Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-379-2 | CAS number: 68815-51-0
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:
- 2 007
- 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
- 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
Constituent 1
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.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
