Registration Dossier

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

Constituent 1
Chemical structure
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:
slight piloerection for all animals immediately after dosing; slight piloerection 30 min after dosing (3/6);
Body weight:
nothing abnormal detected
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.

Applicant's summary and conclusion