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Diss Factsheets

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: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Single intraperitoneal application of test material at doses of 50, 200 and 700 mg/kg bw followed by a 14-day examination period. Investigation of mortality, clinical signs and body weight development. Gross pathology of sacrificed animals as well as animals that died.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Constituent 1
Reference substance name:
preparation containing CAS 78181-99-4
IUPAC Name:
preparation containing CAS 78181-99-4
Details on test material:
Please refer the confidential details on test material

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Weight at study initiation: males 24 - 26 g, females 24 g
- Fasting period before study: 15 h - 20 h before administration
- Diet: Herilan MRH-Haltung; H. Eggersmann KG

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
Single intraperitoneal application of test material
Doses:
50, 200, 700 mg/kg bw
No. of animals per sex per dose:
5 mice
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 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:
> 50 - < 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1% significance level
Mortality:
The mortality incidences (sexes combined) were:
700 mg/kg bw: 10/10
200 mg/kg bw: 10/10
50 mg/kg bw: 0/10

For details, see table below
Clinical signs:
700 mg/kg bw: apathy, staggering, twitching, convulsions, exophthalmos, shortness of breath, poor general state
200 mg/kg bw: dyspnoea, apathy, staggering, tremor, cyanosis, exsiccosis, poor general state
50 mg/kg bw: dyspnoea, apathy, staggering, piloerection, poor general state
Body weight:
The animals surviving until the day of scheduled necropsy (low dose group only) showed body weight gain during the study period.
For details, see table below
Gross pathology:
Animals that died: staining of abdominal cavity
Sacrificed animals: slight intraabdominal agglutination

Any other information on results incl. tables

Mortality:

Dose (mg/kg bw)

700

200

50

 

 

 

 

Males: Number of animals

5

5

5

Dead animals after:

 

 

 

1 h

5

2

0

1 d

5

5

0

2 d

5

5

0

7 d

5

5

0

14 d

5

5

0

 

 

 

 

Females: Number of animals

5

5

5

Dead animals after:

 

 

 

1 h

5

5

0

1 d

5

5

0

2 d

5

5

0

7 d

5

5

0

14 d

5

5

0

 

Mean weight (g):

Dose (mg/kg bw)

700

200

50

 

 

 

 

Males: Beginning of test

26

24

24

 

 

 

 

After

2-4 d

 

 

28.6

 

7 d

 

 

30.4

 

13 d

 

 

31.4

 

 

 

 

Females: Beginning of test

24

24

24

 

 

 

 

After

2-4 d

 

 

26.6

 

7 d

 

 

28.2

 

13 d

 

 

28.6

 

LD50 determination:

Doses

(mg/kg bw)

No. of animals

Dead animals after 14 days

Mortality

(%)

Doses used for calculation

50

10

0

0

*

200

10

10

100

*

700

10

10

100

 

 

 

 

 

 

LD50 value

> 50 mg/kg bw

(1% siginificance level)

LD50 value

< 200 mg/kg bw

(1% siginificance level)

 

Applicant's summary and conclusion