9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol

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 study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol

EC Number:

272-379-2

EC Name:

9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol

Cas Number:

68815-51-0

Molecular formula:

C18 H34 O2 . C4 H12 N2 O

IUPAC Name:

2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid

Details on test material:

- Name of test material (as cited in study report): Kerocom F 100; Reference 07/0395;
- Physical state: brown solid paste
- Analytical purity: 100%
- Purity test date: 18.06.07
- Lot/batch No.: GV33754-L2927
- Storage condition of test material: room temperature, under protection from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, France
- Age at study initiation: 7 weeks
- Weight at study initiation: mean body weight 198.1 g
- Fasting before study: yes, no further data
- Fasting after study: 3-4 hours
- Housing: rat of three per cage in polypropylene cages
- Diet: pelleted complete diet supplied by SAFE (France)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Doses:

5; 50; 300; 2000 mg/kg;

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: within 30 min after gavage, at 1, 2, 3, 4 hours, and day 1-14 once daily
- Frequency of weighing: day -1; 0, 3, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: slight piloerection for all animals immediately after dosing; slight piloerection 30 min after dosing (3/6);

Gross pathology:

nothing abnormal detected

Any other information on results incl. tables

Because of the stepwise procedure of dosing and the lacking toxicity observed in the 2000 mg/kg dosing group no additional animals have been dosed with lower doses.