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EC number: 701-188-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-02-20 to 2006-02-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study following OECD guideline without any deviation.
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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- EC Number:
- 232-081-5
- EC Name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- Cas Number:
- 7785-53-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1R)-3-cyclohexene-1-methanol
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 233-986-8
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 10482-56-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1S)-3-cyclohexene-1-methanol
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- EC Number:
- 209-584-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- Cas Number:
- 586-81-2
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1-methyl-4-(1-methylethylidene)-cyclohexanol
- Reference substance name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Cas Number:
- 7299-41-4
- Molecular formula:
- C10H18O
- IUPAC Name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Reference substance name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- EC Number:
- 209-585-9
- EC Name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- Cas Number:
- 586-82-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-isopropyl-1-methyl-3-cyclohexen-1-ol
- Reference substance name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Cas Number:
- 27153-55-5
- Molecular formula:
- C13H24O
- IUPAC Name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Reference substance name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Cas Number:
- 7299-40-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Reference substance name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 208-135-9
- EC Name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 512-13-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1S,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 2217-02-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 207-353-1
- EC Name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 464-45-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1S,2R,4S)- bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1R,2S,4R)-borneol
- EC Number:
- 207-352-6
- EC Name:
- (1R,2S,4R)-borneol
- Cas Number:
- 464-43-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1R,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Test material form:
- liquid
- Details on test material:
- Batch No.: 049807
Purity: 67.2% (sum of the three main constituents)
Name of test material (as cited in study report): TERPINEOL MULTICONSTITUENT
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 30 November 2017
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
impurity 8
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome, Linxe, France
- Weight at study initiation: between 2.15 and 2.57 kg
- Housing: individual box installed in conventional air conditioned
-Diet(ad libitum): supplied by UAR, Villemoison s/Orange, France, ad libitum
-Water(ad libitum): tap water from public distribution system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 and 22
- Humidity (%): between 30 and 37
-Air changes: at least 10 cycles per hour
-Photoperiod (hours dark / hours light): 12/12
IN-LIFE DATES: From: 2006-02-20 To: 2006-02-26
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 - Duration of treatment / exposure:
- 24 hours, no washing done
- Observation period (in vivo):
- Observations performed at 1, 24, 48 and 72 h up to 21 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: According to the scale of lesion scores published in Directive n° 2004/73/EC and OECD guideline n°405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis(A)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness (C)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Remarks:
- lesion (D)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity (E)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis (A)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness (C)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Remarks:
- lesion (D)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity (E)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis (A)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness (C)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Remarks:
- lesion(D)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity (E)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Moderate redness at the conjunctival level associated with moderate chemosis and moderate opacity at the corneal level. All effects were totally reversible within the 7th day at the latest.
- Other effects:
- No data
Any other information on results incl. tables
Table 1: individual and mean scores of Conjunctivae, Iris and Cornea
Animal n° |
Time after treatment |
CONJUNCTIVAE |
IRIS |
CORNEA |
|
CHEMOSIS (A) |
REDNESS (C) |
LESION (D) |
OPACITY (E) |
||
A 7230 |
24 hours |
1 |
2 |
0 |
2 |
48 hours |
1 |
2 |
0 |
2 |
|
72 hours |
1 |
2 |
0 |
2 |
|
TOTAL MEAN |
3 |
6 |
0 |
6 |
|
1.0 |
2.0 |
0.0 |
2.0 |
||
A 7231 |
24 hours |
1 |
2 |
0 |
2 |
48 hours |
1 |
2 |
0 |
2 |
|
72 hours |
1 |
1 |
0 |
2 |
|
TOTAL |
3 |
5 |
0 |
6 |
|
MEAN |
1.0 |
1.7 |
0 .0 |
2.0 |
|
A 7232 |
24 hours |
2 |
2 |
0 |
2 |
48 hours |
2 |
1 |
0 |
0 |
|
72 hours |
1 |
1 |
0 |
0 |
|
TOTAL |
5 |
4 |
0 |
2 |
|
MEAN |
1.7 |
1. 3 |
0.0 |
0.7 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item is irritant to eyes and should be classified in Category 2 according to CLP regulation (EC) No 1272/2008.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy adults female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item in one eye while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded (scale of lesion scores according to Directive n° 2004/73/EC and OECD guideline 405).
The occular reactions observed during the study have been moderate. The individual mean scores for conjunctival chemosis were 1.0, 1.0 and 1.7, conjunctival redness scores were 2.0, 1.7 and 1.3, cornea opacity scores were 2.0, 2.0 and 0.7 and iris lesion scores were 0.0 for all animals.
At the conjuctivae level, a moderate redness, noted 24 h after the test item installation and totally reversible between the 6th and 7th day of the test, was associated with a moderate chemosis, noted 1h after the test item instillation and totally reversible between the 5th and 6th day of the test. At corneal level, moderate opacity was observed 24 h after the test substance administration and totally reversible between the 3rd and 6th day.
Therefore, the test item is considered as irritating to eyes according to CLP regulation (EC) No 1272/2008.
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