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EC number: 209-940-8 | CAS number: 598-56-1
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
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Endpoint summary
Administrative data
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
- 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:
- 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. - 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:
- other: no data
- Gross pathology:
- no data
- 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.
Referenceopen allclose all
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.
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 |
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
- 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. - 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 300 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- 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:
- other: None
- 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:
- other: 24 h after application, the skin was irritated and within 8 days necrosis of the skin occurred.
- Gross pathology:
- no abnormalities observed.
- 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.
Referenceopen allclose all
Single dose study; with existing data no exact calculation of LD50 possible.
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)
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