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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:
4 November 1985 to 11 November 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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)
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
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: by Nottingham UnÍversity, School of Agriculture, Sutton BonÍngton, Leicestershire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.54-3.12 kg
- Housing: individually
- Diet: Rabbit Diet, A.l.l. Tindall Limited, Holbeach, Lincolnshire UK ad libitum
- Water:. ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C
- Humidity (%): 45-55%
- Air changes (per hr): ca 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL (48 mg)
Observation period (in vivo):
at 1, 24, 48, 72 hours and at day 7 (one rabbit only)
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:Draize

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)

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:
0
Remarks on result:
no indication of irritation
Remarks:
at the 1 hour observation dulling of the cornea was observed in all 3 rabbits
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
2
Reversibility:
fully reversible
Remarks:
one animal reversible within 7 days others within 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritation observed
Other effects:
at the 1 hour observation dulling of the cornea was seen and areas of yellow staining

Any other information on results incl. tables

Animal no 1 2 3
1 24 48 72 7 1 24 48 72 1 24 48 72
cornea  D 0 0 0 0 D 0 0 0 D 0 0 0
iris 1 0 0 0 0 1 0 0 0 1 0 0 0
conjunctivae                          
redness 2 2 1 1 0 1 1 1 0 2 1 1 0
chemosis 2 1 1 0 0 1 1 0 0 1 0 0 0

D= dulling of the cornea

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the eyes
Executive summary:

In a test according to OECD 405 3 rabbits received 0.1 mL of the substance in the eye. Initial signs of irritation were fully reversible over the 72 hour (7 day) observation period. The substance is considered not irritating to the eyes.