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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (405): pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Draize method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.2 ml
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
4
Details on study design:
The conjunctival redness chemosis and discharge, corneal opacity and damge to the iris following the instillation of 0.2 mL undiluted chemical into the conjunctival sac of two rabbit eyes was scored using standard scales.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1-2 h
Score:
6.3
Remarks on result:
other: out of 16 (Cornea, Iris and Conjunctivae)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
9.6
Remarks on result:
other: out of 16 (Cornea, Iris and Conjunctivae)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
10
Remarks on result:
other: out of 16 (Cornea, Iris and Conjunctivae)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
9.7
Remarks on result:
other: out of 16 (Cornea, Iris and Conjunctivae)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
3.8
Remarks on result:
other: out of 16 (Cornea, Iris and Conjunctivae)
Other effects:
Severe pain response

Any other information on results incl. tables

 

Mean response

 

1-2 hours

1 day

2 days

3 days

7 days

Conjunctiva

 

 

 

 

 

Redness

2.0

2.0

2.0

2.0

1.0

Chemosis

2.0

3.0

3.0

2.5

0

Discharge

0.3

1.0

1.0

1.2

0

Cornea

 

 

 

 

 

Opacity

2.0

2.0

2.0

2.0

1.5

Area

4.0

4.0

4.0

4.0

4.0

Iris

0

1.6

2.0

2.0

1.3

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
The test material was severely irritating to rabbit eyes.
Executive summary:

On the basis of this study pivalic acid is considered to be an irritant to the eye.