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EC number: 201-956-3 | CAS number: 89-98-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- according to OECD parinciples
Test material
- Reference substance name:
- 2-chlorobenzaldehyde
- EC Number:
- 201-956-3
- EC Name:
- 2-chlorobenzaldehyde
- Cas Number:
- 89-98-5
- Molecular formula:
- C7H5ClO
- IUPAC Name:
- 2-chlorobenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): O-Chlorbenzaldehyd D
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- strain: Hy/Cr
- Source: Charles River France (Saint Aubin les Elbeuf, France)
- Weight at study initiation: mean weight on the day of treatment: 2408 g
- Housing: individually in polystyrene cages
- Diet: pelleted Rabbit Diet SOC, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50% +/- 30%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
- preventive treatment for coccidiosis by application of Mucoxid via drinking water
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 4 days following the day of treatment
- Number of animals or in vitro replicates:
- 6
- Details on study design:
-
SCORING SYSTEM:
CONJUNCTIVAE
Redness
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2*
Diffuse beefy red 3*
Chemosis
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half closed 3*
Swelling with lids more than, half closed 4*
Discharge
Absence of discharge 0
Slight discharge (does not include small amounts normally found in inner canthus) 1
Discharge with moistening of lids and hairs adjacent to lids 2
Discharge with moistening of lids and hairs on considerable area around the eye 3
IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia, or injection, any of these or
combination of any thereof, iris still reacting to light
(sluggish reaction is positive) 1*
No reaction to light, haemorrhage, gross destruction
(any or all of these) 2*
CORNEA
Opacity : degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling
or normal lustre), details of Iris clearly obscured 1*
Easily discernible translucent area, details of iris slightly obscure 2*
Nacrous area, no details of Iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*
Area of opacity
One quarter (or less) but not zero 1
Greater than one quarter but less than a half 2
Greater than one half but less than three quarters 3
Greater than three quarters up to whole area 4
* starred figures indicate positive effect
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- #3 / #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- #4 / #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- iris score
- Remarks:
- degree of congestion
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.39
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Remarks:
- degree of congestion
- Basis:
- animal #1
- Remarks:
- #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- iris score
- Remarks:
- degree of congestion
- Basis:
- animal #2
- Remarks:
- #3 / #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Remarks:
- degree of congestion
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: degree if opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- #3 / #4 / #4 / #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritant / corrosive response data:
- Chemosis and redness of the conjunctivae were observed in all animals on day 1, 2, and 3. This effect was reversible in 5 animals on day 4 and in all animals on day 5.
Conjunctivae discharge occurred in 3 animals one hour after application, it was still observable in 2 animals on day 2 and in one animal on day 3, but was fully reversible in all animals on day 4.
Congestion of the iris was seen in 3 animals on day 2 and 3 and persisted in one animal till day 4. The effect was fully reversible in all animals on day 5.
Opacity of the cornea was observed in one animal on day 2 and day 3, but was fully reversible on day 4.
Any other information on results incl. tables
Eye irritation evaluation
CONJUNCTIVAE
| day of observation | Animal No | |||||
| CHEMOSIS | 01 | 02 | 03 | 04 | 05 | 06 |
| day 1 (1 hour) | 2 | 2 | 2 | 2 | 2 | 2 |
| day 2 | 3 | 1 | 1 | 1 | 2 | 2 |
| day 3 | 2 | 1 | 1 | 1 | 2 | 2 |
| day 4 | 0 | 0 | 0 | 0 | 0 | 2 |
| day 5 | 0 | |||||
| DISCHARGE | ||||||
| day 1 (1 hour) | 1 | 1 | 0 | 0 | 0 | 1 |
| day 2 | 2 | 1 | 0 | 0 | 0 | 0 |
| day 3 | 1 | 0 | 0 | 0 | 0 | 0 |
| day 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| day 5 | 0 | |||||
| REDNESS | ||||||
| day 1 (1 hour) | 2 | 2 | 2 | 2 | 2 | 2 |
| day 2 | 2 | 2 | 1 | 1 | 1 | 2 |
| day 3 | 2 | 0 | 1 | 1 | 1 | 2 |
| day 4 | 0 | 0 | 0 | 0 | 0 | 2 |
| day 5 | 0 | |||||
| day of observation | Animal No | |||||
| IRIS | 01 | 02 | 03 | 04 | 05 | 06 |
| DEGREE OF CONGESTION | ||||||
| day 1 (1 hour) | 0 | 0 | 0 | 0 | 0 | 0 |
| day 2 | 1 | 0 | 0 | 0 | 1 | 1 |
| day 3 | 1 | 0 | 0 | 0 | 1 | 1 |
| day 4 | 0 | 0 | 0 | 0 | 0 | 1 |
| day 5 | 0 | |||||
| CORNEA | ||||||
| DEGREE OF OPACITY | ||||||
| day 1 (1 hour) | 0 | 0 | 0 | 0 | 0 | 0 |
| day 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| day 3 | 1 | 0 | 0 | 0 | 0 | 0 |
| day 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| day 5 | 0 | |||||
| AREA OF OPACITY | ||||||
| day 1 (1 hour) | 0 | 0 | 0 | 0 | 0 | 0 |
| day 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| day 3 | 2 | 0 | 0 | 0 | 0 | 0 |
| day 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| day 5 | 0 | |||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information conclusion of the study director Criteria used for interpretation of results: EU
- Conclusions:
- Based on the study results, 2-chlorobenzaldehyde was not irritating to the eye.
- Executive summary:
Eye irritation of 2-chlorobenzaldehyde has been investigated in New Zealand rabbits. In a study according to OECD TG 405 chemosis and redness for all animals, and discharge for three animals were observed on day 1. Congestion of iris for three animals and an opacity of cornea for one animal were observed on day 2. These reactions regressed from day 3 until day 5 and were fully reversible at the end of the observation period (day 5 post application).
This well performed study, which is in accordance with existing guidelines, has been selected as key study (RL1).
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