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EC number: 224-957-0 | CAS number: 4573-50-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June - 04 July 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- / GLP guideline study with minor deviations (no information about animal age, body weight determined only once)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- yes
- Remarks:
- / GLP guideline study with minor deviations (no information about animal age, body weight determined only once)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 30 May 2008
- Deviations:
- yes
- Remarks:
- / GLP guideline study with minor deviations (no information about animal age, body weight determined only once)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one
- EC Number:
- 224-957-0
- EC Name:
- (R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one
- Cas Number:
- 4573-50-6
- Molecular formula:
- C10H16O
- IUPAC Name:
- (R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits, Chbb:HM(SPF) - Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, Biberach, Germany
- Weight at study initiation: 1.5 - 1.7 kg (females)
- Housing: individual in PPO cages with perforated floor
- Diet : pelleted diet Altromin 2123 (Altromin, Lage, Lippe Germany), ad libitum
- Water: water (acidified with hydrochloric acid, pH 2,5), ad libitum (analysis was performed)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/ 12
IN-LIFE DATES: From: 26 June To: 04 July 2000
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test article were applied into one eye of the rabbits. - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 h and 7 days after the treatment - Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- before fluorescein application
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- before fluorescein application
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- before fluorescein application
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Based on the readings before fluorescein application, all 4 animals showed a cornea opacity (scored with 1) after 1h , which was reversible within 72 h in 1/4 animals. All animals showed an Iris score of 1 after 1 h, which was reversible within 72h in 2/4 animals. Conjunctivae was observed in all animals after 1 h (scored with 3 in 1 animal and with 2 in the other 3 animals). After 24 h all animals showed a conjunctivae scored with 2. After 48 h or 72 h the scoring decreased to 1 (in 2 or 1 animal, respectively). The fourth animal showed a consistent scoring of 2 within the 72 h. Chemosis was observed in all animals after 1 h (scored with 2). 2/2 animals showed a decrease in scoring to 1 after 24 h, the other 2 animals after 48 h.
7 days after application of the test article all four animals were free of any signs of eye irritation.
Any other information on results incl. tables
Table 1: Individual scores of eye irritation
Rabbit # |
Time [h] |
conjunctivae |
iris |
cornea |
cornea (after Fluorescein) |
|
redness |
chemosis (swelling) |
|||||
1 |
1 |
3 |
2 |
1 |
1 |
- |
24 |
2 |
2 |
1 |
1 |
1 |
|
48 |
2 |
1 |
1 |
1 |
1 |
|
72 |
1 |
1 |
0 |
1 |
1 |
|
mean |
1.7 |
1.3 |
0.7 |
1.0 |
1.0 |
|
2 |
1 |
2 |
2 |
1 |
1 |
- |
24 |
2 |
1 |
1 |
1 |
1 |
|
48 |
1 |
1 |
1 |
1 |
1 |
|
72 |
1 |
1 |
0 |
0 |
1 |
|
mean |
1.3 |
1.0 |
0.7 |
0.7 |
1.0 |
|
3 |
1 |
2 |
2 |
1 |
1 |
- |
24 |
2 |
2 |
1 |
1 |
1 |
|
48 |
2 |
1 |
1 |
1 |
1 |
|
72 |
2 |
1 |
1 |
1 |
0 |
|
mean |
2.0 |
1.3 |
1.0 |
1.0 |
0.7 |
|
4 |
1 |
2 |
2 |
1 |
1 |
- |
24 |
2 |
1 |
1 |
1 |
1 |
|
48 |
1 |
1 |
1 |
1 |
1 |
|
72 |
1 |
1 |
0 |
1 |
1 |
|
mean |
1.3 |
1.0 |
0.7 |
1.0 |
1.0 |
|
Iris: 0 - 2 numerical scores, Redness: 0 - 3 numerical scores, Chemosis and Cornea opacity score : 0 - 4 numerical scores
Only the scores from the readings after 24, 48 and 72 hours are included in the calculation of the individual mean scores.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- CLP: Eye irrit 2, H319
- Executive summary:
The eye irritation potential of the test substance was determined by an in vivo eye irritation test according to OECD Guideline 405 and in compliance with GLP (2016).Application of the test substance to the rabbit eye resulted in a mean corneal opacity score of 1 in 3/4 animals, which was reversible within maximum 7 days. Thus, the test substance is considered to be irritant to the eye.
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