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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:
1 June 1987 to 5 June 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

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

Test material

Constituent 1
Test material form:
liquid: viscous
Details on test material:
- Appearance: amber-coloured, slightly viscous liquid
- Storage conditions: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK and David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: ca. 12 - 16 weeks
- Weight at study initiation: 2.36 - 3.32 kg
- Housing: Individually housed in suspended metal cages
- Diet: ad libitum (Rabbit Diet, Preston Farmers Ltd., New Leake, Lincolnshire)
- Water: ad libitum
- Acclimation period: 5 days (minimum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21 °C
- Humidity (%): 65 - 68 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL test material was instilled into the in the conjunctival sac of the right eye of each rabbit by gently pulling the lower lid away from the eyeball. The lids were then gently held together for ca. 1 second to prevent loss of the test material. The other eye remained untreated and served as the control.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eys of each animal were examined 1, 24, 48 amd 72 hours after instillation of the test material.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: The irritation reactions were scored using the Draize System.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light sourced from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No adverse corneal effects were noted in any treated eye during the observation period.
Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment.
Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study the test material was not found to be irritating to the eyes.
Executive summary:

The potential of the test material to cause eye irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 405.

During the study single samples of test material (0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test material resulted in no adverse corneal effects in any treated eye during the observation period. Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment. Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.

Based on the results of this study, the test material is not considered to be an eye irritant.