chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 9th day of the test.
- 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
|
A7973 Female
|
1 h |
0 |
0 |
2 |
1 |
24 h |
0 |
0 |
1 |
1 |
|
48 h |
0 |
0 |
1 |
1 |
|
72 h |
0 |
0 |
1 |
1 |
|
Day 4 |
0 |
0 |
1 |
1 |
|
Day 5 |
0 |
0 |
1 |
1 |
|
Day 6 |
0 |
0 |
1 |
1 |
|
Day 7 |
0 |
0 |
1 |
1 |
|
Day 8 |
0 |
0 |
1 |
0 |
|
Day 9 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
3 |
3 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
1.0 |
1.0 |
|
A7975 Female
|
1 h |
0 |
0 |
1 |
1 |
24 h |
0 |
0 |
1 |
0 |
|
48 h |
0 |
0 |
1 |
0 |
|
72 h |
0 |
0 |
1 |
0 |
|
Day 4 |
0 |
0 |
1 |
0 |
|
Day 5 |
0 |
0 |
1 |
0 |
|
Day 6 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
3 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
1.0 |
0.0 |
|
A7978 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 |
0.0 |
0.3 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, 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 and Days 4 to 9 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.
The conjunctivae reactions observed during the study have been slight to moderate and totally reversible in the three animals: a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 10th day of the test, associated with a slight chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 9th day of the test.
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; 1.0, 1.0, 0.3 for conjunctivae score and 1.0, 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).
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