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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
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

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, U.K.
- Age at study initiation: approximately 12-16 weeks old
- Weight at study initiation: 2.51-2.80 kg
- Housing: individually, in suspended metal cages
- Diet: Rabbit Diet (AW Tindall Limited, Holbeach, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-20 °C
- Humidity: 60-68 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 08-Oct-1985 To: 11-Oct-1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted
Duration of treatment / exposure:
Single intraocular application
Observation period (in vivo):
72 hours (terminated as no reactions were apparent)
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
SCORING SYSTEM: Draize (1959) scale for scoring ocular irritation. Using the numerical data obtained a modified version of the system described by Kay & Calandra (1962) was used to classify the ocular irritation potential of the test material.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1 hour
Score:
13
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1 hour
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 1 hour
Score:
11
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
10
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: group mean score
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24 hours
Score:
4
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 24 hours
Score:
2
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
110
Remarks on result:
other: group mean score
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 48 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 48 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 48 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
110
Remarks on result:
other: group mean score
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 72 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 hours
Score:
0
Max. score:
110
Remarks on result:
other: total score for conjunctivae, iris and cornea
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
110
Remarks on result:
other: group mean score

Any other information on results incl. tables

No evidence of corneal damage was noted throughout the 72-hour study period. Iridial inflammation was apparent in 2/3 rabbits at the 1-hour reading only. Slight conjunctivitis identified by redness (grade 2) and swelling (grades 1-2) was noted in 3/3 rabbits at the 1-hour reading. The reactions had resolved completely by the 24-hour (1/3 rabbits) or the 48-hour observation (2/3 rabbits). In addition, 0/3 rabbits showed evidence of positive ocular irritation.

Applicant's summary and conclusion

Executive summary:

In a primary eye irritation study (Jones & Collier, 1985), 0.1 mL of undiluted ZD 8 Gewaschen was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. Animals then were observed for 72 hours following treatment. Irritation was scored by the method of Draize (1959) and the test item was classified for its ocular irritation potential according to Kay & Calandra (1962, modified). The treatment resulted in a maximum mean score of 10 and the test item was classified as a minimal irritant (class 3 on a scale of 1 to 8).

In this study, ZD 8 Gewaschen was a minimal irritant to the rabbit eye.