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EC number: 926-197-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22-jun-2015 to 23-jun-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Referenceopen allclose all
- Reference Type:
- other: study amendment
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 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”
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.47 “Bovine corneal opacity and permeability method for identifying ocular corrosives and severe irritants
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-[(S)-4-Carboxy-4-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-butyrylamino]-2-nitro-benzoic acid
- EC Number:
- 926-197-1
- Cas Number:
- 2561176-48-3
- Molecular formula:
- C20 H15 N3 O9
- IUPAC Name:
- 5-[(S)-4-Carboxy-4-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-butyrylamino]-2-nitro-benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): P-Glupa-C
- Substance type: Yellow powder
- Physical state: solid
- Storage condition of test material: At room temperature
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 357.1 to 374.1 mg per cornea
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole
- Duration of treatment / exposure:
- 240 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- 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).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
In vitro score range UN GHS
= 3 No Category
> 3; = 55 No prediction can be made
>55 Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 58.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category I
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since P-Glupa-C induced an IVIS = 55, it is concluded that P-Glupa-C induces serious eye damage in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report and should be classified category 1 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
- Executive summary:
The negative control responses of physiological saline for opacity and permeability (0.0 and 0.000, respectively) were less than the upper limits of the laboratory historical range (2 and 0.050, respectively) indicating that the negative control did not induce irritancy on the corneas.The meanin vitroirritancy score of the positive control (20% (w/v) Imidazole) was 154 just above the current historical positive control mean plus two standard deviations.It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
P-Glupa-C induced serious eye damage through both endpoints, resulting in a meanin vitroirritancy score of 59 after 240 minutes of treatment.
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