(2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride

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: guideline-conform study (no GLP; TS purity not specified)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

May 21, 1981

GLP compliance:

no

Remarks:

well documented study with quality controlled data

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride

EC Number:

278-860-3

EC Name:

(2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride

Cas Number:

78182-00-0

Molecular formula:

C7H18NO2.Cl

IUPAC Name:

3-hydroxy-N-(2-hydroxyethyl)-N,N-dimethylpropan-1-aminium chloride

Details on test material:

- Name of the test substance used in the study report: Dimethylaminopropanol + 1 EO Hydrochlorid
- Physical state: solid
No additional details provided

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: from Dr. K. Thomae GmbH, Biberach
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: animals with a comparable weight (+/- 20%) were used (see Table 1).
- Fasting period before study: 16 hours without diet, but with water
- Housing: 5 animals per cage (type V-II-A-steel, DK-III)
- Diet (e.g. ad libitum): Ssniff R; Fa. Ssniff, Versuchstierdiaeten; 4470 Soest
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Aqua dest.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50.0, 31.6 and 21.5%, repectively in the high, mid and low dose groups
- Amount of vehicle (if gavage): 10 ml/kg bw

Doses:

2150, 3160 and 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical symptom observation < 15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after administration, then once daily; check for moribund or dead animals 2 times per working day and 1 time on weekends/public holidays; body weight determination before treatment (day 0), then on days 3/4, 7 and 13.
- Necropsy of survivors performed: yes; fasting 16 hours before sacrifice with CO2, necropsy with macroscopic examination. Necropsy of all animals found dead as soon as possible.

Statistics:

Mean body weights were calculated

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 2150 and 3160 mg/kg bw dose groups: no deaths; 5000 mg/kg bw dose group: 2/5 deaths.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 3 160 - < 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 2150 and 3160 mg/kg bw dose groups: no deaths; 5000 mg/kg bw dose group: 4/5 deaths.

Mortality:

- Male animals: 2150 and 3160 mg/kg no deaths after 14 days; 5000 mg/kg 2/5 deaths within 1 hour after treatment.
- Female animals: 2150 and 3160 mg/kg no deaths after 14 days; 5000 mg/kg 4/5 deaths within 1 hour after treatment.

Clinical signs:

Only in the high dose group (generally 15 min to 4 hours after treatment:
- Male animals: dyspnoea, apathy, staggering, convulsion, diarrhea, poor general state.
- Female animals: dyspnoea, apathy, abnormal position, staggering, convulsion, tremor, ruffled fur, diarrhea, cyanosis, breathlessness, poor general state.

Body weight:

No adverse effects observed for survival animals (see Table 1)

Gross pathology:

- Animals that died (males and females; highest concentration): general congestive hyperemia; intestine: atonic, diarrheic content.
- Sacrificed animals: nothing abnormal detected.

Any other information on results incl. tables

Table 1: Mean body weights

Dose groups (mg/kg bw)	Sex	Mean body weights (g) at indicated time period after treatment
		0	3/4	7	13
5000	Males	190	209	242	276
	Females	190	207	222	235
3160	Males	160	211	235	263
	Females	180	210	215	233
2150	Males	160	203	222	259
	Females	180	210	221	240