1H-imidazole-1-propylamine

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

1H-imidazole-1-propylamine

EC Number:

225-730-9

EC Name:

1H-imidazole-1-propylamine

Cas Number:

5036-48-6

Molecular formula:

C6H11N3

IUPAC Name:

3-(1H-imidazol-1-yl)propan-1-amine

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 or test system 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:

other: Apathy, abnormal position, staggering, paresis, spastic gait, piloerection, diarrhea, poor general state

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).