Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jan 1970
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation of composition/type of substance insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
Method: single intravenous injection, test substance injected in physiological saline, 4 dose groups, 15 rats/group, observation time 7 days, determination of signs of intoxication, calculation of LD50
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity not specified
Specific details on test material used for the study:
Information from study report:
Mersolat-Paste (pH 8.25), technical grade

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Kirchborchen, Kreis Paderborn, Germany
- Weight at study initiation: 18-22 g

Administration / exposure

Route of administration:
intravenous
Vehicle:
physiological saline
Details on exposure:
INJECTION VELOCITY: 1 mL/min
Doses:
100, 150, 200, 250, and 350 mg/kg bw
No. of animals per sex per dose:
15 males
Details on study design:
- Duration of observation period following administration: 7 days
- Determination of signs of intoxication
Statistics:
Calculation of LD50 according to Litchfield and Wilcoxon (J. Pharmacol. Exper. Therap. 96, 99, 1949)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
195 mg/kg bw
95% CL:
173.1 - 219.6
Mortality:
Mortalities in dose groups: 100 mg/kg 0/15, 150 mg/kg 1/15, 200 mg/kg 8/15, 250 mg/kg 14/15, and 350 mg/kg 15/15. Deaths occurred immediately after injection.
Minimum lethal dose: 150 mg/kg
Clinical signs:
Animals were severly affected 1 to 10 minutes after injection. Typical signs of intoxication could not be noted. After 3 to 5 hours the animals returned to normal.
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Executive summary:

An LD50 -test was conducted with groups of male mice receiving a single intravenous administration of the test substance at doses of 100 to 350 mg/kg bw in ohysiological saline. The observation time was 7 days. Deaths occurred immediately after injection. The animals were severly affected 1 to 10 minutes after injection. Typical signs of intoxication could not be noted. Surviving animals returned to normal 3 to 5 hours post administration. The LD50 was calculated to be 195 mg/kg bw (95 % confidence level 173.1 -219.6 mg/kg).