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Administrative data

Description of key information

The acute oral LD50 was 1780 mg/kg in rats.

Studies of acute dermal and inhalative toxicity of 1H-imidazole-1-propylamien are not available. According to the REACh regulation, annex VII+VIII, 8.5 column 2, a acute dermal and inhalative study does not need to be conducted due to the corrosivity of 1H-imidazole-1-propylamien are not available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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

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

 

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).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 780 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity study was performed comparable to OECD401 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 clinical signs were apathy, abnormal position, staggering, paresis, spastic gait, piloerection, diarrhea, poor general state (1985, RL2).

Studies of acute dermal and inhalative toxicity of 1H-imidazole-1-propylamien are not available. According to the REACh regulation, annex VII+VIII, 8.5 column 2, a acute dermal and inhalative study does not need to be conducted due to the corrosivity of 1H-imidazole-1-propylamien are not available.

Justification for classification or non-classification

GHS classification according to Annex I of the Regulation EC/1272/2008: Oral route: Acute Category 4, H302, based on the available data.

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