Pentane-2,4-dione

Eye irritation

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: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1986

Reference 3

Reference Type:

secondary source

Title:

Unnamed

Year:

2001

Materials and methods

Principles of method if other than guideline:

Draize test.
Female New Zealand White rabbits were tested for eye irritation. 0.1 mL of undiluted 2,4-pentanedione was instilled into the lower conjunctival sac of one eye per animal or was placed directly on the eye. The eyelids were held together for a second. The effects were scored according to Draize at one hour, approximately 6 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2 %) staining was used to determine corneal injury before dosing and at readings after one day.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Details on test material:

Purity: >99%
Physical state: yellow, transparent non-viscous liquid
Lot No.: 496-500

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing performed.

SCORING SYSTEM: Draize scheme

TOOL USED TO ASSESS SCORE:
Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No effects on the cornea were observed throughout the study period.

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: No effects were observed throughout the study period.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: Slight effects were only observed after 1 and 4 hours.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Slight effects were only observed after 1 and 4 hours.

Irritant / corrosive response data:

After 1 h:
Slight redness of the conjunctivae was observable in 5/6 animals (average score 0.8). Slight chemosis in 2/6 and moderate chemosis in 1/6 animals (average score 0.7); slight discharge in 2/6 and moderate discharge in 3/6 animals (average score 1.3); slight inflammation of the iris in 2/6 animals (average score 0.3).
After 4 h:
Slight inflammation of the iris in 1/6 animals (score 0.2); slight redness of the conjunctivae in 4/6 animals (average score 0.7); slight chemosis in 2/6, moderate chemosis in 1/6 animals (average score 0.7); slight conjunctival discharge in 3/6 and moderate conjunctival discharge in 2/6 animals (average score 1.2).
24 hours post-instillation all eyes healed. Opacities of the cornea were not observable at any time.

Any other information on results incl. tables

Table 1: Individual eye scores of the six rabbits at 1, 4, 24, 48, and 72 h after beginning of the treatment.

Animal			conjunctivae
	cornea	iris	redness	Chemosis
1
1 h	0	0	1	1
4 h	0	0	1	1
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0	0
2
1 h	0	0	0	0
4 h	0	0	0	0
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0	0
3
1 h	0	0	1	0
4 h	0	0	1	0
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0	0
4
1 h	0	0	1	0
4 h	0	0	0	0
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0	0
5
1 h	0	1	1	2
4 h	0	1	1	2
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0	0
6
1 h	0	1	1	1
4 h	0	0	1	1
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not eye irritating under the evaluated conditions of this study.

Executive summary:

6 New Zealand White rabbits received treatment of 0.1 mL of the undiluted test substance. 

No washing was performed. Readings were performed 1, 4, 24, 48 and 72h after administration. The observation period was 7 days.

The test substance did not show eye irritating properties.