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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed data

Data source

Reference
Reference Type:
publication
Title:
The acute toxicity and pimary irrintancy of 2,4-Pentadione
Author:
Ballantyne et al.
Year:
1986
Bibliographic source:
drug and chemical toxicology, 9(2), 133-146 (1986)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-2,4-dione
EC Number:
204-634-0
EC Name:
Pentane-2,4-dione
Cas Number:
123-54-6
Molecular formula:
C5H8O2
IUPAC Name:
pentane-2,4-dione

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- weight: 2.0 - 3.0 kg
- environmental temperature: 68-75°C mentioned in publication, assumed to be 68-75°F, corresponding to 20-23.9°C
- relative humidity: 30-65%
- 12hr light-dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Eyelids were held together for 1 sec after instillation to prevent loss of test material.
Observation period (in vivo):
7 days. Eyes were inspected for signs of local inflammation at 1, 4, and 24 hours, and 2, 3, and 7 days postinstallation.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE: Washing (if done): unwashed exposure
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
please refer to 'Any other information on results'

Any other information on results incl. tables

Effects (scores see table below):

Conjunctivae: just detectable excess conjunctival redness in 5 of 6 animals at 1 h postinstallation

Chemosis: slight chemosis in 2 of 6 animals, moderate chemosis in 1 of 6 animals

Iritis: mild iritis in 2 of 6 animals, persisting up to 4 h

Table 1: Scores for the various effects seen in rabbit eyes following the installation of 0.1 mL acetylacetonate into the inferior conjunctival sac of one eye of each of six rabbits (scored according to the system of Draize)

Time

Effect as average (and range)

 

Conjunctiva

Iris

 

Redness

Chemosis

Discharge

 

1 h

0.8 (0-1)

0.7 (0-2)

1.3 (0-2)

0.3 (0-1)

4 h

0.7 (0-1)

0.7 (0-2)

1.2 (0-2)

0.2 (0-1)

24 h

0.0

0.0

0.0

0.0

Reversibility: All eyes were healed by 24 h postinstallation. No evidence of corneal injury on macroscopic inspection or following the installation of 2% fluorescein.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Mean scores at 1 and 4 hours for conjunctival redness and iritis were 0-1 in all animals. Mean scores at 1 and 4 hours for each animal for chemosis and discharge was 0-2 for all animals. Effects were fully reversible, as no effects were seen after 24 h.
Therefore, the acetylacetonate test substance is minimal irritating to rabbit eyes.
Executive summary:

In this study, the eye irritation potential of the acetylacetonate test substance was evaluated in accordance with OECD Guideline 405. A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 mL of the test article instilled into the lower conjunctival sac of one eye. The eyelid was held closed for one second and released. Observations for eye irritation were made at 1, 4, and 24 hours following dosing and on days 2, 3, and 7. Mean scores at 1 and 4 hours for conjunctival redness and iritis were 0-1 in all animals. Mean scores at 1 and 4 hours for each animal for chemosis and discharge was 0-2 for all animals. Effects were fully reversible, as no effects were seen after 24 h.

Therefore, the acetylacetonate test substance is minimal irritating to rabbit eyes, but it does not meet the criteria for classification as laid down in Regulation (EC) No 1272/2008.