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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:
From 4 MAR 1985 to 11 MAR 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: initial body weights of the test animals differ slightly to much
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.24 to 2.87 kg
- Housing: suspended metal cages, individually
- Diet: standard laboratory diet (Rabbit Diet, A .W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-61
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The treated and control eyes the animals remained unwashed throughout the observation period.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: basically according to guideline OECD 405

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)

Reeding times: 1, 24, 48 and 72 hours following treatment (if irritation persisted at the 72 h observation additional readings were made at 7, 14 and 21 days)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
of all animals; individual scores per animal: 1/0.33/1
Time point:
other: 24-48-72 h
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all animals; individual scores per animal: 1/0/1
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Observations at reading times (scores are given for animal#1/#2/#3) :
- 1h: diffuse crimson red colouration of the conjunctivae accompanied by slight swelling in all three animals (conjuctivae redness 2/2/2; chemosis 2/2/2; discharge 2/2/2; all other scores in all animals are 0)
- 24 h: reduction in the level of reaction in all three animals (conjuctivae redness 1/1/1; chemosis 1/0/1; discharge 0/0/0; all other scores in all animals are 0)
- 48 h: the reactions had already ameliorated completely in one rabbit (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 72 h: (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 7 days: the remaining two rabbits are fully recovered (all scores are 0)

Any other information on results incl. tables

Read-across justification: for details please see read-across report in IUCLID section 13

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions tested the test item is not irritating to eyes of rabbits.
Executive summary:

Irritation of the eye was tested in 3 New Zealand white rabbits according to guideline OECD 405. 0.1 mL of test item (purity: not stated, undiluted, not washed out) were instilled into the lower conjunctival sac of the right eye of each rabbit. At relevant reading times (24, 48 and 72 h after test material instillation) slight irritating effects on the conjunctiva (redness (mean score: 0.78; indivial scores per animal: 1/0.33/1)) and chemosis (mean score: 0.67; individual ) were observed in all animals. All effects were fully reversible within 7 days and no effects on the cornea or iris were observed, thus the test item is not irritating to the eye.

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity.