3-[(2-hydroxyethyl)amino]propanol

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other: GLP compliant, guideline study, available as unpublished report no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2-hydroxyethyl)amino]propanol

EC Number:

242-978-3

EC Name:

3-[(2-hydroxyethyl)amino]propanol

Cas Number:

19344-29-7

Molecular formula:

C5H13NO2

IUPAC Name:

3-[(2-hydroxyethyl)amino]propan-1-ol

Details on test material:

- Name of the test substance used in the study report: 3-(2-hydroxyethylamino)-1-propanol
- Physical state: Liquid, viscous, achromatic
- Storage condition of test material: Room temperature
- Analytical purity: 99.3 g/100 g
- Lot/batch No.: ABL.NO. 61-1853

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Biberbach, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 150 - 300 g (± 20% of the mean weight)
- Fasting period before study: At least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in stainless steel wire mesh cages, type DK-33
- Diet: Kliba-labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: tap water, ad libitum
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Form of administration: solution
- Concentration in vehicle: 20 g/100 mL
- Administration volume: 10 mL/kg
- Justification for choice of vehicle: The aqueous formulation corresponds to the physiological medium.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded shortly before administration, weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each working day. A check for any dead or moribund animal was made twice each working day and once on weekends and on public holidays.
- Necropsy of survivors performed: Yes, necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Males: Impaired general state, dyspnea, staggering, and piloerection on day 1. Females: Impaired general state, dyspnea, spastic gait, and piloerection from 3 hour to 5 hours after administration of the test substance.

Gross pathology:

No pathological findings noted

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information