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EC number: 209-235-5 | CAS number: 562-74-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Nov 2017 - Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- Jul 2013
- Deviations:
- yes
- Remarks:
- decision criteria
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- Dec 2010
- Deviations:
- yes
- Remarks:
- decision criteria
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-menth-1-en-4-ol
- EC Number:
- 209-235-5
- EC Name:
- p-menth-1-en-4-ol
- Cas Number:
- 562-74-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-methyl-1-(propan-2-yl)cyclohex-3-en-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: BASF SE, Ludwigshafen, Germany
- Batch No.of test material: 01767-1010
- Identity: Confirmed
- Purity: 97.3%
- Expiry date: 17 Mar 2019
- Physical state / color: Liquid / colorless, clear
- pH value: ca. 5 (undiluted test substance)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; under light exclusion
- Stability under test conditions: The stability was guaranteed
- Homogeneity: The test substanc was homogeneous by visual inspection
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was applied undiluted, thus, no preparation was necessary.
Test animals / tissue source
- Species:
- other: Isolated bovine cornea
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Alzey, Emil Färber GmbH & Co. KG, Robert-Bosch-Strasse 23, 55232 Alzey, Germany
- Characteristics of donor animals (age): minimum 12 months, maximum 60 months
- Detailed information of ocular tissue: Bovine eyes are obtained as a by-product of freshly slaughtered cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl
- Concentration (if solution): undiluted test substance
VEHICLE
- not applicable
CONTROLS
- Amount(s) applied (volume or weight with unit): 750 µl - Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS: yes
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: yes
POSITIVE CONTROL USED: yes
APPLICATION DOSE AND EXPOSURE TIME: 750 µl, 10 min
TREATMENT METHOD: not specified
POST-INCUBATION PERIOD: yes/no. If YES please specify duration
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
- POST-EXPOSURE INCUBATION: 2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: see "any other information on materials and methods"
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea number 19
- Value:
- 28.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of corrosive potential
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea number 20
- Value:
- 26.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of corrosive potential
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea number 21
- Value:
- 24.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of corrosive potential
Any other information on results incl. tables
Table 1: Opacity score of the test substance, the negative control and the positive control
Test substance identification |
Cornea- No. |
Initial opacity |
Final opacity |
Opacity Change |
Corrected Opacity Change |
Mean |
SD |
|
19 |
4.5 |
21.3 |
16.8 |
10.6 |
|
|
17/0495-1 |
20 |
3.7 |
17.0 |
13.3 |
7.2 |
9.0 |
1.7 |
|
21 |
3.8 |
18.9 |
15.2 |
9.0 |
|
|
|
10 |
3.9 |
11.0 |
7.1 |
NA |
|
|
NC |
11 |
2.8 |
7.6 |
4.8 |
NA |
6.1 |
1.2 |
|
12 |
4.0 |
10.5 |
6.5 |
NA |
|
|
|
13 |
4.7 |
32.7 |
27.9 |
21.8 |
|
|
PC1 |
14 |
2.8 |
34.3 |
31.6 |
25.4 |
21.9 |
3.5 |
|
15 |
4.6 |
29.0 |
24.5 |
18.3 |
|
|
|
16 |
5.3 |
109.4 |
104.1 |
98.0 |
|
|
PC2 |
17 |
5.2 |
97.5 |
92.3 |
86.2 |
93.7 |
6.5 |
|
18 |
3.8 |
106.8 |
103.0 |
96.8 |
|
|
Table 2: Permeability score of the test substance, the negative and the positive control
Test substanceidentification |
Cornea-No. |
MeanOD490 |
DilutionFactor |
Mean CorrectedOD490 |
Mean |
SD |
|
19 |
1.170 |
1 |
1.165 |
|
|
17/0495-1 |
20 |
1.270 |
1 |
1.266 |
1.161 |
0.107 |
|
21 |
1.057 |
1 |
1.053 |
|
|
|
10 |
0.002 |
1 |
NA |
|
|
NC |
11 |
0.004 |
1 |
NA |
0.004 |
0.003 |
|
12 |
0.007 |
1 |
NA |
|
|
|
13 |
0.986 |
1 |
0.982 |
|
|
PC1 |
14 |
0.552 |
1 |
0.548 |
0.734 |
0.223 |
|
15 |
0.677 |
1 |
0.672 |
|
|
|
16 |
0.217 |
1 |
0.212 |
|
|
PC2 |
17 |
0.559 |
1 |
0.555 |
0.388 |
0.171 |
|
18 |
0.401 |
1 |
0.397 |
|
|
Table 3: In Vitro Irritancy Score (IVIS) of the test substance, the negative and the positive control
Test substanceidentification |
Cornea- No. |
Opacity per cornea |
Permeability per cornea |
per cornea |
IVIS per group |
|
mean |
SD |
|||||
|
19 |
10.6 |
1.165 |
28.1 |
|
|
17/0495-1 |
20 |
7.2 |
1.266 |
26.2 |
26.4 |
1.7 |
|
21 |
9.0 |
1.053 |
24.8 |
|
|
|
10 |
7.1 |
0.002 |
7.2 |
|
|
NC |
11 |
4.8 |
0.004 |
4.8 |
6.2 |
1.2 |
|
12 |
6.5 |
0.007 |
6.6 |
|
|
|
13 |
21.8 |
0.982 |
36.5 |
|
|
PC1 |
14 |
25.4 |
0.548 |
33.6 |
32.9 |
4.1 |
|
15 |
18.3 |
0.672 |
28.4 |
|
|
|
16 |
98.0 |
0.212 |
101.1 |
|
|
PC2 |
17 |
86.2 |
0.555 |
94.5 |
99.5 |
4.4 |
|
18 |
96.8 |
0.397 |
102.8 |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results of the BCOP and EpiOcular Tests and by applying the evaluation criteria, it was concluded that the test substance shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
- Executive summary:
The objective was to assess the eye irritating potential of the test substance. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test.
BCOP
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL undiluted test substance to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hour postincubation period.
In addition to the test substance, a negative control (NC; deionized water) and two positive controls (PC1 / PC2; 100% ethanol / 100% dimethylformamide) were applied to three corneas each.
Corneal opacity was quantitatively measured as the amount of light transmitted through the cornea. Permeability was quantitatively measured as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance.
The following results were obtained in the BCOP Test:
Test substance identification
MeanOpacityValue
MeanPermeabilityValue
Mean In Vitro Irritancy Score
Test substance
9.0
1.161
26.4
NC
6.1
0.004
6.2
PC1
21.9
0.734
32.9
PC2
93.7
0.388
99.5
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