Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Justification for data waiving:
other:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Amino-butan-1-ol
- Physical state: Liquid/ colorless, clear
- Analytical purity: 93.6 corr. a-%
- Lot/batch No.: 37794-117 (02/1302/24)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weigh)
- Fasting period before study:Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Deionized water
Doses:
2000 mg/kg bw, 300 mg/kg bw
No. of animals per sex per dose:
3 animals 2000 mg/kg bw
6 animals 300 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight,histopathology

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals of the 2000 mg/kg bw test group died at hour 5 or on study day 1 or 2.
No mortality occurred in both 300 mg/kg bw test groups.
Clinical signs:
2000 mg/kg (first test group): Impaired general state, poor general state in one animal, dyspnoea, piloerection, abdominal position in one animal, cowering position, stagger in two animals, exsiccosis in one animal, lack of defecation in one animal, salivation, sunken flanks in one animal
300 mg/kg (first test group): Impaired general state, dyspnoea, piloerection, reduced defecation in two animals, gasping in one animal
Body weight:
The mean body weight of the surviving animals increased within the normal range throughout the study period. The animals that died at day one or two showed weight reduction.
Gross pathology:
There were no macroscopic pathological findings in the surviving animals of both 300 mg/kg test groups sacrificed at the end of the observation period.
2000 mg/kg bw: Macroscopic pathological findings in all animals that died: Ascites: reddish clear or cloudy liquid; Stomach: gasified; red discolored; black discolored liquid contents; Glandular stomach: dark red discolored (no structure visible) or plane hemorrhage; Small intestine: red discolored; red or black-red discolored contents; Congestion of the kidneys; Dark or light spotted liver; Spleen: black or black-spotted discolored.

Any other information on results incl. tables

Mortality

 

Mortality

 

Dose (mg/kg bw):

2000

Sex:

female

Administration:

1

No. of animals:

3

Mortality (animals):

3

  

Mortality

 

Dose (mg/kg bw):

300

300

Sex:

female

female

Administration:

1

2

No. of animals:

3

3

Mortality (animals):

No mortality

No mortality

 

Under the conditions of this study the median lethal dose of 3-Amino-butan-1-ol after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Applicant's summary and conclusion