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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:
22. Aug 1978 - 11. Oct 1978
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test: 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 7 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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Trimethylamin 45 % (liquid)
CAS 75-50-3 (trimethylamine), purity not specified;

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 220 g (mean); female: 178 g (mean)
- Fasting period before study: 15 - 20 h before application
- Diet: Herlian MRH; Eggermann; Germany, ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
215, 316, 464, 681 and 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 2-4, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Animals were weighed before the experiment, and then on days 2-4, 7 and 13 of the experiment. Food was withheld from animals for a period of 15-20 hours before the application of the test substance, but water was available.  
Statistics:
A probit analysis was used to determine the LD50 value.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
766 mg/kg bw
95% CL:
654 - 901
Mortality:
No animals died in the three lowest groups, but 3/10 and 9/10 died in the two highest dose groups. No animals died in the first hour after administration of the test substance, but animals did die within the first 24 hours.
Clinical signs:
Animals of the two highest doses showed dyspnoea, apathy, aggressiveness, staggering, tremor, spastic gait, ruffled fur, diarrhea, exsiccosis, agglutinated snouts and poor general state.
Body weight:
See details in remarks on results.
Gross pathology:
Animals that died:
Heart: acute dilatation and congestive hyperemia;
Lung: slight acute swelling;
Liver: peripheral lobule marking;
Stomach: corroded mucous membranes of glandular stomach, bloody content;
Intestine: atonic, corroded mucous membranes, slight hydrothorax

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw)  1 h     24 h     48 h     7 days        14 days                    
   male  female male   female  male  female  male  female  male  female                    
 1000  0/5  0/5  4/5  4/5  4/5 5/5 4/5  5/5  4/5  5/5                    
681  0/5 0/5  0/5  1/5  0/5  1/5  1/5  2/5  1/5  2/5                    
 464  0/5  0/5  0/5  0/5  0/5  0/5  0/5  0/5  0/5  0/5                    
 316  0/5  0/5  0/5  0/5  0/5  0/5  0/5  0/5 0/5  0/5                    
 215  0/5  0/5  0/5 0/5  0/5   0/5  0/5  0/5  0/5  0/5                    

Mean weight (g):

 Dose (mg/kg)  gender  day 0  day 2-4  day 7  day 13              
 1000  male 260 212 269 324              
   female 190              
 681  male 190 170 217 259              
   female 170 160 188 208              
464  male 190 198 245 279              
   female 170 185 201 210              
316  male 190 211 249 254              
   female 170 189 203   214              
215  male 270 272 320 340              
   female 190 199 214 222              

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

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependend manner.
Executive summary:

An acute toxicity study was performed by BASF AG in 1979 comparable to the OECD Guideline 401. A test group consisting of 5 rats (strain: Sprague-Dawley)/sex was treated by single gavage application with an aqueous solution of the test substance trimethylamine. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The initial concentrations were 215, 316, 464, 681, and 1000 mg/kg bw. As effect level LD50 was 766 mg/kg bw. No animals died in the three lowest groups, but 3/10 and 9/10 died in the two highest dose groups. No animals died in the first hour after administration of the test substance, but animals did die within the first 24 hours. Animals of the two highest doses showed dyspnoea, apathy, aggressiveness, staggering, tremor, spastic gait, ruffled fur, diarrhea, exsiccosis, agglutinated snouts and poor general state. The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependend manner.