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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 April 2012 to 02 May 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:
- other: OECD TG No. 437, September 07, 2009 “Bovine Corneal Opacity and Permeability Test, Method for Identifying Ocular Corrosives and Severe Irritants"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) No. 1152/2010 of 8 December 2010 Part B: Bovine Corneal Opacity and Permeability Test, Method for identifying ocular corrosives and severe irritants; Official Journal of the European Union, No. L324
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- - Purity: The test substance has been characterized analytically.
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- pH-value: Ca. 7 (undiluted test substance, moistened with water). Ca. 5 (20% aqueous preparation)
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- other: isolated bovine cornea
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The test system (target tissue) is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months). Supplier: Schlachthof Bensheim, Am Schlachthof 7-9, 64625 Bensheim, Germany
Test system
- Vehicle:
- other: de-ionized water
- Amount / concentration applied:
- 20% (w/v) solution in de-ionized water
- Duration of treatment / exposure:
- 4h
- Observation period (in vivo):
- Not applicable.
- Number of animals or in vitro replicates:
- 3 corneas per treatment group
- Details on study design:
- - Preparation of the bovine corneas and measurement of initial corneal opacity: Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in specially designed corneal holders that consists of anterior and posterior chambers. Both chambers were filled to excess with prewarmed Eagles’s MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour.
After the equilibration period the medium in both chambers was replaced with fresh prewarmed
medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that show macroscopic tissue damage or an opacity value < 507 opacity units1 were discarded. Corneas with opacity values close to the median value of all corneas were selected as negative control (NC). The remaining corneas were then distributed into treatment and positive control groups. Each corneal holder was uniquely identified with a number on the chambers.
- Application of the test substance and washing: Each treatment group (test substance, NC and PC) consisted of 3 corneas. Before application the medium in the anterior chamber was removed using a syringe. 750 μL of the 20% (w/v) test-substance preparation (non-surfactant) was applied into the
anterior chamber using a pipette. Control tissues were concurrently applied into the anterior chamber with 750 μL of de-ionized water (negative control, NC) or with 750 μL of 20% (w/v) solution of Imidazole in de-ionized water (positive control, PC) using a pipette. The corneas were incubated in a horizontal position at about 32 °C for approximately 4 hours (non-surfactant solids). The test substance, NC and PC were then removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red).
- Measurement of final corneal opacity: Before measurement, each cornea was observed visually and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Determination of permeability: For determination of permeability the medium in the anterior chamber was replaced by 1 mL sodium fluorescein solution (5 mg/mL for solid test substances) and incubated for 90 ± 5 min in a horizontal position at about 32 °C. The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was measured spectrophotometrically. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Opacity score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 28
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: Permeability score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.006
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 28
- Reversibility:
- other: not applicable
- Remarks on result:
- other: A score of 55 or higher indicates highly irritatig properties.
- Irritant / corrosive response data:
- Based on the observed results and applying the evaluation criteria it was concluded, that the substance does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.
Applicant's summary and conclusion
- Interpretation of results:
- other: not highly irritating
- Remarks:
- Criteria used for interpretation of results: EU
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