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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:
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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
according to OECD parinciples

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): O-Chlorbenzaldehyd D

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
 day 2  3  1  1  1  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
 day 4  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  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  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
 day 5            0
 AREA OF OPACITY            
 day 1 (1 hour)  0  0  0  0  0  0
 day 2  2  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).