3-methoxy-N,N-dimethylpropionamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 November 2006 - 02 December 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxy-N,N-dimethylpropionamide

EC Number:

258-420-7

EC Name:

3-methoxy-N,N-dimethylpropionamide

Cas Number:

53185-52-7

Molecular formula:

C6H13NO2

IUPAC Name:

3-methoxy-N,N-dimethylpropanamide

Test material form:

liquid

Details on test material:

- Appearance: Extremely pale yellow liquid
- Storage condition of test material: Approximately 4°C in the dark under nitrogen

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited supplier (not specified).
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Animals were housed individually in suspended cages.
- Diet: Free access to Certified Rabbit diet (not specified)
- Water: Free access to mains drinking water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 17 – 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

First animal a single application for 3 minutes, 1 hour and 4 hours.
Two animals a single application for 4 hours.

Observation period:

14 days.

Number of animals:

3 males.

Details on study design:

STUDY DESIGN
One rabbit was initially treated. After considerationof the skin reactions produced in the first animal, two additional animals were treated.

TEST SITE
On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

Three suitable sites were selected on the back of the rabbit. At each site a quantity of 0.5 mL of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the 1 and 4 hour exposure periods.

REMOVAL OF TEST SUBSTANCE
3 minutes, 1 hour and 4 hours after the application, the patch was removed and the skin cleaned of residual test substance by gentle swabbing with cotton wool soaked in distilled water.

After consideration of the skin reactions produced in the first animal, two additional animals were treated.
One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.

OBSERVATIONS
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

In a skin irritation study with three male rabbits, performed according to OECD 404 test guideline and GLP principles, no irritation was observed.

Executive summary:

3-methoxy-N,N-dimethylpropanamide was tested in a skin irritation study with three male rabbits, performed according to OECD 404 test guideline and GLP principles.

No evidence of skin irritation was noted during the study.

Based on the results, 3-methoxy-N,Ndimethylpropanamide does not have to be classified for skin irritation according to Regulation (EC) No. 1272/2008.