Pentane-2,4-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 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:

secondary source

Title:

Unnamed

Year:

2001

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Principles of method if other than guideline:

Draize test.
0.5 mL undiluted 2,4-pentanedione were applied to the clipped, intact dorsal skin of 6 New Zealand White rabbits (3 males and 3 females) under a gauze patch and were loosely covered with impervious sheeting. Skin reaction was scored by the method of Draize at 1 hour and 1, 2, 3, 7 and 14 days after removal of the dressing.

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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 days

Number of animals:

6

Details on study design:

TEST SITE
- Dorsal skin
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE: no data

SCORING SYSTEM: Draize scheme
-Observations performed after 1hour and 1, 2, 3, 7 and 14 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: On day 7 only mild desquamation was observed.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: On day 7 only mild desquamation was observed.

Irritant / corrosive response data:

One hour after removal of the occlusive dressing slight erythema were detectable in 5/6 animals (average score 0.8). After 24 hours erythema were detectable in 6/6 animals (average score 1.0).
Moderate edema formation was observed in 1/6 rabbits and slight edema formation in 5/6 rabbits one hour after removal of the occlusive dressing (average score 1.2). After 24 hours slight edema were still present in 5/6 rabbits (average score 0.8). After 48 and 72 hours five and three animals revealed just detectable erythema, respectively (average scores 0.8 and 0.5). Mild edema were observable at 48 and 72 hours in two and one animals, respectively (average scores 0.3 and 0.2). With the exception of mild desquamation no effects were observed on day 7. Other effects were not detectable at any observation time.

Any other information on results incl. tables

Table 1: Individual erythema and edema score after 5 h up to 14 days (d: desquamation):

Exposure time 4 h
	Animal 1	Animal 2	Animal 3	Animal 4	Animal 5	Animal 6
	5 h
erythema	1	1	1	1	1	0
edema	1	2	1	1	1	1
	24 h
erythema	1	1	1	1	1	1
edema	1	1	1	1	0	1
	48 h
erythema	1	1	1	1	0	1
edema	0	1	0	1	0	0
	72 h
erythema	0	1	1	1	0	0
edema	0	1	0	0	0	0
	7 d
erythema	0	0	0	0	0	0
edema	0	0, d	0, d	0, d	0, d	0, d
	14 d
erythema	0	0	0	0	0	0
edema	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the evaluated conditions, the test material does not show a skin irritation potential.

Executive summary:

6 New Zealand White rabbits were dermally exposed to 0.5 mL undiluted test substance under occlusive conditions for 4 hours. Readings were performed after 1 hour and 1, 2, 3, 7, and 14 days. One hour after removal of the occlusive dressing slight erythema were detectable in 5/6 animals (average score 0.8). After 24 hours erythema were detectable in 6/6 animals (average score 1.0).
Moderate edema formation was observed in 1/6 rabbits and slight edema formation in 5/6 rabbits one hour after removal of the occlusive dressing (average score 1.2). After 24 hours slight edema were still present in 5/6 rabbits (average score 0.8). After 48 and 72 hours five and three animals revealed just detectable erythema, respectively (average scores 0.8 and 0.5). Mild edema were observable at 48 and 72 hours in two and one animals, respectively (average scores 0.3 and 0.2). With the exception of mild desquamation no effects were observed on day 7. Other effects were not detectable at any observation time.