Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented study that meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Mice were intraperitoneally administered a single dose of the test substance. The animals were observed for mortality and clinical signs of toxicity and necropsied at death or after the observation period of 14 days.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ivanovas
- Weight at study initiation (mean): 20.3 g (males), 19.5 g (females)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: ethyl acetate
Doses:
1474, 2150, 3160, 3830, 4640, 5620, 6810 and 10000 mg/kg bw (50% solution)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on day 0, daily in the following days
- Frequency of weighing: day 0, 3, 7 and 11-13
- 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. 850 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Corresponding to 1700 mg/kg bw of the applied 50% solution.
Mortality:
- 1474 mg/kg bw: 3/10
- 2150 mg/kg bw: 8/10
- 3160 mg/kg bw: 7/10
- 3830, 4640, 5620, 6810 and 10000 mg/kg bw: 10/10
Clinical signs:
dyspnoea, apathy, staggering, bad general state, lateral position in some animals, atonia, narcose-like state, tremor, exsiccose, spastic gait, lagrimation
Gross pathology:
substance residues and adhesions in stomach and abdomen

Any other information on results incl. tables

Table 1: Mortality and mean body weight

Dose (mg/kg bw)

Sex

Mean body weight (g)

Mortality

Day 0

Day 3

Day 7

Day 11-13

1 h

24 h

48 h

7 d

14 d

10000

M

21

-

-

-

5

5

5

5

5

F

18

-

-

-

5

5

5

5

5

6810

M

19

-

-

-

4

5

5

5

5

F

20

-

-

-

5

5

5

5

5

5620

M

18

-

-

-

3

4

4

5

5

F

18

17

-

-

4

4

4

5

5

4640

M

18

16

-

-

2

4

4

5

5

F

19

17

-

-

3

4

4

5

5

3830

M

18

-

-

-

0

4

4

5

5

F

19

17

-

-

1

3

4

5

5

3160

M

17

17

20

20

0

0

0

3

3

F

19

20

25

26

1

2

3

4

4

2150

M

26

21

-

-

0

0

1

5

5

F

20

20

21

21

0

1

2

3

3

1474

M

26

25

30

31

0

1

1

3

3

F

20

22

24

25

0

0

0

0

0

Applicant's summary and conclusion