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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:
other: well-documented scientifically fully acceptable, non-GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Dipropoxy-p-toluidin

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Diet : ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60 %
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 µL






Duration of treatment / exposure:
24h
Observation period (in vivo):
1h, 24h, 48h, 72 h, 7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): NaCl solution
- Time after start of exposure: 24 h
- Procedure:Test material was placed in the conjunctival sac of one eye each animal. The lids are then gently held together for about one second in order to prevent loss of the material.

SCORING SYSTEM: Draize Evaluation for eye irritation (according to OECD guideline 405)

TOOL USED TO ASSESS SCORE: optical device, eyes were further examined with the aid of fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 72h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks:
within 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks:
within 72h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 72h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks:
within 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 72h
Other effects:
Lacrimation was observed in all animals at the 1h reading and in 2/3 animals at the 24h reading.

Applicant's summary and conclusion

Conclusions:
The test substance caused eye irritation after application into conjunctival sac of the rabbit eye.