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Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jan 2019
- 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 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
- Remarks:
- aquous solution
- Details on test material:
- Sodium salts of substituted amino acid (2) solution, FC-C 13588
Appearance: clear colorless solution
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse Vitelco, 's-Hertogenbosch, The Netherlands.
- Storage, temperature, and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, 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. Those exhibiting defects were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL - Duration of treatment / exposure:
- 10 ± 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 minutes in cMEM for opacity measurements and subsequently 90 ± 5 minutes in sodium-fluorescein for permeability determinations
- Number of animals or in vitro replicates:
- 3 replicates for the negative, positive, and treatment group each.
- Details on study design:
- TREATMENT METHOD:
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.
Corneas were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red (Earle’s Minimum Essential Medium, Life Technologies) and thereafter with cMEM. Possible pH effects of the test item on the corneas were recorded.
- POST-EXPOSURE INCUBATION: 120 ± 10 minutes in cMEM for opacity measurements and subsequently 90 ± 5 minutes in sodium-fluorescein for permeability determinations
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microplate reader (TECAN Infinite® M200 Pro Plate Reader). OD490 values of less than 1.500 were used in the permeability calculation.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score: In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
ACCEPTABILITY CRITERIA
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
DECISION CRITERIA: (see table 1):
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤ 55, no prediction on irritant potency can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 replicates
- Value:
- 0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Mean IVIS: 1.4
- Positive controls validity:
- valid
- Remarks:
- Mean IVIS: 49
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - The corneas treated with the test item showed opacity values of: -0.7, 0.6, 1.1 (corrected for negative control)
- Permeability values were: 0.010, 0.070, 0.014 (corrected for negative control)
- Individual IVIS scores were: -0.6, 1.7, 1.3
OTHER EFFECTS:
- The corneas were clear after the 10 minutes of treatment with the test item.
- A pH effect of the test item was observed on the rinsing medium
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within historical range (IVIS ranging from 0.7 to 1.8).
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 37 to 63).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A Bovine Corneal Opacity and Permeability test (BCOP) was performed according to OECD guideline 437 and GLP principles. Sodium salts of substituted amino acid (2) solution induced an IVIS ≤ 3, therefore no classification is required for eye irritation or serious eye damage.
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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