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EC number: 260-486-7 | CAS number: 56973-85-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 21 to 24, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
- EC Number:
- 260-486-7
- EC Name:
- 1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
- Cas Number:
- 56973-85-4
- Molecular formula:
- C13H20O
- IUPAC Name:
- 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
- Reference substance name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
- Cas Number:
- 56973-84-3
- Molecular formula:
- C13H20O
- IUPAC Name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
- Test material form:
- liquid
- Remarks:
- Colorless to pale yellow liquid
- Details on test material:
- - Storage condition of test material: In a refrigerator (2-8°C)
- Stability under test conditions: Stable at storage conditions
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: 13 weeks
- Weight at study initiation: Animal n°1: 2613g ; Animal n°2: 2726g ; Animal n°3: 2581g
- Housing: Animals were housed individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 64/99) from Provimi Kliba AG, 4303 Kaiseraugst, Switzerland
- Water: Community tap water from Itingen, ad libitum, in water bowls.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: June 15, 1999 To: June 24, 1999.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- 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, #2 and #3
- 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, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- 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:
- Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.00. In all animals, slight reddening of the conjuctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was noted, one hour after treatment. In one animal, slight watery discharge persisted until 24 hours. All signs of irritation were reversible after 48 hours.
- Other effects:
- - No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occured.
- No staining by the test article was observed.
- The body weight of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Table 7.3.2/1: Eye irritation response data for each animal at each observation time
| Score at time point | Cornea | Iris | Conjunctivae | |
| Opacity (/4) | (/2) | Redness (/3) | Chemosis (/4) | |
| 1 h (Day 1) | 0 / 0 / 0 | 0 / 0 / 0 | 1 / 1 / 1 | 1 / 0 / 0 |
| 24 h (Day 1) | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 |
| 48 h (Day 2) | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 |
| 72 h (Day 3) | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 |
| Average 24, 48 and 72 h | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 | 0 / 0 / 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according the GHS.
- Executive summary:
In an eye irritation study performed according to the EU Method B.5 and OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the left eye of 3 New Zealand White rabbits (1 male and 2 females). The lids are then gently held together for about one second to prevent loss of the article. The right eye remained untreated and served as the reference control. Animals were observed at 1, 24, 48 and 72 h after test material instillation. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity) were scored according to the Draize scale.
In all animals, slight reddening of the conjuctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was noted, one hour after treatment. In one animal, slight watery discharge persisted until 24 hours. All signs of irritation were reversible after 48 hours.
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, iris score, conjunctivae score and chemosis score.
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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