2-(methylamino)ethanol, compound with sulphur dioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable non-GLP study, similar to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Principles of method if other than guideline:

BASF test. The study was conducted before the OECD guideline 401 was first adopted.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(methylamino)ethanol, compound with sulphur dioxide

EC Number:

244-169-0

EC Name:

2-(methylamino)ethanol, compound with sulphur dioxide

Cas Number:

21049-70-7

Molecular formula:

C3H9NO.xO2S

IUPAC Name:

(oxo-λ⁴-sulfanylidene)oxidane; 2-(methylamino)ethan-1-ol

Details on test material:

- Name of test material: Kauramin-Härter CE 5162 flüssig; N-Methyläthanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 49.4 %, Sulfur dioxide: 29.5 %, Water: 21.1 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: purchased from a breeder (Wiga)
- Age at study initiation: young adult
- Weight at study initiation (range of group mean values): 200 g (males), 160-180 g (females)
- Fasting period before study: 15-20 hours prior to the single administration
- Diet: Herilan MRH-Haltung (H. Eggersmann KG, Germany)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 215, 316, 383, 464, 500 mg/mL
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED:
The concentrations of the dose formulations were adjusted to achieve the same dose volume, 10 mL/kg bw.

Doses:

2150, 3160, 3830, 4640, 5000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the frequency of observations was not reported; body weight was determined once prior to treatment, on days 2-5 (males) or 2-4 (females), day 7 and days 12-13 (only mean values reported)
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of premature decedents

Statistics:

Probit analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 891 mg/kg bw

Based on:

test mat.

95% CL:

3 418 - 4 338

Remarks on result:

other: slope factor: 1.26

Mortality:

The mortality incidences after 14 days were:
0/10 at 2150 mg/kg bw
2/10 at 3160 mg/kg bw
5/10 at 3830 mg/kg bw
7/10 at 4640 mg/kg bw
9/10 at 5000 mg/kg bw

Clinical signs:

other: Dyspnoea, apathy and poor general condition were seen at all dose levels. Exsiccosis, ruffled fur, markedly yellow urine and atony were observed at 3160 mg/kg bw and above. Further clinical findings included diarrhoea at 3160 mg/kg bw, spastic gait at 316

Gross pathology:

There were no macroscopic abnormalities noted at scheduled necropsy.
Premature decedents showed acute left and right heart dilatation, pulmonary edema, partial inflation of the lungs, single cases of reddened glandular stomach (epithelium) and atony and diarrhoeic content of the intestine as well as peripheral marks on liver lobules.