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Toxicological information

Skin irritation / corrosion

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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.