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Diss Factsheets

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:
05. Mar 1975 - 02. Apr 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientificially valid study, comparable to guideline, but not according to current standards or GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethylisopropylamine
EC Number:
213-635-5
EC Name:
N,N-dimethylisopropylamine
Cas Number:
996-35-0
Molecular formula:
C5H13N
IUPAC Name:
dimethyl(propan-2-yl)amine
Details on test material:
- Name of test material (as cited in study report): N,N-Dimethylisopropylamin
- Analytical purity: 99 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: about 12 weeks
- Weight at study initiation: 162 - 177 g (average weight)
- Fasting period before study: 16 hours
- Housing: 5 per cage
- Diet: Altromin R 1321; Altromin GmbH, Lage/Lippe, Germany, ad libitum
- Water: Fully demineralized water ad libitum each workday; tap water ad libitum on public holidays.
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26 °C
- Humidity (%): 45 - 75 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
316, 464, 681, 825 and 1000 µl/kg bw corresponding to 228, 334, 490, 594 and 720 mg/kg bw; based on a density of 0.72 g/ml at 20°C.
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 3, 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 684 mg/kg bw
Mortality:
720 mg/kg: 1 male died within 24 h and 3 males within 7 days. 3 femaled died within 48 h.
594 mg/kg: 2 males died within 48 h.
Clinical signs:
other: 594 mg/kg and 720 mg/kg bw: dyspnoea, staggering, apathy and abdominal position immediately after application. Dyspnoea, apathy, poor general state and aggressiveness during the following observation days. 490 mg/kg bw: staggering, apathy, slightly incr
Gross pathology:
490 mg/kg bw, 594 mg/kg bw and 720 mg/kg bw:
Heart: acute dilation and congestive hyperemia,
Abdominal cavity: adhesion of organs and peritoneum with the stomach, organized perforation of the stomach in one animal at 1000 mg/kg,
Glandular stomach: diffuse red discoloration with hemorrhagic ulcers, corrosive scar in the stomach,
Intestine: reddish content.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg )  Conc.  Gender  1 h  24 h  48 h  day 7  day 14  
 720  15  male  0/5 1/5 1/5 3/5 3/5  
 720 15  female  0/5 2/5  3/5  3/5 3/5  
 594  6  male 0/5  0/5  0/5  0/5  0/5  
 594 6  female  0/5  2/5 2/5  2/5 2/5  
 490 6  male  0/5  0/5  0/5  0/5  -  
 490  6  female  0/5  0/5  0/5  0/5  -  
 334 6  male 0/5 0/5  0/5 0/5 -  
 334  6  female  0/5 0/5  0/5 0/5 -  
 228  3  male  0/5  0/5  0/5  0/5 -  
 228  3  female  0/5 0/5  0/5  0/5 -  

Weight (g):

 Dose (mg/kg)

 Gender  day 0  day 3  day 7  day 13    
 720  male  168 154  204 255     
 594  male  166 137 176 203     
490  male 180 180 196    
334  male 176 219 206    
228 male  195 182 235  -    
               
 720 female  164 156 147 170     
 594  female 163 159 169 189    
490  female  157 170 157 -    
 334  female 160 177 177 -    
 228  female 164 149 179 -    

Harmful if swallowed. There is indication that the test substance causes local irritation to exposed tissue.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 value was 684 mg/kg bw.
Executive summary:

The acute oral toxicity of dimethylisopropylamine was evaluated in a study conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated at dose levels of 228, 334, 490, 594 and 720 mg/kg bw by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was 684 mg/kg bw.