Registration Dossier

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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no 1 hour reading, observation period only 8 days
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : p-Chlorobenzaldehyde

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: W. Ostrup / Meerbuch
- Weight at study initiation: average 2.4 kg
- Diet (ad libitum): mümmel z (ssniff / Soest)
- Water (ad libitum): yes
- Acclimation period: 7- 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- 100 µl bulk volume of the crystalline substance
Duration of treatment / exposure:
see "details on study design"
Observation period (in vivo):
- 8 days
- reading after 24, 48 and 72 hours and after 8 days
Number of animals or in vitro replicates:
6
Details on study design:
After one single application of 100 µl of the test item into the right eye (conjunctival sac) of the animal the eyelid was closed for 1 second, and the
eye was not washed out after application.
The left eye stayed untreated serving as a control.

Scoring system:According to Draize

Tool used to assess score: ophthalmoscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
10
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
5.8
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
1.6
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
5
Max. score:
10
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
2.5
Max. score:
10
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
2.5
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
13.7
Max. score:
20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
8
Max. score:
20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
5.7
Max. score:
20
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
over 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
18.3
Max. score:
110
Remarks on result:
other: Classifiaction: slightly irritating
Irritant / corrosive response data:
see "any other information on results incl. tables"

Any other information on results incl. tables

animal #

cornea

iris

conjunctiva

chemosis

 

score*

reversiblity**

score*

reversiblity**

score*

reversiblity**

score*

reversiblity**

1

1

yes

1

yes

2.33

yes

1.33

yes

2

0.67

yes

1

no

1.67

yes

1.0

yes

3

0.67

yes

1

no

1.33

yes

1.33

yes

4

0.67

yes

0.33

yes

1.33

no

0.67

yes

5

0.67

yes

0.33

yes

3.22

no

2.0

no

6

1

yes

0.33

yes

1.33

no

1.0

yes

* mean of scores at the 24, 48 and 72 h reading

** full reversibility within the 8-d observation period

The signs of irritation which were still present in some animals at the end of the 8 -d observation period were less severe than after 72 h.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Executive summary:

In an eye irritation study (FhG, 1980) New Zealand white rabbits (6 animals) were exposed to 0.1 mL of p-Chlorobenzaldehyde (pure). The animals then was observed for 8 days. Irritation was scored after 24, 48 and 72 hours by the method of Draize. The substance revealed slight eye irritating effects in rabbits (primary eye irritation index = 18.3). The irritating signs were reversible at the end of the observation period (8 days) in 2/6 animals, but still present (less severe) in 4/6 rabbits, indicating a full reversibility if the test would have been performed with an observation period of 21 days (acc. to OECD GL 405).