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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
no data
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:
harmful
Remarks:
Migrated information category 4 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008
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.