Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 947-965-2 | CAS number: -
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication that meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- (2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
- IUPAC Name:
- (2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld
- Age at study initiation: 4 - 7 weeks old
- Weight at study initiation: male 100 - 125 g, female 90 - 115 g
- Fasting period before study: overnight
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw- Doses:
- 4 dose levels: 4000, 5040, 6350 and 8002 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 15 min, 30 min, 1 hour, 2 hours, 4 hours on day of application, once per day thereafter
weighing on day -1, 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no
Results and discussion
- Preliminary study:
- Range finding study with 3 doses: 1000, 2500, 5000 mg/kg bw,
Result: 50 % mortality at 5000 mg/kg
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 106 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 306 - 5 822
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 553 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Dose 4000 mg/kg bw: mortality 2/10
Dose 5040 mg/kg bw: mortality 5/10
Dose 6350 mg/kg bw. mortality 7/10
Dose 8002 mg/kg bw: mortality 10/10 - Clinical signs:
- other: rough fur, eyes closed, sedation, diarrhoea, ataxia, ventral position, gasping, respiration increased, exophthalmos
- Gross pathology:
- The necropsy 14 days after application showed no substance related morphological visible pathologic organ findings in the survived animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50 > 2000 mg/kg, the test item is not acute toxic following single oral application.
- Executive summary:
In an acute oral toxicity study similar to OECD guideline 401, each 5 male/ 5 female, fasted, 4 -7 weeks old Sprague-Dawley rats were given a single oral dose of the test substance by gavage at doses of 4000, 5040, 6350 and 8002 mg/kg bw and observed for 14 days. Clinical signs and death was observed in all dose groups; mortality was 2/10, 5/10, 7/10 and 10/10 in the doses 4000, 5040, 6350 and 8002 mg/kg bw, respectively. The LD50 was calculated to be 5106 mg/kg bw for the test item and 2553 mg/kg bw for the active ingredient. All surviving animals gained the expected weight at the end of the study period. No pathological changes were observed in these animals at necropsy.
Oral LD50 (rat) > 2000 mg/kg bw
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.