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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 2 animals tested; 50µl instead of 100µl instilled; no observation point after 72 hours, Maximum observation time was 8 days
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyric anhydride
EC Number:
202-603-6
EC Name:
Isobutyric anhydride
Cas Number:
97-72-3
Molecular formula:
C8H14O3
IUPAC Name:
isobutyric anhydride
Details on test material:
- Physical state: liquid
no further data provided

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean: 3.08 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: treatment of the control eye with physiol. saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): unchanged

Duration of treatment / exposure:
not washed out
Observation period (in vivo):
1, 24, 48 hours and after 8 days
Number of animals or in vitro replicates:
2 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize (re-evaluation according to the scoring system of Draize as recommended by the actual guideline requirements

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
1.8
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Table 1: Individual results:

Readings

Animal

Cornea

Iris

conjunctiva

Symptoms

opacity

redness

swelling

discharge

1 h

1

1

0

2

2

2

 

2

1

0

2

2

2

 

24 h

1

1

0

1

2

1

 

2

2

0

2

2

1

 

48 h

1

2

1

2

2

3

 

2

2

1

2

2

3

Na

8d

1

1

0

1

0

1

 

2

1

0

1

0

0

Na

mean 24 - 48 h

1

1.5

0.5

1.5

2.0

2.0

 

2

2.0

0.5

2.0

2.0

2.0

 

mean

 

1.8

0.5

1.8

2.0

2.0

 

Na: Scar

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information

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