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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:
1983
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1959
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: not specified
- Age at study initiation: not specified
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: single cages
- Diet: standard laboratory diet for rabbits (Altromin, Lage)
- Water: e.g. ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Observation period (in vivo):
1, 2, 4, 8, 24, 48, 72 and 96 hours until day 7
Number of animals or in vitro replicates:
5
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. After 24 h these irritaitions were fully reversible. In the iris and cornea no changes could be detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to the eye.
Executive summary:

The potential of the test substance to cause eye irritation was tested in five rabbits according to OEDC 404 and GLP. The animals were treated with 0.1 mL test substance and observed for 7 days. The mean score for cornea opacity and iris were 0 for 24/48/72 h. Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. The conjunctivae score was 0 for 24/48/72 h. All effects observed were reversible within 24 h. Due to these results the test substance was found to be not irritating for the eye.