3-methoxy-N,N-dimethylpropionamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 July 2011 - 10 August 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

30 may 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

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: Clear colourless liquid
- Storage condition of test material: Room temperature (15-25°C)

Test animals

Species:

rat

Strain:

other: Wistar strain, RjHAN:(WI)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: JANVIER S.A.S.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals
- Weight at study initiation: 224 - 245g
- Housing: Individual housed in type II polypropylene/polycarbonate cages
- Diet: Free access to autoclavable complete feed for rats and mice - breeding and maintenance (SM R/M-Z+H from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water from the municipal supply.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS set to maintain
- Temperature (°C): 22.0 – 24.8
- Humidity (%): 47 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before exposure (Day -1) the back of each animal was shaved (approx. 10% of the total body surface).

The formulation was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24 hour exposure period. For that purpose, the appropriate amount of the test item was moistened with water and distributed as uniformly as possible. Sterile gauze pads were placed on the skin of the rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.

At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: no data
Body weights: On Day 0 (before test item administration) and on Days 7 and 14.
Clinical signs: On the day of dosing at 1 and 5 hours after application of the test item and once each day for 14 days thereafter.
- Necropsy of survivors performed: Yes
- Other examinations performed: none.

Statistics:

None.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed after treatment with the test item or during the 14-day observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No local effects were observed after treatment with the test item or during the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

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

Conclusions:

In an acute dermal toxicity study with male and female rats, performed according to OECD 402 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.

Executive summary:

3-methoxy-N,N-dimethylpropanamide was tested at 2000 mg/kg bw in an acute dermal toxicity study with male and female rats, performed according to OECD 402 test guideline and GLP principles.

No mortality occurred. No clinical signs and no local effects were observed after treatment with the test item or during the 14-day observation period. The body weight and body weight gain did not show any test item-related effect. No abnormalities were noted at necropsy.

Based on the results, an LD50 >2000 mg/kg bw was determined and 3-methoxy-N,Ndimethylpropanamide does not have to be classified for acute dermal toxicity according to Regulation (EC) No. 1272/2008.

Categories Display