N,N-dimethyl-3-oxobutyramide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DOT (Transport-Classification) Guideliens

Deviations:

not specified

Principles of method if other than guideline:

The study was performed before GLP- and OECD-testing guidelines were available and in force.

GLP compliance:

no

Remarks:

GLP-guidelines not yet in force at date of the study

Test material

Test material information

Constituent 1

Reference substance name:

Acetoacet Dimethylamide

IUPAC Name:

Acetoacet Dimethylamide

Constituent 2

Reference substance name:

N,N-dimethyl-3-oxobutyramide

EC Number:

218-059-8

EC Name:

N,N-dimethyl-3-oxobutyramide

Cas Number:

2044-64-6

Molecular formula:

C6H11NO2

IUPAC Name:

N,N-dimethyl-3-oxobutyramide

Test material form:

other: liquid

Details on test material:

Physical state: liquid
The material to be tested 50% aqueous solution.

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No information available.

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Test Substance: 50% aqeous solution.

Duration of treatment / exposure:

4 hours

Observation period:

4, 24 and 48 hours on intact and abraded skin.

Number of animals:

6 rabbits were used for testing.

Details on study design:

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 positions of 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 ware secured to the area by thin bands of adhesivetape. The material to be tested (50% aqueous solution) was introduced beneath the patch. The entire trunks of the animals were then
wrapped in clear plastic trunk bands.
The trunk bands help to hold the patches in Position and retard evaporation of volatile substances during the four hour exposure period. Upon
removal of the patches the resulting reactions were evaluated on the 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 initial application. The test substance was evaluated on a total of site (6 abraded and 6 intact).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4, 24 and 48 hour

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4, 24 and 48 hours

Score:

0

Irritant / corrosive response data:

No data available.

Other effects:

No data available.

Any other information on results incl. tables

The results were summarized below:

Observation	Mean values over 4, 24 & 48 hours						Mean value
	No.1	No.2	No.3	No.4	No.5	No.6
Erythema	0	0	0	0	0	0	0
Oedema	0	0	0	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:

Substance Acetoacet Dimethylamide was classified as non-irritant to skin.

Executive summary:

The study was performed 1974, following the DOT (Transport Classification) Guidelines, before GLP- and OECD-testing guidelines were available and in force and amended in year 1991 (Addendum to Lonza Report No. 0003). The intact and abraded skin of albino rabbits was employed for this study. A series of 6 rabbits was used for testing.

No erythema and no oedema was observed in all 6 animals after 4, 24 and 48 hours observation period.

Therefore, the test item is considered not irritating to rabbit skin.