Registration Dossier
Registration Dossier
Diss Factsheets
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: 205-271-0 | CAS number: 136-99-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 15 november 2000 and 14 December 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Releability 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- before 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
- EC Number:
- 205-271-0
- EC Name:
- 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
- Cas Number:
- 136-99-2
- Molecular formula:
- C16H32N2O
- IUPAC Name:
- 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
- Test material form:
- other: solid
- Details on test material:
- -
Constituent 1
- Specific details on test material used for the study:
- Test material information:
2-(2-undecyl-4,5-dihydro-1H-imidazol-1-yl)ethanol
Specific details on test material used for the study:
name: Lauryl-hydroxyethylthylimidazoline
CAS-Number: 136-99-2
Content >85%
Appearance: white solid
Storage conditions: darkness at approximately 20°C In a fume
Impurities (identity and concentrations):
Composition of test material, percentage of components: >85%
Lot/batch No.: Batch 1
Expiration date of the lot/batch: August 29, 2002
Stability and homogeneneity in the vehicle: is guaranteed for 1 hour
Test animals
- Species:
- other: Rat common species
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Rat
Species: Sprague-Dawley
Strain: HSD: Sprague-Dawley SD
Origin HARLAN WINKELMANN Gartenstr. 27, 33178 Borchen
SPF breeding colony
- Source:
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 6-10 weeks
-Randomization: Randomization schemes 2000.0412, 2000.0413, 2000.0571.2000.0572
-Animal maintenance: In fully air conditionned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Weight at study initiation: male animals: mean= 195 g(=100%)
S=±6.5g
min=185 g 8-5.1%)
max=205g(+5.1%)
n=10
female animals: mean=182g (=100%)
S=±5.5 g
min=174g(-4.4%)
max=190g(+4.4%)
n=15
-Food: Ssniff® R/M-H (V1534), ad libitum
-Withdrawal of food: from about 16 hours before to 3-4 hours after treatment
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
Animal identification: fur marking with KMn04 and cage numbering.
- Acclimation period: at least 7 daya
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): relative Humidity: 50±20%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours daily
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- Preparation of the testb compound was emulsified in the statd concentrations In sesame oil and distributed homogeneously by means of a magnetic stirrer. The stability and the homogenity of the test substance in the vehicle was determined by analytical methods.
- Doses:
- 315,500 and 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5 animals per sex per dose (315 and 2000mg/kg b.w.)
5 females (500 mg/kg b.w.) - Control animals:
- no
- Details on study design:
- The test substance preparations were administrated by gavage to fasted animals at the stated dosage. The observation periode following treatment lasted for 14 days. Symptoms and lethality were recorded twice every day ( in the morning and in the afternoon). On weekends and public holidays only once. Animlas found dead were dissected as soon as possible and examined for macroscopically visible changes. During this time the animals were weight weekly. At the end of the observation period surviving animals were killed by carbon dioxide asphyxiation dissedsd and also examined for macroscopically visible changes.
- Statistics:
- The LDso, the 95 % limits of confidence and the equation of the probitline were established in female
animals on the basis of the lethality rates by probit analysis.
(method of FIELLER and SIDAK, programs supplied by IS Research, Aventis Pharma Deutschland
GmbH).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 448.9 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Please see "any other information section"
- Clinical signs:
- The following clinical signs were observed after the administration of the test material:
- hypoactivity, stupor, squatting posture, stilted, uncoordinated and ataxic gait, irregular respiration,
painting, gasping, respiratory sounds, drawn in flanks,
bristling coat, narrow palpebral fissures and trembling. - Body weight:
- Development of bodyweight was not impaired.
- Gross pathology:
- Macroscopic examination of the animals found dead revealed the following findings:
Black discolored spleen, stomach filled with gas, diffuse reddening of the stomach mucosa and deta
chment of the stomach and small intestine mucosa as well as blood in the small intestine, small int
estine filled with dark yellow mucous, urine bladder filled with dark red fluid, positive test of blood in u
rine, abdominal cavity filled with light red fluid.
The animals killed at the end of the observation period showed no macroscopically visible changes.
Any other information on results incl. tables
Under the conditions described above, the following lethality rates were observed:
Dose (mg/kg b.w.) | Male animals | Female animals | ||
Absolute | Relative (%) Absolute Relative (%) | |||
2000 | 5/5 | 100 | 5/5 | 100 |
500 | - | - | 3/5 | 60 |
315 | 0/5 | 0 | 1/5 | 20 |
Applicant's summary and conclusion
- Executive summary:
The acute oral toxicity testing of Lauryl-hydroxyethylimidazolinei n the rat yielded the following median lethal dose (LD50): Female animals: 448.9 mg/kg body weight Male animals did not show a higher sensitivity to the test substance. Lethality occurred up to day two of the study. Besides unspecific symptoms the animals showed impairments of motility and respiration as well as drawn in flanks. Additionally, hypoactivity, stupor, bristling coat, narrow palpebral fissures and trembling and were observed. Development of body weight was not impaired. Necropsy of the decedent animals revealed black discolored spleen, stomach filled with gas, diffuse reddening of the stomach mucosa and detachment of the stomach and small intestine mucosa as well as blood in the small intestine, small intestine filled with dark yellow mucous, urine bladder filled with dark red fluid, positive test of blood in urine, abdominal cavity filled with light red fluid. The animals killed at the end of the observation period showed no macroscopically visible changes.
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.
