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Description of key information

In rats, the oral DL50 is 594 mg/kg, the 1-hour LC50 is between 2.3 and 15.4 mg/l air and the dermal LD0 is higher than 2000 mg/kg.

Oral route

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) (BASF AG, 1973). 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.

The Acute oral toxicity of Dimethylethylamine (DMEA) was evaluated in male and female mice (Truhaut, 1976). Groups of 10 Swiss mice were administered orally DMEA solution at 170, 340, 510, 680, 850, 1190 and 1700mg/kg and animals were observed during 7days. After administration, mice died within 24hours. No mortality was observed after Day2. Under these experimental conditions, the oral LD50 of DMEA is 650+/-50 mg/kg in male mice and 600+/-50 mg/kg in female mice.

Inhalation

The acute inhalation toxicity of Dimethylethylamine (DMEA) was evaluated in a 1-hour, single-exposure study in rats (BASF AG, 1980). DMEA was initially administered to a single group of 10 male and 10 female Sprague Dawley rats via whole-body vapor exposure at concentrations between 2.3 and 15.4 mg/l. Mortality and clinical signs were evaluated daily over a 14-day observation period. Animals were weighted on days 0, 7 and 14.Mortality was 0/20 at 2.3mg/l and 18/20 (10 males and 8 females) at 15.4 mg/l. All death occurred during exposure.During the 1-hour exposure, animals exposed to 2.3 mg/l air showed a slight increased salivation. Animals exposed to 15.4 mg/l air showed a decreased respiratory rate, gasping, slight apathy, eyelid closure, increased salivation, nasal secretion; furthermore, decreased response to touch, decreased reflex reactions (pain and auricle reflex), overall a poor general state was observed. In female rats trembling of the whole body and hunched posture were observed. During observation period, 1 male exposed to 2.3 mg/l air showed alopecia after 13 days of observation. After exposure to 15.4 mg/L air, surviving animals displayed gasping, slight apathy, lid closure, slight increased salivation, reduced pain reflex, tremor and twitching, piloerection. After 6 days they were without symptoms. 11 out of 18 dying animals showed diffuse alveolar emphysema; 1 animal presented atelectasis. At necropsy, in the low dose group 9/20 animals showed a grey-red discoloration of the lung and sporadic paetechia were seen. Based on the results of this study, the LC50 for 1-hour exposure to DMEA was between 2.3 and 15.4 mg/l air.

Dermal route

The Acute dermal toxicity of Dimethylethylamine (DMEA) was evaluated in male and female Sprague Dawley rats according to OECD N°402 guideline (Clouzeau, 1993). Ten rats were applied dermally 2000 mg/kg for 24 hours and then observed during 14days. No control group was used. Neither death nor clinical signs were recorded during the study showing that under these experimental conditions, the dermal LD0 of DMEA is higher than 2000 mg/kg in rats.

The acute dermal toxicity of Dimethylethylamine (DMEA) was also evaluated in rabbits (BASF AG, 1979). DMEA was applied unchanged in a dose of 200 mg/kg for 24 hours to the clipped skin of the back and flank (area about 50 cm2) of groups of 5 male and 5 female Vienna rabbits at doses of 200 mg/kg in a semi-occlusive dressing for 24 hours.  Following treatment, rabbits were observed daily and a gross necropsy examination was performed at the time of scheduled euthanasia (Day 8). None of the tested 5 male or 5 female rabbits died within the observation period of 8 days. No abnormality was observed at necropsy. Under these experimental conditions, the dermal LD0 of DMEA is higher than 200 mg/kg in Vienna rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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.
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
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

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
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.

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.

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.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
7days post-exposure observation
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 25+/-2g
- Fasting period before study: no data
- Housing:no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period:no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: To:no data
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1mL/40g
Doses:
170, 340, 510, 680, 850, 1190, 1700mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:no data
- Necropsy of survivors performed: yes
- Other examinations performed: no data
Statistics:
DL50 calculated according to Miller-Tainter's method
Sex:
male
Dose descriptor:
LD50
Effect level:
680 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Mortality:
No mortality after day 2. All death occured within 24hours.
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Doses

Mortality

Male mice

Female mice

170

0/10

0/10

340

0/10

1/10

510

2/10

2/10

680

6/10

6/10

850

8/10

8/10

1190

9/10

10/10

1700

10/10

10/10

 

Conclusions:
LD50 in male mice is 680+/-50mg/kg and LD50 in female mice is 600+/-40mg/kg.
Executive summary:

The Acute oral toxicity of Dimethylethylamine (DMEA) was evaluated in male and female mice. Groups of 10 Swiss mice were administered orally DMEA solution at 170, 340, 510, 680, 850, 1190 and 1700mg/kg and animals were observed during 7days.

