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EC number: 943-368-6 | CAS number: -
- Life Cycle description
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- Endpoint summary
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oxidation products of D-Glucose with nitric acid, sodium salts
- Molecular formula:
- Reaction products consisting mainly of sodium salts of D-glucarate, mono, di and tri carboxylic acids and keto gluconates. See remarks
- IUPAC Name:
- Oxidation products of D-Glucose with nitric acid, sodium salts
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Isolated bovine cornea obtained from freshly slaughtered animals, age 12-48 months. Whole eyes were transported to the test facility in HBSS on ice. The eyes were carefully examined for pre-existing defects and used within 12 hours of collection.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL, undiluted
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 5 (negative control), 3 (test material) or 4 (positive control) replicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Isolated bovine cornea obtained from freshly slaughtered animals, age 12-48 months. Whole eyes were transported to the test facility in HBSS on ice.
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were carefully examined for pre-existing defects and used within 12 hours of collection.
NUMBER OF REPLICATES
5 (negative control), 3 (test material) or 4 (positve control) replicates
NEGATIVE CONTROL USED
Water for irrigation
POSITIVE CONTROL USED
Ethanol
APPLICATION DOSE AND EXPOSURE TIME
0.75 mL; 10 minutes
TREATMENT METHOD
Closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
- POST-EXPOSURE INCUBATION
2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: illuminance
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
- Other: visual observation
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean IVIS from three replicates
- Value:
- 2.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean IVIS 38.45
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
In vivo
- Other effects:
- None observed
Any other information on results incl. tables
Test material | Mean IVIS 2.3 |
Positive control | Mean IVIS 38.45 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on a mean IVIS score of 2.3, the test material [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts] does not require classification for serious eye damage or eye irritation according to the CLP Regulation.
- Executive summary:
The potential of the test material [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts] to cause serious eye damage was assessed in a BCOP assay (closed chamber method) performed to OECD 437. 0.75 mL of the test material was applied to the cornea (three replicates) for 10 minutes, followed by a 2-hour post-exposure incubation period. Corneal opacity was measured; corneal permeability was assessed using sodium fluorescein solution and measurement of absorption at 490 nm and IVIS scores calculated. Isolated corneas were also exposed in parallel to negative control (water) and positive control (ethanol) substances. A mean IVIS score of 2.3 was calculated for the test material, indicating that it does not require classification for serious eye damage or eye irritation according to the CLP Regulation. Responses to the negative and positive controls confirmed the integrity and sensitivity of the assay.
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