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EC number: 948-260-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Aug 2018- Sep 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland Pfalz
Test material
- Reference substance name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
- EC Number:
- 701-295-5
- Molecular formula:
- C12 H18 O
- IUPAC Name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
Constituent 1
- Specific details on test material used for the study:
- Test material is the main constituent of the registered substance.
Test animals / tissue source
- Species:
- cattle
- 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
- Age of donor animals: Minimum 12 months, maximum 60 months
- indication of any existing defects or lesions in ocular tissue samples: Corneas free of defects (opacity, scratches, pigmentation etc.) were selected for the experiments
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL undiluted test substance
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- Corneas free of defects were selected
- Dissection with a 2 to 3 mm rim of sclera
- Corneas were mounted in cornea holders consisting of 2 chambers (anterior/posterior)
- Equilibration with pre-warmed Eagle’s MEM (without phenol red) at about 32°C for at least 1 h
QUALITY CHECK OF THE ISOLATED CORNEAS
- initial corneal opacity was analyzed; any corneas that showed macroscopic tissue damage or an opacity value < 556 opacity units
were discarded
NUMBER OF REPLICATES : 3 corneas / treatment group
NEGATIVE CONTROL USED
- 750 μL deionized water
POSITIVE CONTROL USED
- PC1: 100% ethanol (750 µL)
- PC 2: 100% dimethylformamide (750 µL)
APPLICATION DOSE AND EXPOSURE TIME
- 750 μL undiluted liquid test substance
- 10 min
POST-INCUBATION PERIOD: yes
- 2 h
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least 3 times
- POST-EXPOSURE INCUBATION: 2h at about 32°C
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer analysis
- Corneal permeability: Passage of sodium fluorescein solution (4 mg/mL) was measured (after incubation for 90 ± 5 min) with the aid of spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
- Mean corneal opacity and permeability values of each treatment group were used for IVIS calculations
- IVIS calculation per treatment group after calculation of IVIS per cornea
DECISION CRITERIA:
- Decision criteria according to the OECD Guideline 437 for evaluation of results
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 3.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability score
- Value:
- 0.001
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Value:
- 3.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Tab. 2: Opacity score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Initial opacity |
Final opacity |
Opacity Change |
Corrected Opacity Change |
Mean |
SD |
|
13 |
6.0 |
15.4 |
9.4 |
5.0 |
|
|
18/0072-2 |
14 |
4.7 |
9.4 |
4.7 |
0.3 |
3.2 |
2.5 |
|
15 |
2.9 |
11.4 |
8.5 |
4.2 |
|
|
|
1 |
4.6 |
8.5 |
3.9 |
NA |
|
|
NC |
2 |
4.1 |
7.9 |
3.7 |
NA |
4.3 |
0.9 |
|
3 |
5.2 |
10.6 |
5.4 |
NA |
|
|
|
4 |
4.5 |
32.7 |
28.2 |
23.9 |
|
|
PC1 |
5 |
4.4 |
34.6 |
30.1 |
25.8 |
24.8 |
1.0 |
|
6 |
4.8 |
33.9 |
29.1 |
24.8 |
|
|
|
7 |
5.6 |
110.7 |
105.0 |
100.7 |
|
|
PC2 |
8 |
4.8 |
102.4 |
97.6 |
93.3 |
102.1 |
9.6 |
|
9 |
6.3 |
123.0 |
116.7 |
112.3 |
|
|
Tab. 3: Permeability score of the test substance, the NC and the PC
Test substance identification |
Cornea- No. |
Mean OD490 |
Dilution Factor |
Mean Corrected OD490 * |
Mean |
SD |
|
13 |
0.002 |
1 |
0.000 |
|
|
18/0072-2 |
14 |
0.005 |
1 |
0.003 |
0.010 |
0.015 |
|
15 |
0.029 |
1 |
0.027 |
|
|
|
1 |
0.000 |
1 |
NA |
|
|
NC |
2 |
0.000 |
1 |
NA |
0.001 |
0.001 |
|
3 |
0.002 |
1 |
NA |
|
|
|
4 |
0.842 |
1 |
0.841 |
|
|
PC1 |
5 |
0.534 |
1 |
0.533 |
0.751 |
0.190 |
|
6 |
0.881 |
1 |
0.880 |
|
|
|
7 |
0.407 |
1 |
0.406 |
|
|
PC2 |
8 |
0.483 |
1 |
0.482 |
0.389 |
0.102 |
|
9 |
0.280 |
1 |
0.279 |
|
|
* Negative values are set to zero for further calculation
Tab. 4: In Vitro Irritancy score (IVIS) of the test substance, the NC and the PC
Test substance identification |
Cornea No. |
Opacity per cornea |
Permeability per cornea |
per cornea |
IVIS per group |
|
mean |
SD |
|||||
|
13 |
5.0 |
0.000 |
5.0 |
|
|
18/0072-2 |
14 |
0.3 |
0.003 |
0.4 |
3.3 |
2.6 |
|
15 |
4.2 |
0.027 |
4.6 |
|
|
|
1 |
3.9 |
0.001 |
3.9 |
|
|
NC |
2 |
3.7 |
0.001 |
3.8 |
4.4 |
0.9 |
|
3 |
5.4 |
0.002 |
5.4 |
|
|
|
4 |
23.9 |
0.841 |
36.5 |
|
|
PC1 |
5 |
25.8 |
0.533 |
33.8 |
36.1 |
2.1 |
|
6 |
24.8 |
0.880 |
38.0 |
|
|
|
7 |
100.7 |
0.406 |
106.8 |
|
|
PC2 |
8 |
93.3 |
0.482 |
100.5 |
107.9 |
8.1 |
|
9 |
112.3 |
0.279 |
116.5 |
|
|
HISTORICAL CONTROL DATA
Tab. 5: Historic range of NC (protocol for liquids and surfactants)
Historic period: Jan 2015 - Jul 2018 (no. of studies performed: 22)
Opacity |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
5.1 |
1.8 |
8.8 |
1.4 |
Permeability (OD490) |
Mean OD |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
0.004 |
0.003 |
0.009 |
-0.002 |
Tab.6: Historic range of PC1 (100% ethanol)
Historic period: Jan 2015 - Jul 2018 (no. of studies performed: 21)
Opacity |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
24.4 |
4.2 |
32.8 |
16 |
Permeability (OD490) |
Mean OD |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
0.821 |
0.17 |
1.162 |
0.481 |
In Vitro Irritation Score (IVIS) |
Mean OD |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
36.7 |
5.1 |
47.0 |
26.5 |
Tab. 7: Historic range of PC2 (100% dimethylformamide)
Historic period: May 2015 - Jul 2018 (no. of studies performed: 18)
Opacity |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
92.3 |
8.0 |
108.3 |
76.4 |
Permeability (OD490) |
Mean OD |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
0.577 |
0.184 |
0.944 |
0.209 |
In Vitro Irritation Score (IVIS) |
Mean OD |
SD |
Mean + 2 SD |
Mean – 2 SD |
|
101.0 |
8.2 |
117.4 |
84.5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No indication of corrosion
- Conclusions:
- The BCOP test identified the test substance as not corrosive or severe irritant based on a mean IVIS of 3.3.
- 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.
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 mean IVIS of 3.3 of the test substance treated corneas did not indicate a corrosive or severe
eye irritation potential.
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