After administration, mice died within 24hours. No mortality was observed after Day2.

Under these experimental conditions, the oral LD50 of DMEA is 650+/-50mg/kg in male mice and 600+/-50mg/kg in female mice.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
594 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Weight at study initiation: 200 - 300 g
- Housing: 2 animals per cage
- Diet: HERILAN, MRH-Haltungsdiaet, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 7 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 28.5 L


TEST ATMOSPHERE
- Brief description of analytical method used: H2SO4-method
- Samples taken from breathing zone: yes


Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
1 h
Concentrations:
Actual: 2.3 and 15.4 mg/L
Nominal: 3.5 and 21.2 mg/L
No. of animals per sex per dose:
10 per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.3 - < 15.4 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
See details in remarks on results
Clinical signs:
other: During exposure: 2.3 mg/L air: slight increased salivation; 15.4 mg/L air: decreased respiratory rate, gasping, slight apathy, eyelid closure, increased salivation, nasal secretion; furthermore, decreased response to touch, decreased reflex reactions (pai
Body weight:
The surviving animals gained weight - see details in remarks on results.
Gross pathology:
Dying animals: 11 out of 18 animals showed diffuse aleolar emphysema; 1 animal with atelectasis.
Sacrificed animals: in the low dose group 9/20 animals showed a grey-red discoloration of the lung and sporadic patechia were seen.

Mortality:

 Dose (mg/L air)  Gender  15 min  30 min  24 h  14 days
 2.3  male  0/10  0/10  0/10  0/10
 2.3  female  0/10  0/10  0/10  0/10
 15.4  male  7/10  10/10  10/10  10/10
 15.4  female  3/10  8/10 8/10  8/10

All death occured during exposure.

Weight:

 Dose (mg/L air)  Gender  day 0  day 7  day 14
 2.3  male  215  261  287
 2.3  female  178  196  218
 15.4  male  196  -  -
 15.4  female  162  178  196
         
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Based on the results of this study, the LC50 for 1-hour exposure to DMEA was between 2.3 and 15.4 mg/l air.
Executive summary:

The acute inhalation toxicity of Dimethylethylamine (DMEA) was evaluated in a 1-hour, single-exposure study in rats. DMEA was initially administered to a single group of 10 male and 10 female Sprague Dawley rats via whole-body vapor exposure at concentrations between 2.3 and 15.4 mg/l. Mortality and clinical signs were evaluated daily over a 14-day observation period. Animals were weighted on days 0, 7 and 14.


Mortality was 0/20 at 2.3mg/l and 18/20 (10 males and 8 females) at 15.4 mg/l.All death occurred during exposure. During the 1-hour exposure, animals exposed to 2.3 mg/l air showed a slight increased salivation. Animals exposed to 15.4 mg/l air showed a decreased respiratory rate, gasping, slight apathy, eyelid closure, increased salivation, nasal secretion; furthermore, decreased response to touch, decreased reflex reactions (pain and auricle reflex), overall a poor general state was observed. In female rats trembling of the whole body and hunched posture were observed.


During observation period, 1 male exposed to 2.3 mg/l air showed alopecia after 13 days of observation.


After exposure to 15.4 mg/L air, surviving animals displayed gasping, slight apathy, lid closure, slight increased salivation, reduced pain reflex, tremor and twitching, piloerection. After 6 days they were without symptoms.


11 out of 18 dying animals showed diffuse alveolar emphysema; 1 animal presented atelectasis.


At necropsy, in the low dose group 9/20 animals showed a grey-red discoloration of the lung and sporadic paetechia were seen.


