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EC number: 943-328-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 16 to 23, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: GLP study comparable to OECD test guideline No 405. No details on test animals and environmental conditions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.42 - Federal Hazardous Substances Act Regulations CFR 16 P.125
- 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:
- yes
Test material
- Reference substance name:
- Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol
- EC Number:
- 943-328-8
- Molecular formula:
- Not applicable
- IUPAC Name:
- Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): MT-112
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Healthy young albino rabbits were used.
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:
- 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: Draize Scale.
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
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- - Animals showed conjunctival reactions (redness, chemosis and discharge) which were reversible within 2 days
- Other effects:
- None
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 (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
24 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 / 0 / 1 |
1 / 1 / 1 / 0 / 0 / 0 |
1 / 2 / 1 / 0 / 0 / 0 |
48 h |
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 |
72 h |
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 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 24h, 48h, and 72h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0.33 / 0.33 / 0.33 / 0.33 / 0 / 0.33 |
0.33 / 0.33 / 0.33 / 0 / 0 / 0 |
0.33 / 0.67 / 0.33 / 0 / 0 / 0 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
- |
- |
- |
2 days |
2 days |
2 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 2 days. Therefore, the test material is not classified as irritant to the eyes.
- Executive summary:
In an eye irritation study, 0.1 mL 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 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 Draize scale of scoring ocular lesions.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 0.33 / 0.33 / 0.33 / 0.33 / 0 / 0.33 for redness, 0.33 / 0.33 / 0.33 / 0.33 / 0 / 0.33 for chemosis, 0.33 / 0.33 / 0.33 / 0.33 / 0 / 0.33 for iris lesions and corneal opacity. The observed conjunctival reactions were disappeared completely within 2 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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