3-methoxy-N,N-dimethylpropionamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 October 2006 - 16 November 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

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:

rat

Strain:

other: Crl: CD® (SD) IGS BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Eight to twelve weeks
- Weight at study initiation: 198 - 223g
- Fasting period before study: Overnight before dosing until three to four hours after dosing.
- Housing: Group housing of 3 animals per cage in suspended solid-floor polypropylene cages.
- Diet: Free access to Certified Rat and Mouse diet.
- Water: Free access to mains water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS set to maintain:
- Temperature (°C): 19 – 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

GAVAGE METHOD: metal cannula attached to a graduated syringe.

Frequency: single dosage, on Day 1.

MAXIMUM DOSE VOLUME APPLIED:
300 mg/kg (10 mL/kg) body weight.
2000 mg/kg (Dose volume calculated as dose level (g/kg) / specific gravity)

DOSAGE PREPARATION: For the purpose of the 300 mg/kg dose level the test material was freshly prepared, as required, as a solution at the appropriate concentration in distilled water. For the purpose of the 2000 mg/kg dose level the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 300 mg/kg was chosen as the starting dose.

Doses:

300 and 2000 mg/kg body weight

No. of animals per sex per dose:

2000 mg/kg: 6 (2 groups of three females in a stepwise manner)
300 mg/kg: 3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/overt signs of toxicity: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Body weights: Prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination.
- Other examinations performed: none.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: There were no signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg bw. In the 2000 mg/kg bw dose group, hunched posture and ataxia were noted in all animals during the day of dosing with hunched posture noted in all animals one

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

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

Conclusions:

In an acute oral toxicity study with female rats, performed according to OECD 423 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.

Executive summary:

3-methoxy-N,N-dimethylpropanamide was tested at 300 and 2000 mg/kg bw in an acute oral toxicity study with female rats, performed according to OECD 423 test guideline and GLP principles.

No mortality occurred. There were no signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg bw. In the 2000 mg/kg bw dose group, hunched posture and ataxia were noted in all animals during the day of dosing with hunched posture noted in all animals one day after dosing and in three animals two days after dosing. Animals in this dose group appeared normal two or three days after dosing.

All animals showed expected gains in bodyweight over the study period and no abnormalities were noted at necropsy.

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