Acetoacetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Study conducted prior to GLP and OECD guideline implementation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

DOT (Transport-Classification) Guideline

Deviations:

not specified

GLP compliance:

no

Remarks:

Study conducted prior to GLP and OECD guideline implementation.

Test material

Test material information

Constituent 1

Reference substance name:

Acetoacetamide

EC Number:

227-774-4

EC Name:

Acetoacetamide

Cas Number:

5977-14-0

Molecular formula:

C4H7NO2

IUPAC Name:

acetoacetamide

Test material form:

solid

Specific details on test material used for the study:

not available

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

albino rabbits

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

48 hours after initial application

Number of animals:

6

Details on study design:

The intact and abraded skin of 6 albino rabbits was employed for this study. The hair was clipped from the backs with the aid of angora clippers. Four areas of the back, placed approximately ten centimeters apart, were designated for the patches. Areas 2 and 3 were abraded by making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape. The material to be tested (0.5 grams) was introduced beneath the patch. The entire trunks of the animlas were then wrapped in claear plastic trunk bands. The trunk bands help to hold the patches in position and retard evaporation of volatile substances during the four hours exposure period. Upon removal of the patches the resulting reactions were evaluated on basis of weighted scores.
Following this initial reading, all test sites were washed with appropriate solvent to prevent further exposure. Readings were again made at 24 and 48 hours after the iniitial application. Each test substance is evaluated on a total of site (6 abraded and 6 intact)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no signs of irritation (erythema) at any time

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no signs of irritation (erythema) at any time

Remarks on result:

no indication of irritation

Other effects:

No other effects reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the findings, Acetoacet Amide is not irritating to the rabbit skin.

Executive summary:

6 albino rabbits were tested for skin irritation with Acetoacet Amide according to a company guideline similar to OECD 404. Following this guideline 0.5 g of the test item were tested at the intact and abraded skin under occlusive coverage.

The exposure period was 4h. After removal of the patch the remnant test item was removed with appropriate solvent. The observation period was 48 hours after initial application.

None of the animals showed any signs of skin irritation or corrosion at any time.