2-ethylaminoethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 February 1978 to 14 March 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-comparabale, non-GLP proprietary study containing limited information but adequate for the purposes of hazard identification and classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Internal method comparable to OECD 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

ethylethanolamine

IUPAC Name:

ethylethanolamine

Constituent 2

Reference substance name:

2-ethylaminoethanol

EC Number:

203-797-5

EC Name:

2-ethylaminoethanol

Cas Number:

110-73-6

Molecular formula:

C4H11NO

IUPAC Name:

2-ethylaminoethanol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report):ethylethanolamine

- Physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no information
- Age at study initiation:
- Weight at study initiation: males approximately 250 g (group mean) and females 180 g (group mean)
- Fasting period before study: 15-20 h


IN-LIFE DATES: From: 1 February 1978 To: 14 March 1978

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.81; 10.00 and 14.70 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: distilled water
-

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

681, 1000 and 1470 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1-4, 7 and day 13
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight

Statistics:

median lethal dose for combined sexes obtained by interpolation method

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 073 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Calculated by the interpolation method

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 470 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 100% mortality at 1470 mg/kg bw; 30% mortality at 1000 mg/kg bw

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 470 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 100% mortality at 1470 mg/kg bw; 0% mortality at 1000 mg/kg bw

Effect levels 4

Sex:

female

Dose descriptor:

LD50

Effect level:

> 681 - < 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 60% mortality at 1000 mg/kg bw; 0% mortality at 681 mg/kg bw

Mortality:

All five males dosed at 1470 mg/kg died between day 1 and day 7 (3 died on Day 1). No male mortalities occurred at the lower two dose levels (1000 and 681 mg/kg ) . All five females dosed at 1470 mg/kg died between day 1 and day 7 (4 died on day 1). No female mortalities occurred at the lowest dose levels (681 mg/kg ) but three females died on day 7 after dosing at 1000 mg/kg.

Clinical signs:

other: Rats dosed at 1470 mg/kg showed clinical signs including apathy, yellow discoloured urine, dyspnoea, staggering, pilo-erection and poor general condition. No details are provided regarding times of onset or recovery. rats dosed at 1000 mg/kg showed clini

Gross pathology:

No information

Any other information on results incl. tables

The acute oral LD50 in the rat was found to be 1000 -1470 mg/kg bw and was calculated to be 1073 mg/kg bw (combined sexes).

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The overall median lethal oral dose for male and female rats was calculated to be 1073.38 mg/kg bw (Category 4 CLP classification)

Executive summary:

Groups of five male and five female SD rats were dosed by oral gavage at levels of 681, 1000 or 1470 mg/kg bw and observed for 14 days. All rats dosed at 1470 mg/kg by died within 7 days, 3 female rats died at 1000 mg/kg and there were no mortalities in the low dose group. The acute oral LD50 is therefore calculated to be 1073 mg/kg bw.