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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-10-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study on analogue substance used. Consistent with standard methodology at the time although prior to GLP Principles.
Justification for type of information:
Study on analogue substance used. Consistent with standard methodology at the time although prior to GLP Principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
2018

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited description but close to standard test method
GLP compliance:
no
Remarks:
prior to standar test method

Test material

Constituent 1
Chemical structure
Reference substance name:
4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
EC Number:
205-271-0
EC Name:
4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
Cas Number:
136-99-2
Molecular formula:
C16H32N2O
IUPAC Name:
4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
Test material form:
solid: crystalline
Details on test material:
- State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles:
- Crystal structure:
- Coating:
- Surface properties:
- Density:
- Moisture content:
- Residual solvent:
- Activation:
- Stabilisation:
- Other:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in a cool, dry and well ventilated place and away from foodstuffs. In darkness at room temperature.
- Stability under test conditions: Yes
- Solubility and stability of the test substance in the solvent/vehicle: Slighthly soluble in water 33.9 mg/L
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Reacts with strong acids

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

Remark: Environmental precautions: Do not allow to enter drains or waterways.
Do not discharge into the subsoil/soil

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): as is

VEHICLE
no vehicle used
Duration of treatment / exposure:
The test material was instilled into the right eye, with no further treatment.
Observation period (in vivo):
The eyes were examined every 24 hours for 4 days and then again on the 7th day.
Duration of post- treatment incubation (in vitro):
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
time point: 24-48-72 hrs
Value:
4
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: Reversibility: No reversibility observed up to d7. All 3 animals displayed the highest score.
Irritation parameter:
other: iris score
Run / experiment:
Time point: 24-48-72 hrs
Value:
2
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: Reversibility: No reversibility observed up to d7. All 3 animals displayed the highest score.
Irritation parameter:
other: Conjunctivia score
Run / experiment:
Time point: 24-48-72 hrs
Value:
3
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: Reversibility: No reversibility observed up to d7. All 3 animals displayed the highest score.
Irritation parameter:
other: Chemosis score
Run / experiment:
Time point: 24-48-72 hrs
Value:
4
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: Reversibility: No reversibility observed up to d7. All 3 animals displayed the highest score.
Irritation parameter:
other: discharge
Run / experiment:
Time point: observation period
Value:
110
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: Reversibility: No reversibility observed up to d7. All 3 animals displayed the highest score.

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(individual Mean for 24-48-72 h
Basis:
other: animal #1, #2, #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: No reversibility observed up to d7
Remarks on result:
other: All 3 animals displayed the highest score.
Irritation parameter:
iris score
Remarks:
(individual Mean for 24-48-72 h)
Basis:
other: animal #1, #2, #3.
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: No reversibility was observed up to d7
Remarks on result:
other: All 3 animals displayed the highest score.
Irritation parameter:
conjunctivae score
Remarks:
(ind(Invidual mean: for 24-48-72 hr)
Basis:
other: animal #1, #2, #3.
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: No reversibility observed up to d7
Remarks on result:
other: All 3 animals displayed the highest score.
Irritation parameter:
chemosis score
Remarks:
(individual Mean for 24-48-72 hrs)
Basis:
other: animal #1, #2, #3.
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: No reversibility was observed up to d7
Remarks on result:
other: All 3 animals displayed the highest score.
Irritation parameter:
other: discharge
Basis:
other: animal #1, #2, #3
Time point:
other: Observation period
Score:
3
Max. score:
3
Reversibility:
other: No reversibility observed up to d7
Remarks on result:
other: All 3 animals displayed the highest score.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
other: animal #1, #2, #3
Time point:
other: for each time point
Score:
110
Max. score:
110
Reversibility:
other: No reversibility observed up to d7
Remarks on result:
other: MMTS for each animal
Irritant / corrosive response data:
All 3 animals displayed the maximal scores for each parameter and over the whole observation period (7 days). The corneal opacity involved the the whole area.
The observation period stopped on day 7 without any decrease in the intensity of the effects.
Other effects:
- Lesions and clinical observations: No data
- Ophthalmoscopic findings: No data
- Histopathological findings: No data
- Effects of rinsing or washing: No data
- Other observations: None

Any other information on results incl. tables

All 3 animals displayed the maximal scores for each parameter and over the whole observation period (7 days). The corneal opacity involved the the whole area.

The observation period stopped on day 7 without any decrease in the intensity of the effects.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Remarks: Migrated information (Risk of serious damage to the eyes) Criteria used for interpretation of results: EU
Conclusions:
Severe effects to the eyes.
Executive summary:

A test to determine the potential for eye irritation was conducted using three albino rabbits. Each animal was administered 0.1 ml of the test material to one eye with the other eye serving as a negative control. Observations were recorded at 24, 48, and 72 hours and again at 4 and 7 days.  

The test substance induced severe damages to the eyes (maximum scores observed in all the animals for each of the parameters).

The test substance is considered to be an extreme irritant to rabbit eyes under the test conditions.