N,N-diethyl-3-oxobutyramide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth et.al

Year:

1962

Bibliographic source:

American Industrial Hygiene Association Journal, 1962

Reference 2

Reference Type:

other: authoritative database

Title:

GSBL for the CAS: 2235-46-3

Author:

German Federal Ministry for the Environment, Nature Conservation and Nuclear Safety and the Environmental Ministries of all 16 Federal States of Germany (Länder)

Year:

2018

Bibliographic source:

GSBL – Joint Substance Data Pool of the German Federal Government and the German Federal States, 2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Primary dermal irritation study was performed in rabbits to assess the irritation potential of N,N-diethyl-3-oxobutanamide

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N-diethyl-3-oxobutyramide

EC Number:

218-792-3

EC Name:

N,N-diethyl-3-oxobutyramide

Cas Number:

2235-46-3

Molecular formula:

C8H15NO2

IUPAC Name:

N,N-diethyl-3-oxobutanamide

Test material form:

liquid

Details on test material:

- Name of test material : N,N-diethyl-3-oxobutanamide- Molecular formula: C8H15NO2- Molecular weight: 157.212 g/mol- Smiles notation: N(C(CC(C)=O)=O)(CC)CC- InChl : 1S/C8H15NO2/c1-4-9(5-2)8(11)6-7(3)10/h4-6H2,1-3H3- Substance type: Organic- Physical state: Liquid

Specific details on test material used for the study:

- Name of test material : N,N-diethyl-3-oxobutanamide- Molecular formula: C8H15NO2- Molecular weight: 157.212 g/mol- Smiles notation: N(C(CC(C)=O)=O)(CC)CC- InChl : 1S/C8H15NO2/c1-4-9(5-2)8(11)6-7(3)10/h4-6H2,1-3H3- Substance type: Organic- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

no data available

Test system

Type of coverage:

open

Preparation of test site:

other: closely clipped abdominal skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.01 ml of undiluted sample

Duration of treatment / exposure:

24 hours

Observation period:

24 hours

Number of animals:

5

Details on study design:

TEST SITEArea of exposure: closely clipped, intact abdominal skin% coverage: No dataType of wrap if used: no wrap used REMOVAL OF TEST SUBSTANCEWashing (if done): no dataTime after start of exposure: no dataSCORING SYSTEM:Primary skin irritation on rabbits was recorded in a 10-grade ordinal series. Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

10

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Grade 1- no isgns of irritation observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Acute dermal irritation study was carried out to assess the irritation potential of N,N-Diethyl-3-oxobutyramide.Primary Dermal Irritation score for N,N-Diethyl-3-oxobutyramide was Grade 1.Based on the grade, N,N-Diethyl-3-oxobutyramide was considered to be not irritating to skin.

Executive summary:

Acute dermal irritation study was carried out to assess the irritation potential of N,N-Diethyl-3-oxobutyramide.

 

Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that develops on the clipped abdominal skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 ml of undiluted sample or of solutions in water, propylene glycol, or acetone.

Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution.Primary Dermal Irritation score forN,N-Diethyl-3-oxobutyramidewas Grade 1.

Based on the grade, N,N-Diethyl-3-oxobutyramide was considered to be not irritating to skin.