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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:
11 - 18 Aug 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfaune UK Ltd.
- Age at study initiation: adult
- Weight at study initiation: 3.4kg
- Housing: one animal/cage (type III)
- Diet (e.g. ad libitum): "ssniff K4", ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): bulk volume of 100µL (approx. 40mg test substance) of the test substance applied, eye closed for 1sec
Duration of treatment / exposure:
24 h exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein after 24h, UV-light

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:
animal: 1;2;3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak 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

Any other information on results incl. tables

endpoint average score per observation time and endpoint
24h 48h 72h
cornea opacity 0.0 0.0 0.0
iris value 0.0 0.0 0.0
conjuctiva redness 1.0 1.0 0.0
chemosis 0.0 0.0 0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not cause any significant signs of irritation in rabbit eyes. Slight conjunctivae redness in 3/3 animals was fully reversible within 72 h. The substance is not classifiable according to CLP criteria.