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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-073-0 | CAS number: 5261-99-4
- 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 27 November 2012 to 04 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
- EC Number:
- 226-073-0
- EC Name:
- [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
- Cas Number:
- 5261-99-4
- Molecular formula:
- C7H17N2O2.Cl
- IUPAC Name:
- 4-amino-2-hydroxy-N,N,N-trimethyl-4-oxobutan-1-aminium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Analytical purity: 99,4%
- Lot/batch No.: WI 2274
- Storage condition of test material: at room temperature not exceeding 40°C.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germany
- Age at study initiation: 9-10 week old
- Weight at study initiation: 193-205 g
- Fasting period before study: On the day before the start of the experiment, i.e. about 19 hours before the administration of the test item, the food was withheld but the water was still available.
- Housing: The animals were kept in plastic cages covered with wire bar lids. The dimensions of the cages were as follows: 58 x 37 x 21 cm (length x width x height). In the sighting study, the animal was caged individually, whereas in the main study, there were four animals per cage.
- Diet (e.g. ad libitum): “Murigran” standard granulated laboratory fodder, ad libitum
- Water (e.g. ad libitum): drinking tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 22 °C
- Humidity (%): 38 – 70%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark
IN-LIFE DATES: From: 30 November 2012 To: 14 December 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.5 mL/100 g of animal body weight
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The evaluation of general condition of the animals, i.e. the observation of all animals for morbidity and mortality was conducted twice a day or once a day (on days off) during the 14-day period of the experiment. The detailed clinical observations were performed on the day of the test item administration (day 0), i.e. 10, 30 and 60 minutes after the administration and then at hourly intervals up to 5 hours. From the 1st to the 14th day of the observation period, the detailed clinical observations were made once a day. The animals’ body weight was determined individually directly before the administration of the test item (day 0) and then on the 7th and 14th day.
- Necropsy of survivors performed: yes
After the 14-day observation period, all animals which survived the experiment were killed by an intraperitoneal administration of morbital at a dose of 200 mg/kg b.w. and subjected to the post mortem examination.
Results and discussion
- Preliminary study:
- Following a single administration of the test item at a dose of 2000 mg/kg b.w. to one animal used in the sighting study, some signs of toxicity were visible on the administration day. These included a slight decrease in locomotor activity, dejection and a bristled coat – from the 1st to the 5th hour after the administration. On 1st and 2nd day after the administration, the animal’s gait was wavering. The animal survived the 14-day observation period. During the entire experiment, the animal’s body weight increased. The animal necropsy did not reveal any pathological changes.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Following a single administration of the test item at a dose of 2000 mg/kg b.w. to four animals used in the main study, no clinical signs were observed in these animals. All animals survived the 14-day observation period.
- Gross pathology:
- The animal necropsy did not reveal any pathological changes.
Any other information on results incl. tables
Table 1: Summary of acute oral toxicity
Females |
|
Dose |
Mortality |
2000 mg/kg bw |
0/5 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 for the test substance was greater than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity study – fixed dose procedure, according to the OECD Guideline No. 420 / EU Method B.1.bis, was performed in order to obtain information on health hazards likely to arise from a single oral exposure caused by the consumption of the test item. The experiment commenced with a sighting study in which the test item at a single dose of 2000 mg/kg b.w was administered to one animal. On the grounds of the sighting study results, four animals used in the main study were given the test item at a dose of 2000 mg/kg b.w. (the animal of the sighting study was included in the main study). After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted daily during the entire experiment. The animals’ body weight was determined individually on day 0 (directly before the administration of the test item) as well as on the 7th and 14th day.
After the 14-day observation period, all animals which survived the experiment were euthanized and subjected to a necropsy and a detailed gross examination. Following a single administration of the test item at a dose of 2000 mg/kg b.w. to one animal, some signs of toxicity were observed. The animal survived the 14-day observation period. Following a single administration of the test item at a dose of 2000 mg/kg b.w. to the next four animals used in the main study, no clinical signs were observed during the 14-day observation period. All animals survived the observation period. Body weight gains were stated in all animals. The animal necropsy did not reveal any pathological changes. The oral LD50 for the test substance was greater than 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.