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Diss Factsheets

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:
September 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-130-7
EC Name:
-
Cas Number:
106246-33-7
Molecular formula:
C21 H28 Cl2 N2
IUPAC Name:
4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline
Details on test material:
- Substance code: P5367
- Batch No.: 1/86
- Appearance: Brown solidified melt
- Storage: At ambient temperature in the dark
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Two males and one female
- Source: Cheshire Rabbit Farms Ltd.
- Weight at study initiation: 2.5 - 3 kg
- Housing: individually in aluminium cages
- Diet: Special Diet Services Expanded Rabbit Diet
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 21°C
- Humidity: mean 58%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 s. The other eye remained untreated to serve as a control.
Observation period (in vivo):
Observations were done 1, 24, 48 and 72 hours after treatment
Number of animals or in vitro replicates:
3 (2 males & 1 female)
Details on study design:
Approximately 24 h before test commencement, both eyes of each rabbit were examined for defects. The quantity of material instilled into each treated eye was 100 mg. Instillation of the test material was by the following technique: The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 s. The other eye remained untreated to serve as a control.The eyes were examined for irritation using standard illumination. The ocular reaction was recorded at 1, 24, 48 and 72 h after
instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.23
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks:
score 1 observed in two animals at 24h observation time
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks:
score 1 observed in one animal one hour after treatment
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
Conjunctival redness, chemosis and discharge were recorded at 1 hour (maximum score was 2 in two animals). By 48 hours all treated eyes were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be non-irritating to rabbit seyes.
Executive summary:

The study was performed 1986 as GLP-test following EC-test method B.5. The used species were New Zealand White rabbits; 100 mg test item was instilled in the conjunctival sac of two males and one female. Conjunctival irritation was limited to slight redness and chemosis (score 1) in 1/3 rabbits and moderate redness, chemosis and discharge (score 2) in 2/3 rabbits at 1 h post instillation. After 24 h, slight redness persisted in 2/3 rabbits. By 48 h all treated eyes were normal. In conclusion, P5367 is not irritant to rabbit eyes.