Isopropyl acetoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-12 to 1988-01-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1984-04-25

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl acetoacetate

EC Number:

208-798-4

EC Name:

Isopropyl acetoacetate

Cas Number:

542-08-5

Molecular formula:

C7H12O3

IUPAC Name:

propan-2-yl 3-oxobutanoate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: individual cages
- Diet: ad libitum, rabbit diet Altromin 2123 and hay
- Water: ad libitum, deionised and chlorinated water
- Acclimation period: not detailed

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): not detailed, but air condition in animal rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm area covered with a band aid, in a ca. 25 cm² clipped area on the dorsal trunk of each rabbit
- Type of wrap: band aid covered with a semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm tap water
- Time after start of exposure: after exposure time of 4 h

OBSERVATION TIME POINTS
30 minutes and 1, 24, 48 and 72 h after exposure

SCORING SYSTEM:
Erythema and eschar formation:
0: no erythema
1: slight, barely perceivable, erythema
2: well-defined erythema
3: mild to severe erythema
4: severe erythema (intense redness) to formation of eschar (penetrative injury)

Edema formation:
0: no edema
1: slight, barely perceivable, edema
2: slight edema (with swelling at well-defined boundary)
3. mild edema (swelling ca. 1 mm)
4. severe edema (swelling of more than 1 mm and larger than exposure area)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effect observed.

Other effects:

No further effects were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item showed no skin irritation potential in a in vivo study in rabbits.

Executive summary:

The skin irriation potential of the test item was evaluated using an in vivo study according to OECD 404 in three rabbits. The undiluted test item was applied to a clipped area on the dorsal trunk of the animals under semiocclusive cover. The exposure time was 4 hours. Afterwards residual test item was removed by washing with lukewarm water. The test site was evaluated after 30 minutes and 1, 24, 48 and 72 hours. The animals showed a mean erythema score for 24/48/72 h of 0.9 with no individual animal scoring higher than 1.0. The mean edema score for 24/48/72 h was 0.1 with the mean score for one animal at 0.3 and 0.0 for the remaining two animals. All effects observed were reversible within 72 h. Based on the results of the in vivo study in rabbits the test item was determined not to cause skin irritation or corrosion.