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EC number: 246-430-4 | CAS number: 24720-09-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 09 to 16, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- The study was performed according to 16 CFR 1500.42 (US) test guideline. The study was conducted prior to the OECD Test Guideline No. 405 but the protocol is similar to that guidance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, p. 27019, 27 September 1973.
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No details on test animals and environmental conditions
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- (E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one
- EC Number:
- 246-430-4
- EC Name:
- (E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one
- Cas Number:
- 24720-09-0
- Molecular formula:
- C13H20O
- IUPAC Name:
- 1-(2,6,6-trimethylcyclohex-2-en-1-yl)but-2-en-1-one
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): PA 279-7
- Other: Density: Approximately 1 g/mL
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS: Healthy young adult albino rabbits were used.
IN-LIFE DATES: From: July 09, 1979 To: July 16, 1979
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 g - Duration of treatment / exposure:
- Eyes of the animals were not rinsed.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: According to “Illustrated guide for grading eye irritation by hazardous substances”.
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- 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
- 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
- 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 #4
- 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 #5
- 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
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #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:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- 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
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Animals showed conjunctival reactions (redness, chemosis and discharge) which were reversible within 5 days.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Mean eye irritation response data of 6 animals at each observation time
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
24 h |
0 |
0 |
0 |
0.83 |
0.67 |
1 |
48 h |
0 |
0 |
0 |
0.33 |
0.17 |
0.33 |
72 h |
0 |
0 |
0 |
0 |
0.17 |
0.33 |
Mean |
0 |
0 |
0 |
0.39 |
0.33 |
0.55 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time for reversion |
- |
- |
- |
3 days |
5 days |
5 days |
Table 7.3.2/2: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
24 h (Day 1) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 2 / 1 / 0 / 0 / 1 |
1 / 1 / 1 / 0 / 0 / 1 |
1 / 3 / 2 / 0 / 0 / 0 |
48 h (Day 2) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 2 / 0 / 0 / 0 / 0 |
0 / 1 / 0 / 0 / 0 / 0 |
0 / 2 / 0 / 0 / 0 / 0 |
72 h (Day 3) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 1 / 0 / 0 / 0 / 0 |
0 / 2 / 0 / 0 / 0 / 0 |
Day 5 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Day 7 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
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 |
0 / 0 / 0 / 0 / 0 / 0 |
0.33 / 1.33 / 0.33 / 0 / 0 / 0.33 |
0.33 / 1 / 0.33 / 0 / 0 / 0.33 |
0.33 / 2.33 / 0.67 / 0 / 0 / 0 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
- |
- |
- |
3 days |
5 days |
5 days |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material induced mild irritation being reversible within 5 days. Therefore, the test material is not classified as irritant to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study, 0.1 g of undiluted test material was instilled into the right eye of 6 albino rabbits while the left eye remained untreated and served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 24, 48 and 72 h after instillation of test material into eyes and then on Days 5 and 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the “Illustrated guide for grading eye irritation by hazardous substances”.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were as follows: 0.33 / 1.33 / 0.33 / 0 / 0 / 0.33 for redness, 0.33 / 1 / 0.33 / 0 / 0 / 0.33 for chemosis, 0 / 0 / 0 / 0 / 0 / 0 for iris lesions and 0 / 0 / 0 / 0 / 0 / 0 for corneal opacity. The observed conjunctival reactions were fully reversible within 5 days.
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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