Methyl acetoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed in accordance with the corresponding OECD-/EU-testing guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl acetoacetate

EC Number:

203-299-8

EC Name:

Methyl acetoacetate

Cas Number:

105-45-3

Molecular formula:

C5H8O3

IUPAC Name:

methyl 3-oxobutanoate

Test material form:

other: non-viscous clear liquid

Details on test material:

- Molecular formula: C5H8O3
- Physical state: Colourless liquid
- Storage condition of test material: Room temperature, protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- number of animals: 3
- Weight at study initiation: 2200-2600 mg/kg
- Housing: single housing

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml test item was applied on a 2.5 x 2.5 cm patch

Duration of treatment / exposure:

4 hours

Observation period:

Observation 30 minutes, 24 hours, 48 hours and 72 hours after removal of patch

Number of animals:

3 animals

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Only very slight erythema in all animals and very slight oedema in one animal were observed. 2 out of three animals showed a slight redness of the application site 30 minutes after removal of the patch. All findings were completely reversible within 48 hours.

Other effects:

None

Any other information on results incl. tables

The results are summarized below:

 

Observation	Mean values over 24, 48 & 72 hours			Mean value
	No.1	No.2	No.3
Erythema	0.3	0.3	0	0.2
Oedema	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was classified as non-irritant to skin.

Executive summary:

The study was performed in 1983 under GLP according to OECD 404. Three albino rabbits were treated semi-occlusive with 0.5 ml test item was applied on a 2.5 x 2.5 cm patch. Observation times were 24, 48 and 72 hours after removal of the patch. Only very slight erythema in all animals and very slight oedema in one animal were observed. 2 out of three animals showed a slight redness of the application site 30 minutes after removal of the patch. All findings were completely reversible within 48 hours. Therefore, MAA is not irritating to rabbit skin.