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:
comparable to guideline study with acceptable restrictions
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

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 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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Dimethylimidazol
- Physical state: solid

Test animals

Species:
rat
Strain:
other: US-rats
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2% or 20% v/v
Doses:
200, 800, 1000, 1250, 1600 mg/kg bw
No. of animals per sex per dose:
5-10
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: clinical signs
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 300 mg/kg bw
Based on:
test mat.
Mortality:
0/10 animals died at 200 mg/kg bw
1/10 animals died at 800 mg/kg bw
2/10 animals died at 1000 mg/kg bw
4/10 animals died at 1250 mg/kg bw
14/20 animals died at 1600 mg/kg bw
deaths occured within day 1-2
Clinical signs:
On the day of administration: partly/slight staggering, shaking, slight dyspnoea, mild cramps, trembling.
On the following days: apathy, rough coat, sometimes bloody crusted nose and eyes.
The surviving aninmals were without findings within 1-6 days.
Body weight:
no data
Gross pathology:
stomach filled with test substance and bleeding of gastric mucosa in the dead animals, organs of the surviving animals without findings

Applicant's summary and conclusion