Registration Dossier
Registration Dossier
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EC number: 942-380-9 | CAS number: 131796-64-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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 (incl. QA statement)
Test material
- Reference substance name:
- 2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate
- EC Number:
- 942-380-9
- Cas Number:
- 131796-64-0
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ZH 291 A1 Fr.2-4
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Source of collected eyes:
- Source: Schlachthof Mannheim, Schlachthofstr. 21, 68165 Mannheim, Germany
- Age at study initiation: > 12 months and < 60 months
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 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 (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagle’s MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the equilibration period the medium in both chambers was replaced with fresh pre-warmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that showed macroscopic tissue damage or an opacity value < 548 opacity units were discarded.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
yes, 750 µLwater
POSITIVE CONTROL USED
yes, 750 µL ethanol (PC1), 750 µL dimethylformamide (PC2)
APPLICATION DOSE AND EXPOSURE TIME
750 µL, 10 min
POST-INCUBATION PERIOD:
no
REMOVAL OF TEST SUBSTANCE
Number of washing steps after exposure period: at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red).
POST-EXPOSURE INCUBATION:
2 h
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: The optical density (OD490) of passaged sodium fluorescein dye was determined with the aid of a SunriseTM Absorbance Reader.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
Evaluation of the test results based on to the criteria given in OECD 437 (July 2013).
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 1.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Test substance identification |
Mean Opacity Value |
Mean Permeability Value |
Mean In Vitro Irritacy Score |
Test substance |
1.5 |
0.003 |
1.6 |
NC |
5.7 |
0.005 |
5.8 |
PC1 (Ethanol) |
25.6 |
0.610 |
34.7 |
PC2 (DMF) |
105.7 |
0.472 |
112.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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