2-(hydroxymethylamino)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data from secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Robust Summaries for Ethanol, 2-(Hydroxymethylamino) (CAS No. 34375-28-5)

Author:

(HPVIS) EPA

Year:

1986

Bibliographic source:

U.S Environmental Protection Agency/ High Production Volume Information System (HPVIS) 1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of Ethanol, 2-(hydroxymethylamino) in Sprague-Dawley rats.

GLP compliance:

no

Test type:

other: No data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(hydroxymethylamino)ethanol

EC Number:

251-974-0

EC Name:

2-(hydroxymethylamino)ethanol

Cas Number:

34375-28-5

Molecular formula:

C3H9NO2

IUPAC Name:

2-[hydroxy(methyl)amino]ethanol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 2-(hydroxymethylamino)ethanol
- Molecular formula : C3H9NO2
- Molecular weight :91.11 g/mole
- Substance type: Organic
- Physical state:Liquid
- SMILES: OCCNCO

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2-(hydroxymethylamino)ethanol
- Molecular formula (if other than submission substance): C3H9NO2
- Molecular weight (if other than submission substance): 91.11 g/mole
- Substance type: Organic
- Physical state: Solid
- SMILES: OCCNCO

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Age at study initiation: 6-8 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Distilled

Details on oral exposure:

Not applicableVEHICLE
- Concentration in vehicle: 750, 1250, 2100 and 3500 mg/kg (for males), 2500, 3150, 4000 and 5000 mg/kg (for females in first study) and 600, 1200, 1800 and 2400 mg/kg (for females in second study)
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Distilled water


DOSAGE PREPARATION (if unusual): The test material was administered orally in a single dose by means of gavage at a constant dose volume of 10 ml/kg.

Doses:

For male: 750, 1250, 2100 and 3500 mg/kg
For female: 2500, 3150, 4000 and 5000 mg/kg
For female in second study: 600, 1200, 1800 and 2400 mg/kg

No. of animals per sex per dose:

Total: 60
male:
750 mg/kg: 5
1250 mg/kg: 5
2100 mg/kg: 5
3500 mg/kg: 5
For female:
2500 mg/kg: 5
3150 mg/kg: 5
4000 mg/kg : 5
5000 mg/kg : 5
For female in second study:
600 mg/kg: 5
1200 mg/kg: 5
1800 mg/kg: 5
2400 mg/kg: 5

Control animals:

not specified

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently on the day of dosing and for 14 days following. They were weighed immediately prior to dosing, 7 days after dosing and at death or sacrifice at the end of the 14 day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

The LD50 values were calculated based on the mortality pattern by probit analysis (Finney, 1971).

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 620 mg/kg bw

Based on:

test mat.

95% CL:

1 069 - 2 455

Remarks on result:

other: 50 % mortality observed

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 956 mg/kg bw

Based on:

test mat.

95% CL:

1 110 - 3 093

Remarks on result:

other: 50 % mortality observed

Mortality:

In male rat, when treated with 3500 mg/kg bw, all animals died,
When treated with 2100 mg/kg bw, 4 animals died.
When treated with 1250 mg/kg bw, 1 animal died
when treated with 750 mg/kg bw, no morality observed.
In female rats, when treated with 2500, 3150, 4000 and 5000 mg/kg, all animal died in study.
When treated with 2400 mg/kg bw, 4 animals died.
When treated with 1800 mg/kg bw, 2 animals died.
When treated with 600 and 1200 mg/kg bw, no morality observed.

Clinical signs:

other: Hyperkinesias, sedation, coma, prostration, piloerection, soiled coat, ataxia and haemodaccryorrhea were observed at 0.5 hr to 4 days after dosing.

Gross pathology:

In the first study, red stained fluid in the gut in premature decedents and in post mortem at 14 day, gas-filled gut and stomach were observed in one male rat. In the second study, No abnormalities were observed in treated female rat.

Other findings:

No data available

Any other information on results incl. tables

Mortality by dose and sex (first study):

Dose Level (mg/kg bw)	Male	Female
750	0/5	-
1250	1/5	-
2100	1/5	-
2500	-	5/5
3150	-	5/5
3500	5/5	-
4000	-	5/5
5000	-	5/5

 

Mortality by dose (female only, second study):

Dose Level (mg/kg bw)	Female
600	0/5
1200	0/5
1800	2/5
2400	4/5

 

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Conclusions:

LD50 was considered to be 1620 mg/kg (1069-2455) for amle and 1956 mg/kg (1110-3093) for female when Sprague-Dawley male and female rat were treated with 2-[hydroxy(methyl)amino]ethanol orally by gavage.

Executive summary:

In a Acute oral toxicity study, Sprague-Dawley male and female rat were treated with 2-[hydroxy(methyl)amino]ethanol in the concentration of 750, 1250, 2100 and 3500 mg/kg (for males), 2500, 3150, 4000 and 5000 mg/kg (for females in first study) and 600, 1200, 1800 and 2400 mg/kg (for females in second study) in Distilled water orally by gavage. In male rat, all animals died at 3500 mg/kg bw, 4 animals died at 2100 mg/kg bw, 1 animal died at 1250 mg/kg bw and no morality observed at 750 mg/kg bw. In female rats, all animal died at 2500, 3150, 4000 and 5000 mg/kg within 4 hours to 1 day. Due to the unexpected mortality in the first study, study was repeat using lower dose levels for females only. 4 animals died at 2400 mg/kg bw. 2 animals died at 1800 mg/kg bw and no morality observed at 600 and 1200 mg/kg bw within 1 day. Hyperkinesias, sedation, coma, prostration, piloerection, soiled coat, ataxia and haemodaccryorrhea were observed at 0.5 hr to 4 days after dosing. In the first study, generally lower body weight were observed than expected with one male rat having lost weight after 7 days, and another having lost weight at the end of the 14-day observation period. No effect on body weight was observed in second study. In the first study, red stained fluid in the gut in premature decedents and in post mortem at 14 day, gas-filled gut and stomach were observed in one male rat. In the second study, No abnormalities were observed in treated female rat. Therefore, LD50 was considered to be 1620 mg/kg (1069-2455) for amle and 1956 mg/kg (1110-3093) for female when Sprague-Dawley male and female rat were treated with 2-[hydroxy(methyl)amino]ethanol orally by gavage.