1-Butanol, 3-amino-, (3R)-

Endpoint summary

Description of key information

LD50(oral,rat): > 300 <2000 mg/kg bw 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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:

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

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- Fasting period before study:Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

300 mg/kg bw

Quality of whole database:

The LD50 was between >300 <2000 mg/kg bw.

Additional information

There are no studies available for (R)-3 -Amino-butan-ol, only for the racemat 3-Amino-butan-1 -ol.

Acute oral

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423), doses of 2000 and 300 mg/kg bw of the test item 3-Amino-butan-1-ol (undiluted or preparations in deionized water) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females). 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 findings in the 300 mg/kg bw test group were impaired general state, dyspnoea, piloerection, reduced defecation, gasping. 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. The acute oral LD50 was calculated to be LD50, oral, rat > 300 < 2000 mg/kg bw. [BASF, 2014]

Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for classification or non-classification

EU classification according to Annex I of Directive 67/548/EEC: Xn, R22

According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 subtance is classified as Cat. 4 harmful if swallowed