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EC number: 604-714-9 | CAS number: 149968-48-9
- 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:
- From 2 December 2008 to 9 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study without any restriction
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Erucamidopropyl dimethylamine
- IUPAC Name:
- Erucamidopropyl dimethylamine
- Reference substance name:
- 13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-
- EC Number:
- 604-714-9
- Cas Number:
- 149968-48-9
- Molecular formula:
- not applicable (a generic molecular formula cannot be provided for this UVCB substance)
- IUPAC Name:
- 13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-
- Test material form:
- other: solid lightbeige
- Details on test material:
- - Stability under test conditions: stable in sesame oil for 2-5 hours
- Storage condition of test material: at room temperature, light protected
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd. Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: 178.2 - 192.4 g
- Fasting period before study: overnight (18 to 18.5 hrs) prior dosing and 3 hours post-dosing
- Housing: in group of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 44/08 ad libitum
- Water (e.g. ad libitum): community tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/6 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: from 2 to 25 December 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle:The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Since the test item was not well soluble in water, a second trial was performed with sesame oil, where the test item was well soluble.
- Lot/batch no. (if required): batch N° 067K0069 Sigma Aldrich Chemie GmbH, Switzerland
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): The test item was first reduced into a fine powder using a pestle and a mortar. Thereafter, the pulverized test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume).
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 groups of animals: 3 females/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were checked for viability and clinical signs during the first 30 min and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Mortality was then checked twice daily and animals were observed for clinical signs daily during days 2-15. Animals were weighed on days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes (macroscopic observations, no organs or tissues were retained) - Statistics:
- no statistical analysis was used
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: One hour after dosing, a slightly ruffled fur was noted in three out of six treated females and persisted up to the 5-hour observation. Otherwise, no clinical signs were observed in any animal at any observation.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Other findings:
- No other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, as the LD50 is higher than 2000 mg/kg bw, ERUCAMIDOPROPYL DIMETHYLAMINE is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.
- Executive summary:
In an acute oral toxicity study, performed according to acute toxicity class method Procedure (OECD Guideline 423; EC test method B1.tris) and in compliance with the GLP, groups of female HanRcc:WIST(SPF) rats were given a single oral dose of Erucamidopropyl dimethylamine (purity > 99%) diluted in sesame oil by gavage at the dose of 2000 mg/kg bw (Limit test). Clinical signs, mortality and body weight gain were checked for a period of up to 14 days. All surviving animals were sacrificed at the end of the study and necropsied for gross abnormalities.
The starting dose was stated as 2000 mg/kg bw and tested in a group of 3 female rats. As no mortality occurred and no severe clinical signs were observed,3 further fasted females were given a single oral dose of 2000 mg/kg bw. No mortality occurred in this second group. One hour after dosing, a slightly ruffled fur was noted in three out of six treated females and persisted up to the 5-hour observation. Otherwise, no clinical signs were observed in any animal at any observation. There was no effect on the bodyweight and no macroscopic findings were recorded at necropsy.
Under these experimental conditions, the LD50 in rat was determined to be higher than 2000 mg/kg bw. Therefore no classification for acute oral toxicity is required forErucamidopropyl dimethylamineneither according to the criteria of the Regulation (EC) 1272/2008 (CLP including ATP3) nor according to the criteria of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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