Reaction products of 4-hydroxy-2-butanone and ammonia and hydrogen

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

3-Amino-butan-1-ol

IUPAC Name:

3-Amino-butan-1-ol

Constituent 2

Reference substance name:

(R,S)-3-Amino-butan-1-ol

EC Number:

619-543-5

Cas Number:

2867-59-6

Molecular formula:

C4 H11 N O

IUPAC Name:

(R,S)-3-Amino-butan-1-ol

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 or test system 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- Fasting period before study:Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum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:

other: 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, saliv

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.