N,N-Diethylacrylamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1993-05-18 to 1993-05-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulation, Title 16, Section 1500.41

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-diethylprop-2-enamide

EC Number:

679-769-5

Cas Number:

2675-94-7

Molecular formula:

C7-H13-N-O

IUPAC Name:

N,N-diethylprop-2-enamide

Specific details on test material used for the study:

Batch No.: not specified
Purity: not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfied (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: approximately 13 to 14 weeks
- Weight at study initiation: 2.9 to 3.3 kg
- Housing: be housed individually in plastic cages with perforated floors
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30 to 70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hours period

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 100 mm x 100 mm
- Type of wrap if used: "Elastoplast " elastic adhesive dressing backed with "Sleek" waterproof strapping.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treament sites were washed with warm water (30 to 40 °C)

OBSERVATION TIME POINTS: on Day 2 (i.e. approximately 30 min after removal of dressings) and on Day 4 (equivalent to 24 and 72 hours after exposure).

SCORING SYSTEM: Draize
- Method of calculation: the numberical scores for erythema and oedema at both 24 and 72 hour readings for both intact and abraded skin sites were added together and divided by 24 to give the primary irritation index (PII)

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:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Remarks:

only scored at 24 h and 72 h, not determined at 48h

Irritant / corrosive response data:

Very slight to well-defined erythema with or without very slight to slight oedema was seen at the intact and abraded sites of all six animals at the 24 hours reading. By the 72 hours reading very slight to moderate erythema and oedema was seen in all six animals. Harding of the skin was seen at the abraded site of two animals at the 72 hours reading. Very slight to well-defined erythema with or without very slight to slight oedema was seen at the intact and abraded sites of all six animals at the 24 hours reading. By the 72 hours reading very slight to moderate erythema and oedema was seen in all six animals. Harding of the skin was seen at the abraded site of two animals at the 72 hours reading.

Any other information on results incl. tables

Dermal reaction observed after application of test item

Rabbit number and sex	E=Erythema    O=Oedema	24 hours		72 hours
		intact	abraded	intact	abraded
1939 female	E	1	1	1	1
	O	0	0	1	1
1946 female	E	2	2	2	2
	O	2	2	2	2
1941 male	E	2	2	2	b3
	O	2	2	2	3
1942 male	E	2	2	2	b3
	O	1	2	2	3
1943 male	E	2	2	2	3
	O	1	2	2	2
1944 female	E	1	2	1	3
	O	0	2	1	2

Applicant's summary and conclusion

Interpretation of results:

other: classified as a moderate irritant

Conclusions:

A single occlusive application of test item to intact and abraded rabbit skin for 24 hours elicited well-defined to moderate dermal reactions and is classified as moderate irritant.

Executive summary:

The study was performed to assess the skin irritation potential of the test item to the rabbit. The method followed in Code of Federal Regulations, Title 16, Section 1500.41.

 

Six rabbits were each administered a dermal dose of 0.5 ml of test substance to one intact and one abraded skin site and observed for three days.

 

A single occlusive application on test item to intact and abraded rabbit skin for 24 hours elicited well-defined to moderate dermal reactions.