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Diss Factsheets
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EC number: 947-036-1 | 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
- Study period:
- 19 October - 12 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (carboxylatomethyl)hexadecyldimethylammonium
- EC Number:
- 211-748-4
- EC Name:
- (carboxylatomethyl)hexadecyldimethylammonium
- Cas Number:
- 693-33-4
- Molecular formula:
- C20H41NO2
- IUPAC Name:
- [hexadecyl(dimethyl)ammonio]acetate
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- Batch No.: UB 4051
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Rive Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg &, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Not specifically mentioned.
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 169-184 g
- Fasting period before study: 16 hours
- Housing: during the 14 day observation period the animals were kept in groups of 3 in MAKROLON cages (type III plus).
- Diet: commercial diet, ssniff R/M-H V1534 ad libitum. Discontinued 16 h before administration.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 12-18
- Photoperiod (hrs dark / hrs light): 12/12 (approx 150 lux when lit)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not stated
- Amount of vehicle (if gavage): not stated
- Justification for choice of vehicle: Test item soluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw per administration
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw based on expected low toxicity of the test item. - Doses:
- 300 or 2000 mg/kg bw, given as two doages of 150 or 1000 mg/kg bw, respectively.
First administration at t = 0 h
Second administration at T = 3 h. - No. of animals per sex per dose:
- 6 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration, then daily during the 14-d period. Body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological changes. - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw - no deaths
2000 mg/kg bw - 4/6 animals died - Body weight:
- All surviving animals gained the expected wieght at the end of the study period.
- Gross pathology:
- No pathological changes observed at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of this study, the LD50 is >300 <2000 mg/kg bw.
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