Ethyldimethylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30. Mar 1973 - 04. May 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

7 days observation, lack of information about DMEA tested

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyldimethylamine

EC Number:

209-940-8

EC Name:

Ethyldimethylamine

Cas Number:

598-56-1

Molecular formula:

C4H11N

IUPAC Name:

ethyldimethylamine

Details on test material:

- Name of test material (as cited in study report): Dimethyl-aethylamin

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner, Sulzfeld
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: males: 200 g (mean); females: 178 g (mean)
- Fasting period before study: 16 h before treatment
- Housing: 5 animals per cage
- Diet: Altromin- R 1321; Altromin - GmbH, Germany, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 45 - 75 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2, 8, 10, 16 %

MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:

200, 400, 800, 1000, 1250, 1600 µl/kg bw ; equivalent to 136, 272, 544, 680, 850, 1088 mg/kg bw conversion in mg/kg is based on density: d=0.68 g/cm3 (BASF AG MSDS)

No. of animals per sex per dose:

5 males and 5 females per group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

594 mg/kg bw

95% CL:

540 - 650

Remarks on result:

other: conversion in mg/kg is based on density: d=0.68 g/cm3

Mortality:

see details in remarks on results.

Clinical signs:

other: Symptoms observed included accelerated respiration, abdominal position, squatting posture, apathy, atony, dyspnoea, tremor, nose and eye discharge. Between days 1 and 6 all symptoms reversed in surviving animals.

Gross pathology:

> 1000 mg/kg bw: congestive hyperemia, acute dilatation of the heart, dilatation of the stomach, gastritis and diffuse reddening of the stomach;
> 800 mg/kg bw: adhesion on the stomach, thickened forestomach and irregular folding at fundus.

Any other information on results incl. tables

Mortality:

Dose (mg/kg bw)	Conc. (%)	Gender	1 h	24 h	48 h	day 7
1088	16	male	0/5	5/5	5/5	5/5
1088	16	female	0/5	5/5	5/5	5/5
850	10	male	0/5	4/5	5/5	5/5
850	10	female	0/5	5/5	5/5	5/5
680	10	male	0/5	4/5	4/5	4/5
680	10	female	0/5	4/5	5/5	5/5
544	8	male	0/5	1/5	1/5	2/5
544	8	female	0/5	0/5	0/5	0/5
272	8	male	0/5	0/5	0/5	0/5
272	8	female	0/5	0/5	0/5	0/5
136	2	male	0/5	0/5	0/5	0/5
136	2	female	0/5	0/5	0/5	0/5

The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependent manner.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Conclusions:

The oral LD50 of DMEA is 594 mg/kg (540-650 mg/kg) in Sprague Dawley rats with 95% confidence interval limits.

Executive summary:

The Acute oral toxicity of Dimethylethylamine (DMEA) was evaluated in rats according to a protocol similar to the OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of DMEA at doses of 136, 272, 544, 680, 850, 1088 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 7).

10/10 animals died on day 1 after administration of 1088 mg/kg (5 males and 5 females). Animals showed congestive hyperemia, acute dilatation of the heart, dilatation of the stomach, gastritis and diffuse reddening of the stomach.

9/10 animals died on day 1 after administration of 850 mg/kg (4 males and 5 females). The last male that survived died on day 2. Animals showed adhesion on the stomach, thickened forestomach and irregular folding at fundus.

8/10 animals died on day 1 after administration of 680 mg/kg (4 males and 4 females). One additional female died on day 2.

1/10 animal died on day 1 after administration of 544 mg/kg (1 male).

No death was recorded at doses of 272 and 136 mg/kg.

Symptoms observed included accelerated respiration, abdominal position, squatting posture, apathy, atony, dyspnoea, tremor, nose and eye discharge. Between days 1 and 6 all symptoms reversed in surviving animals.

The oral LD50 of DMEA is 594 mg/kg (540-650 mg/kg) in Sprague Dawley rats with 95% confidence interval limits.