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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable 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
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

Constituent 1
Chemical structure
Reference substance name:
4-chlorobenzaldehyde
EC Number:
203-247-4
EC Name:
4-chlorobenzaldehyde
Cas Number:
104-88-1
Molecular formula:
C7H5ClO
IUPAC Name:
4-chlorobenzaldehyde
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:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.22
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
see "any other information on results incl. tables"

Any other information on results incl. tables

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:
Category 2 (irritating to eyes) based on GHS criteria
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).

The substance is classified as irritating (Cat. 2) according to GHS.