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EC number: 805-580-6 | CAS number: 1431696-36-4
- 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:
- 03 May 2012 to 31 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- benzyltrimethylazanium 2-hydroxy-2-methylpropanoate
- EC Number:
- 805-580-6
- Cas Number:
- 1431696-36-4
- Molecular formula:
- C14 H23 O3 N
- IUPAC Name:
- benzyltrimethylazanium 2-hydroxy-2-methylpropanoate
- Test material form:
- other: solid
- Details on test material:
- - Storage conditions: Room temperature; under N2; dry; protect against humidity
- Physical state/ color: solid/ beige
- Homogeneity: The test item was homogeneous by visual inspection
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 – 11 weeks)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Weight at study initiation: Animals of comparable weight
HOUSING and DIET
- Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
- Air changes per hour: approx. 10
- Day / night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
- Type of cage: Makrolon cage, type III
- Number of animals per cage: Single housing
- Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Drinking water: Tap water ad libitum
- Bedding: H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
- Enrichment: NGM E-022; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg bw: 40 g/100 mL; 300 mg/kg bw: 6 g/100 mL; 50 mg/kg bw: 1 g/100 mL
- Amount of vehicle (if gavage): 5.00 mL/kg bw
- Justification for choice of vehicle: Good homogeneity in olive oil Ph.Eur.
DOSAGE PREPARATION: For better handling the test item was ground with a pestle and mortar. The test item preparation was produced for
each application group shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer.
CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. As all animals died, 300 mg/kg bw were administered to 3 female rats in the second step. After administration all animals died in the second step. Therefore 50 mg/kg were given to a further group of three fasted females in the third step. Because no mortality occurred, 50 mg/kg bw were administered to another group of 3 female animals in the fourth step. - Doses:
- 2000, 300, 50 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg bw: 3 females
300 mg/kg bw: 3 females
50 mg/kg bw: 6 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time. Necropsy of all animals that died before as early as possible after death.
- Clinical signs: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Mortality: A check for any dead or moribund animals was made at least once each workday, these records are archived by Bioassay.
- Histology: No histological examinations were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred at 50 mg/kg bw. No animal survived dosing with 300 mg/kg bw.
- Mortality:
- All animals died in the 2000 mg/kg bw and 300 mg/kg bw test groups within 1 hour after application.
No mortality occurred in the 50 mg/kg bw test groups - Clinical signs:
- other: All animals of the 2000 mg/kg bw test group and 2 animals of the 300 mg/kg bw died immediately after administration. Therefore no clinical signs could be determined. One animal of the 300 mg/kg bw test group showed poor general state, dyspnoea, piloerecti
- Gross pathology:
- The three animals that died in the 2000 mg/kg bw test group showed liquid content in the stomach and black discoloration of liver. In two animals of the 300 mg/kg bw test group dark red spotted discoloration of the lung was noted at necropsy. One animal of this test group didn’t show any findings. In the 50 mg/kg bw test group no macroscopic pathological findings were noted in the animals sacrificed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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