Based on the results of this study, the LC50 for 1-hour exposure to DMEA was between 2.3 and 15.4 mg/l air.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
2 300 mg/m³

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, OECD n°402 Guideline (1987, February 24th)
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sprague Dawley rats ICO: OFA-SD (IOPS Caw) supplied by Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 280+/-5g (males) and 214+/-8g (females)
- Fasting period before study: no
- Housing: individually in plycarbonate cages (35.5x23.5x19.3cm)
- Diet (e.g. ad libitum): ad libitum certified pelleted diet "rats - Mice sustenance ref.A04C" (U.A.R. 91360 Villemoisson sur Orge, France)
- Water (e.g. ad libitum): ad libitum drinkin water filtered by a 0.22µ fliter membrane (Société Millipore, 78140 Vélizy, France)
- Acclimation period: 5days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 1992-10-21 (sacrifice)
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6x8cm
- % coverage: approx. 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi occlusive dressing (Laboratoires de Pansements et d'Hygiène, 21300 Chenove, France) attached to a restraining bandage (Laboratoires 3M, 92245 Malakoff, France)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg taking in consideration that the specific gravity of the substance was 0.675
Duration of exposure:
24hours
Doses:
2000mg/kg (specific gravity=0.675)
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: clinical signs recorded frequently after application and then once daily, mortality checked twice daily, animals weighted on days 1, 5, 8 and 15
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
No death
Clinical signs:
None
Body weight:
Between days 1 and 5, a decrease in body weight in one male (N°05) was noted without subsequent consequence, probably due to stress caused by the experimental conditions.
Gross pathology:
No apparent abnormalities
Interpretation of results:
GHS criteria not met
Conclusions:
The LD0 by dermal application in rats of the test item Dimethylethylamine is higher than 2000mg/kg.
Executive summary:

The Acute dermal toxicity of Dimethylethylamine (DMEA) was evaluated in male and female Sprague Dawley rats according to OECD N°402 guideline.

Ten rats were applied dermally 2000mg/kg for 24hours and then observed during 14days. No control group was used.

Neither death nor clinical signs were recorded during the study showing that under these experimental conditions, the dermal LD0 of DMEA is higher than 2000 mg/kg in rats.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF test: DMEA was applied once for 24 hours to the clipped skin of the back and flank of White Vienna rabbits(area about 50 cm2) unchanged in a dose of 200 mg/kg. The treated area of skin was then covered with an inert foil, which was secured in position with adhesive tape. The bandage was removed after an exposure period of 24 hours; subsequently, the test substance was washed off with warm water or a mixture of water/Lutrol and dried with cellulose.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Weight at study initiation: male: 2.9 kg (mean); female: 3.2 kg (mean)
- Diet: Ssniff K, Standarddiaet, INTERMAST GMBH, Soest, ad libitum
- Water: tap water ad libitum

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm2
- Type of wrap if used: inert foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was washed off with warm water or a mixture of water/Lutrol and dried with cellulose.
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
200 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Mortality:
None of the tested 5 male or 5 female rabbits died within the observation period of 8 days.
Clinical signs:
24 h after application, the skin was irritated and within 8 days necrosis of the skin occurred.
Body weight:
no data
Gross pathology:
no abnormalities observed.

Single dose study; with existing data no exact calculation of LD50 possible.

Executive summary:

The acute dermal toxicity of Dimethylethylamine (DMEA) was evaluated in rabbits. DMEA was applied unchanged in a dose of 200 mg/kg for 24 hours to the clipped skin of the back and flank (area about 50 cm2) of groups of 5 male and 5 female Vienna rabbits at doses of 200 mg/kg in a semi-occlusive dressing for 24 hours.

 Following treatment, rats were observed daily and a gross necropsy examination was performed at the time of scheduled euthanasia (Day 8).

None of the tested 5 male or 5 female rabbits died within the observation period of 8 days.

No abnormality was observed at necropsy.

Under these experimental conditions, the dermal LD50 of DMEA is higher than 200 mg/kg in Vienna rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Regulation (EC) No 1272/2008, Annex VI Table 3.1

Acute Tox. 4 * H332

Acute Tox. 4 * H302

Self-classification according to EC Regulation 1272/2008 and GHS criteria

Oral: Acute tox. category 4 (LD50 594 mg/kg)

Inhalation: Acute tox. category 3 (2.3 < 1-h LC50 < 15.4 mg/l )

Dermal: not classified (LD0 > 2000 mg/kg)