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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
(2-hydroxyethyl)(3-hydroxypropyl)dimethylazanium 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 levelsopen allclose all
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.
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

Applicant's summary and conclusion