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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented study that meets basic sicentific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
5 mice per sex per group were intraperitoneally administered different doses of the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
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: 21.0 g (males); 20.7 g (females)
- Diet: Altromin R 1324 (Altroin GmbH, Lage, Germany)
no additional details reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
approx. 4515, 3075, 2540, 2092, 1430 and 973 mg/kg bw (calculated from 4640, 3160, 2610, 2150, 1470 and 1000 µL/kg bw, assuming test substance density of 0.973 g/mL)
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: the day of treatment, and daily thereafter
- Frequency of weighing: day 3, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 150 - < 2 610 other: µL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 092 - < 2 540 mg/kg bw
Based on:
test mat.
Remarks on result:
other: [Dose calculated with density = 0.973 g/mL]. All mice died treated with 2540 mg/kg bw. One mouse died treated with 2092 mg/kg bw.
Mortality:
- 2540 mg/kg bw: 10/10
- 2092 mg/kg bw: 1/10
Clinical signs:
dyspnoea, apathy, abdominal position, staggering, atonia, lost pain and corneal reflex, narcotic-like condition, tremor, spastic gait, cyanosis, exsiccosis, poor general condition
Body weight:
- 2092 mg/kg bw: (day 3) 26.3 g (males), 23.4 g (females); (day 7) 30.4 g (males), 24.3 g (females); (day 13) 33.7 g (males), 25.6 g (females)
- 1430 mg/kg bw: (day 3) 28.6 g (males), 25.8 g (females); (day 7) 31.4 g (males), 27.0 g (females); (day 13) 33.2 g (males), 25.4 g (females)
- 973 mg/kg bw: (day 3) 23.2 g (males), 24.6 g (females); (day 7) 27.0 g (males), 26.2 g (females); (day 13) 31.4 g (males), 25.4 g (females)
Gross pathology:
no precipitations found

Any other information on results incl. tables

Table 1: Acute i.p. toxicity: Mortality

Dose

Conc.

Sex

Time of death

µL/kg

%

1 h

24 h

48 h

7 d

14 d

4640

46.4

M

2/5

5/5

5/5

5/5

5/5

F

2/5

5/5

5/5

5/5

5/5

3160

31.6

M

0/5

5/5

5/5

5/5

5/5

F

0/5

5/5

5/5

5/5

5/5

2610

26.1

M

0/5

5/5

5/5

5/5

5/5

F

0/5

5/5

5/5

5/5

5/5

2150

21.5

M

0/5

1/5

1/5

1/5

1/5

F

0/5

0/5

0/5

0/5

0/5

1470

14.7

M

0/5

0/5

0/5

0/5

0/5

F

0/5

0/5

0/5

0/5

0/5

1000

10

M

0/5

0/5

0/5

0/5

0/5

F

0/5

0/5

0/5

0/5

0/5

Applicant's summary and conclusion

Conclusions:
LD50 for male and female >2092 - <2540 mg/kg bw (calculated with density = 0.973 g/mL)