DL-2-aminopropan-1-ol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Test material

Test material information

1

Reference substance name:

DL-2-aminopropan-1-ol

EC Number:

228-207-3

EC Name:

DL-2-aminopropan-1-ol

Cas Number:

6168-72-5

Molecular formula:

C3H9NO

IUPAC Name:

2-aminopropan-1-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

175, 550, 1750, 5000 mg/kg

No. of animals per sex per dose:

1 to 4

Control animals:

no

Details on study design:

An initial limit dose of 5000 mg/kg was administered to one healthy female rat by oral gavage.
Pu~ to mortality in this animal, the study proceeded to the Main Test. Using the default starting
level of 175 mg/kg and following the Up and Down procedure, nine additional females were
dosed at levels of 175, 550, 1750 or 5000 mg/kg. Females were selected for the test because they
are frequently more sensitive to the toxicity of test compounds than males. All animals were
observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14
days after dosing or until death occurred. Body weights were recorded prior to administration
(initial) and again on Days 7 and 14 (terminal) following dosing or after death. Necropsies were
performed on all animals.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 750 mg/kg bw

95% CL:

>= 652 - <= 2 690

Remarks on result:

other: was also the LDLo

Mortality:

Mortality rate at each dose-level (mg/kg):
2/2 at 5000 within one day of exposure
3/4 at 1750 within one day of exposure
0/3 at 550
0/1 at 175

Clinical signs:

other: 1750: Prior to death, one animal was hypoactive and exhibited irregular respiration and ataxia. 5000: Prior to death, both animals exhibited irregular respiration and/or ocular discharge. No clinical signs in other animals.

Gross pathology:

1750: Gross necropsy revealed distention and/or discoloration of the stomach and intestines and/or a fluid filled stomach.
5000: Gross necropsy of the decedents revealed discoloration of the intestines and/or liver and distention of the stomach and/or intestines.
No gross abnormalities in other animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

The acute oral LD50 was estimated to be 1750 mg/kg of body weight in female rats with a 95% confidence interval of 651.9-2690 mg/kg.