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EC number: 821-451-7 | CAS number: 78920-10-2
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Aug 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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017
- Deviations:
- no
- 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:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-hydroxy-4-propyl-2,5-dihydrofuran-2-one
- Cas Number:
- 78920-10-2
- Molecular formula:
- C7H10O3
- IUPAC Name:
- 5-hydroxy-4-propyl-2,5-dihydrofuran-2-one
- Test material form:
- liquid: viscous
- Details on test material:
- - Appearance: Brown viscous liquid
- Storage condition of test material: At room temperature
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL: 750 µL per cornea
POSITIVE CONTROL: 750 µL Ethanol per cornea
NEGATIVE CONTROL: 750 µL of physiological saline per cornea - Duration of treatment / exposure:
- 10 minutes (at 32°C)
- Duration of post- treatment incubation (in vitro):
- 120 minutes (at 32°C)
- Number of animals or in vitro replicates:
- 3 corneas for each treatment group
- Details on study design:
- SELECTION, PREPARATION AND QUALITY CHECK OF CORNEAS
- Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Corneas with those exhibiting defects were discarded.
- The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine (Life Technologies) and 1% (v/v) Foetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 ± 1°. The corneas were incubated for the minimum of 1 hour at 32 ± 1°C.
- After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer (BASF-OP3.0, BASF, Ludwigshafen, Germany). The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used. Three corneas were selected at random for each treatment group.
TREATMENT
The medium from the anterior compartment was removed and 750 µL of either the negative control, positive control or test item was introduced onto the epithelium of the cornea. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the control or the test item over the entire cornea.
REMOVAL OF TEST SUBSTANCE
The corneas were rinsed until no color change of the medium was observed anymore, as a pH effect of the test substance was observed on the rinsing medium.
POST-TREATMENT
The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently the corneas were incubated. After the completion of the incubation period opacity determination was performed. Each cornea was inspected visually for dissimilar opacity patterns.
OPACITY
The opacity of a cornea was measured by the diminution of light passing through the cornea. The change in opacity for each individual cornea was calculated, by subtracting opacity before treatment from opacity after post-treament. Subsequently negative control corrected. The mean opacity value of each treatment group was calculated by averaging the corrected opacity values of the treated corneas for each treatment group.
PERMEABILITY
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Sigma-Aldrich, Germany) was evaluated. The medium of both compartments (anterior compartment first) was removed. The posterior compartment was refilled with fresh cMEM. The anterior compartment was filled with 1 mL of 4 mg Na-fluorescein (Sigma-Aldrich Chemie GmbH, Germany)/mL cMEM solution. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the sodium-fluorescein solution over the entire cornea. Corneas were incubated in a horizontal position for 90 ± 5 minutes at 32 ± 1°C.
- After the incubation period, the medium in the posterior compartment of each holder was removed and placed into a sampling tube labelled according to holder number. 360 µL of the medium from each sampling tube was transferred to a 96-well plate. The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader (TECAN Infinite® M200 Pro Plate Reader). Any OD490 that was 1.500 or higher was diluted to bring the OD490 into the acceptable range (linearity up to OD490 of 1.500 was verified before the start of the experiment). OD490 values of less than 1.500 were used in the permeability calculation.
- The mean OD490 for each treatment was calculated using cMEM corrected OD490 values.
SCORING SYSTEM
In Vitro Irritancy Score (IVIS) = mean opacity value + (15 x mean OD490 value)
DECISION CRITERIA
- A test substance that induces a mean IVIS >55 is classified with Eye Irr. Cat. 1 in accordance with the CLP Regulation
- A test substance that induces a mean IVIS ≤ 3 is not classified for Eye irritation/corrosion in accordance with the CLP Regulation
- For a test substance that induces a mean IVIS of >3 - ≤55, no prediction on the classification can be made. More information is needed.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3
- Value:
- 134
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Historical Control Data (period: May 2015 to May 2018):
Negative control Positive control
Opacity Permeability In vitro Irritancy Score In vitro Irritancy Score
Range -2.9 – 3.0 -0.034 – 0.100 -2.8 – 3.0 28.0 – 110.9
Mean 0.25 0.00 0.31 55.03
SD 1.13 0.01 1.19 15.08
n 118 118 118 94
Any other information on results incl. tables
Summary of results:
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score |
Negative control |
2.5 |
0.012 |
2.7 |
Positive control |
20 |
3.377 |
71 |
Test substance |
66 |
4.525 |
134 |
Individual in vitro irritancy scores:
Treatment |
In vitro Irritancy Score |
Negative control |
1.9 |
3.5 |
|
2.7 |
|
Positive control |
66 |
78 |
|
68 |
|
Test substance |
131 |
144 |
|
127 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on GHS and CLP criteria
- Conclusions:
- Based on a mean in vitro irritancy score of 134 in a Bovine Corneal Opacity and Permeability test, it is concluded that the substance needs to be classified with Category 1 (irreversible effects on the eye) based on GHS and CLP criteria.
- Executive summary:
Using the Bovine Corneal Opacity and Permeability test (BCOP test) the substance was screened for its eye irritancy potential in accordance with OECD 437 and according to GLP principles. The liquid substance was applied as such on the corneas. Adequate negative and positive controls were included. The mean in vitro irritancy score was 134 and the acceptance criteria were met. Since the substance induced a mean IVIS >55, the substance needs to be classified for eye irritation/corrosion with Eye Irr. Cat. 1 in accordance with the CLP Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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