Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1985 - January 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
The study was performed prior to the implementation of OECD Guidelines, but is in compliance with the principles described in OECD Guideline 401.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):N-(3-Aminopropyl)-Imidazol
- Physical state: liquid
- Analytical purity: 99.7 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Bieberach
- Housing: 5 animals per cage
- Fasting period before study: 16 h, water available ad libitum
- Diet (e.g. ad libitum): ad libitum (Liba-Labordiaet)
- Water (e.g. ad libitum): adlibitum, tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 C°
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
3160, 2150, 1470, 1000 mg/kg bw
No. of animals per sex per dose:
5
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:
1 780 mg/kg bw
Mortality:
Yes, see tables
Clinical signs:
Apathy, abnormal position, staggering, paresis, spastic gait, piloerection, diarrhea, poor general state
Body weight:
male: 189 g (mean)
female: 176 g( mean)
Gross pathology:
Animals that died:
General congestive hyperemia
Stomach: atonic, dark red with bloody contents (gastritis by corrosion)
Small and large intestines: dark red, bloody contents

Sacrifieced animals:
1 male animal slight intraabdominal adhesions. Organs of the remaining aniumals: no abnormalities detected

Any other information on results incl. tables

Mortality:

 

1 h

24 h

48 h

7 d

14 d

Dose (mg/kg)

male

female

male

female

male

female

male

female

male

female

3160

0

0

4

5

5

5

5

5

5

5

2150

0

0

3

5

3

5

3

5

3

5

1470

0

0

1

0

1

0

1

1

1

1

1000

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The study was performed comparable to OECD 401 with acceptable restrictions. Groups of 10 rats per dose were administered with 1000, 1470, 2150, and 3160 mg/kg bw. The acute LD50 was 1780 mg/kg in rats. Observed linical signs were apathy, abnormal position, staggering, paresis, spastic gait, piloerection, diarrhea, poor general state (1985, RL2).