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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature
Specific details on test material used for the study:
- Lot/batch No.: 057249.28
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410 - 2660 g
- Housing: individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau / Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: 5 days (23 June, 1983 - 27 June, 1983)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
see observation period (no washing conducted)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not done

SCORING SYSTEM: according to OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal 1 -3)
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 24 - 48 h
Remarks on result:
other: see table below for details
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
other: see table below for details
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
24/48/72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 24 - 48 h
Remarks on result:
other: see table below for details
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 - 72 h
Remarks on result:
other: see table below for details
Other effects:
The body weight development was not affected by the application of the test article. No other reactions to treatment were recorded during the whole observation period.

Any other information on results incl. tables

Table 1: Evaluation of the eye reactions

Animal  Reading  Cornea Opacity Iris Conjunctiva
Redness Chemosis
1 1 h 0 0 0 0
2 1 h 1 0 1 0
3 1 h 1 0 2 1
1 24 hrs 0 0 0 1
2 24 hrs 0 0 0 0
3 24 hrs 1 0 1 1
1 48 hrs 0 0 0 0
2 48 hrs 0 0 0 0
3 48 hrs 0 0 0 1
1 72 hrs 0 0 0 0
2 72 hrs 0 0 0 0
3 72 hrs 0 0 0 0
1 7 days 0 0 0 0
2 7 days 0 0 0 0
3 7 days 0 0 0 0
1 24/48/72 hrs 0 0 0 0.3
2 24/48/72 hrs 0 0 0 0
3 24/48/72 hrs 0.3 0 0.3 0.7
mean animal 1-3 24/48/72 hrs 0.1 0.0 0.1 0.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met