Pentane-2,4-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-01-09 to 1985-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conduction and documentation of study very acceptable. Study report available.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

publication

Title:

The acute toxicity and primary irri-tancy of 2,4-pentanedione

Author:

Ballantyne, B., Dodd, D.E., Myers R.C., Nach-reiner, D.J.

Year:

1986

Bibliographic source:

Drug and Chemical Toxicology, 9, 133-146

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as stated in report

Deviations:

no

Principles of method if other than guideline:

Male or female New Zealand White rabbits are dosed with 0.5 ml. The dose is applied to a clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml is lethal. The test material is applied to each of 6 rabbits which are restrained for teh 4 hr contact period. Excess sample is removed after contact. Skin reaction is scored by the method of Draize at one hour, one day, 2 days, 3 days 7 days and depending on the local skin reaction possibly 14 days after dosing.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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

Details on test material:

- Name of test material (as cited in study report): 2,4-Pentanedione
- Substance type: industrial chemical
- Physical state: liquid
- Analytical purity: > 99%
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 496500
- Expiration date of the lot/batch: not given
- Stability under test conditions: stable
- Storage condition of test material: not given

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Concentration: 0.5 ml undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

14 days

Number of animals:

6 (3 males/3 females)

Details on study design:

0.5 ml undiluted TS applied on the dorsal skin of 6 New Zealand White rabbits (3 males and 3 females, respectively) for 4h with occlusive dressing; test sites were inspected 1 hour and 1, 2, 3, 7 and 14 days after removal of the dressing.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 5 hours to 3 days

Score:

>= 0.5 - <= 1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 5 hours to 3 days

Score:

>= 0.2 - <= 1.2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

One hour after removal of the occlusive dressing slight erythema detectable in 5/6 animals; after 24 hours erythema detectable in 6/6 animals; moderate edema formation observable in 1/6 rabbits and slight edema formation in 5/6 rabbits one hour after removal of the occlusive dressing; after 24 hours slight edema still present in 5/6 rabbits. After 48 and 72 hours five and three animals revealed just detectable erythema, respectively; Mild edema were observable at 48 and 72 hours in two and one animals, respectively. With the exception of mild desquamation no effects on day 7. Other irritations of effects were not detectable at any observation time.

Other effects:

none reported

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating

Executive summary:

A 4 hour application of 0.5 ml of Acetylacetone (2,4 -Pentanedione) was applied on 3 male and 3 female New Zealand White rabbits dosed with 0.5 ml. The dose is applied to a clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml is lethal. The test material was applied to each of 6 rabbits which are restrained for the 4 hr contact period. Excess sample is removed after contact. Skin reaction were scored by the method of Draize at one hour, one day, 2 days, 3 days 7 days and depending on the local skin reaction possibly 14 days after dosing.

One hour after removal of the occlusive dressing slight erythema detectable in 5/6 animals; after 24 hours erythema detectable in 6/6 animals; moderate edema formation observable in 1/6 rabbits and slight edema formation in 5/6 rabbits one hour after removal of the occlusive dressing; after 24 hours slight edema still present in 5/6 rabbits. After 48 and 72 hours five and three animals revealed just detectable erythema, respectively; Mild edema were observable at 48 and 72 hours in two and one animals, respectively. With the exception of mild desquamation no effects on day 7. Other irritations or effects were not detectable at any observation time. Acetylacetone has not to be classified according to the slight reactions observed under the conditions used.