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:
preGLP, pre-OECD guidelines, observation period 7 days

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

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
Test material form:
liquid
Details on test material:
Substance name: 1-Methylimidazol (flüssig)
Substance number: XVI/41

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: the test substance was administered as a 2-20% aqueous solution.
Doses:
200, 400, 800, 1000, 1250 and 1600 µl/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- 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. 1 144 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (original value is 1100 µl/kg bw)
Mortality:
200 and 400 µl/kg bw: no deaths after 7 days
800 µl/kg bw: 2/10 animals after 7 days
1000 µl/kg bw: 7/10 animals after 7 days
1250 µl/kg bw: 5/10 animals after 7 days
1600 µl/kg bw: all animals died after 7 days
Clinical signs:
Tonic cramps
Body weight:
Normal body weight growth
Gross pathology:
No abnormal findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria