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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- 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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germany
- Age at study initiation: 8-week old males; 10-week old females
- Weight at study initiation: males 273-300 g; females 209-241 g
- Housing: The animals were kept in plastic cages with the following dimensions: 58 x 37 x 21 cm (length x width x height). The cages were covered with wire bar lids. After the test item application, the animals were caged individually. After the removal of the test item from the animals’ skin, there were five rats per cage. Each sex was kept separately.
- 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 – 67%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark
IN-LIFE DATES: From: 28 November 2012 To: 12 December 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The area of skin treated with the test item was about 41 cm2 (males) and 31 cm2 (females).
- % coverage: about 10% of the total body skin area.
- Type of wrap if used: The powdered test item was applied to gauze patches. Then, the patches were laid on the prepared skin and covered with PVC foil; an elastic bandage was used to make a circular protecting band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The band and the gauze patches were taken off and the residual test item was removed using water
- Time after start of exposure: After 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- 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 mortality and morbidity was conducted twice a day or once a day (on days off) during the 14-day observation period. The detailed clinical observations were made on the administration day (day 0) at hourly intervals up to 5 hours. From the 1st to the 14th day of the observation period, the detailed clinical observations were performed once a day. The animals’ body weight was determined individually directly before the test item administration (day 0) and then on the 7th and 14th day.
- Necropsy of survivors performed: yes
After the 14-day observation period, all animals were humanely killed by an intraperitoneal administration of morbital at a dose of 200 mg/kg and transferred to the gross examination.
Results and discussion
Effect levels
- Sex:
- male/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 application of the test item, no general clinical signs were stated in the animals. Pathological changes on the skin in the site of the test item application were not observed.
- Gross pathology:
- The gross examination did not reveal any pathological changes in the examined animals.
Any other information on results incl. tables
Table 1: Summary of acute dermal toxicity
Males |
Females |
|
Dose |
Mortality |
Mortality |
2000 mg/kg bw |
0/5 |
0/5 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 for the test substance was greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity study, according to the OECD Guideline No. 402 / EU Method B.3, was performed in order to obtain information on health hazards resulting from the possibility of a single exposure due to skin contact with the test item. The test item at a single dose of 2000 mg/kg b.w. was applied to the shaved dorsal skin of 5 males and 5 females for 24 hours. After the administration of the test item, the animals were observed for 14 days. 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 were humanely killed, dissected and subjected to a detailed gross necropsy. Following a single application of the test item, no general clinical signs were stated in the animals.Pathological changes on the animals’ skin in the site of the test item application. All animals survived the period of the experiment were not observed. During the 14-day period of the experiment, all animals’ body weight increased. The gross examination did not reveal any pathological changes in the examined animals. The dermal LD50 for the test substance was greater than 2000 mg/kg bw.
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