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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 24 and 28 May, 2010.
- 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 without any deviation. The substance is adequately identified, but some data on composition is missing. Therefore validation applies with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- Regulation n° 440/2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2009-09-03 / Signed on 2009-12-10
Test material
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 1]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 1]
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 2]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 2]
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 3]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 3]
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 4]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 4]
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless translucent liquid
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- - Date received: 10 May 2010
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: 2.12 - 2.53 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS - C15), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: fifteen changes per hour.
- Photoperiod: 12 hours light/12 hours dark.
IN-LIFE DATES: from 24 to 28 May, 2010.
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 and day 4 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: 4 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 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:
- 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to moderate and totally reversible in the three animals:
- a moderate redness, noted 1 hour after the test item instillation and totally reversible between day 2 and day 4,
- a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between day 1 and day 2. - 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
|
A0246 Female
| 1 h | 0 | 0 | 2 | 2 |
24 h | 0 | 0 | 1 | 1 | |
48 h | 0 | 0 | 1 | 0 | |
72 h | 0 | 0 | 1 | 0 | |
Day 4 | 0 | 0 | 0 | 0 | |
Total (24, 48 and 72 h) | 0 | 0 | 3 | 0 | |
| Mean (24, 48 and 72 h) | 0 | 0 | 1 | 0.3 |
Rabbit Number and Sex
| Time After Treatment
| Corneal Opacity
| Iris lesion | Conjunctival Redness
| Conjunctival Chemosis
|
A0250 Female
| 1 h | 0 | 0 | 2 | 1 |
24 h | 0 | 0 | 1 | 0 | |
48 h | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | |
Day 4 | 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 |
Rabbit Number and Sex
| Time After Treatment
| Corneal Opacity
| Iris lesion | Conjunctival Redness
| Conjunctival Chemosis
|
A0251 Female
| 1 h | 0 | 0 | 2 | 2 |
24 h | 0 | 0 | 2 | 1 | |
48 h | 0 | 0 | 1 | 0 | |
72 h | 0 | 0 | 0 | 0 | |
Day 4 | 0 | 0 | 0 | 0 | |
Total (24, 48 and 72 h) | 0 | 0 | 3 | 1 | |
| Mean (24, 48 and 72 h) | 0.0 | 0.0 | 1.0 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test material is not classified as irritating to eyes according to the annex I of the Regulation (EC) No. 1272 /2008 (CLP) and to the 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 day 4 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 ocular reactions observed during the study have been slight to moderate and totally reversible in the three animals. A moderate redness, noted 1 hour after the test item instillation and totally reversible between day 2 and day 4. A slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between day 1 and day 2.
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, 0.3, 1.0 for conjunctivae score and 0.3, 0.0, 0.3 for chemosis score.
Under the test conditions, test material is not classified as irritating to eyes according to the annex I of the Regulation (EC) No. 1272 /2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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