Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Method: other: BASF-Test, experimental result
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): Dimethylamin, 40%-aqueous solution



- Name of test material (as cited in study report): Dimethylamin, 40%-ige waessrige Loesung

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Weight at study initiation: male 192 g (mean); female 160 g (mean)
- Diet: Herilan MRH-Haltung, Heinrich Eggersmann KG, Rinteln



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: dissolved in water with 0.5 % CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6.81 - 46.4 %
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
681, 1000, 1470, 2150, 3160 and 4640 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
ca. 1 000 mg/kg bw
Mortality:
No animal died in the lowest dose group. Four out of 10 died in the 1000 mg/kg group. All animals died in the four highest dose groups.
Clinical signs:
staggering, atony, spatic gait, exsiccosis, tremor, salivation, opisthotonus, poor general state, reduction in body weight, "morphinschwanz"
Gross pathology:
Animals that died:
Heart: acute dilatation and congestive hyperemia
Lung: slight emphysema
Gastro-intestinal tract: redness, bloody content
Liver: peripheral lobule marking


Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information
Executive summary:

In an oral acute toxicity study performed by BASF AG in 1980, DMA was administered to rats (test group consisting of 5 rats, strain: Sprague-Dawley/sex) by single gavage with an aqueous solution of the test substance. Observations for mortality and for clinical symptoms of toxicity were performed. 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 initial concentrations were 681, 1000, 1470, 2150, 3160 and 4640 mg/kg bw. As effect level the LD50 was considered to be around 1000 mg/kg bw. No animals died in the lowest groups, but 4/10 died in the dose group with 1000 mg/kg bw. All animals died in the 4 highest dose groups. Animals showed staggering, atony, spatic gait, exsiccosis, tremor, salivation, opisthotonus, poor general state, reduction in body weight, "morphinschwanz”. The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependent manner.