Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1955
Report Date:
1955

Materials and methods

Principles of method if other than guideline:
To estimate the LD50 value, mice were administered the test substance intraperitoneally and kept for observation for 7 days. A solution of the test substance was prepared on a weight/volume basis. The concentrations were varied to allow administration of a constant volume of 0.015 mL/g bw.
GLP compliance:
no
Remarks:
performed prior to GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): R-9
- Lot/batch No.: 396658R-9

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 15 g, on average

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: A solution of the test substance with an unknown vehicle was prepared
Details on exposure:
A solution of the test substance was prepared on a weight/volume basis. The concentrations were varied to allow administration of a constant volume of 0.015 mL/g bw.
Doses:
100, 250, 500, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
10 per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
Statistics:
The approximate LD50 doses were estimated by the method of Miller and Tainter, Proc. Soc. Exper. Biol. and Med., 1944; 57: 261.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Range: 400 ± 40 mg/kg bw
Mortality:
In the 100, 250, 500, 1000 and 2000 mg/kg bw dose groups, the mortality was 0, 1, 7, 9 and 10, respectively (see table 1).

Any other information on results incl. tables

Table 1: Mortality per dose group administered the test substance

Dose (mg/kg)

Number of animals treated

Mortality

100

10

0/10

250

10

1/10

500

10

7/10

1000

10

9/10

2000

10

10/10

Applicant's summary and conclusion