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EC number: 807-342-7 | CAS number: 1009119-83-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 21, 2014 to July 10, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is acceptable as it followed OECD methods and was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(2S)-pyrrolidin-2-yl]-5-(4'-{2-[(2S)-pyrrolidin-2-yl]-1H-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1H-imidazole tetrahydrochloride
- EC Number:
- 807-342-7
- Cas Number:
- 1009119-83-8
- Molecular formula:
- C26H32Cl4N6
- IUPAC Name:
- 2-[(2S)-pyrrolidin-2-yl]-5-(4'-{2-[(2S)-pyrrolidin-2-yl]-1H-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1H-imidazole tetrahydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Off-white powder stored at room temperature and protected from expsure to light.
Constituent 1
Test system
- Amount / concentration applied:
- Since the test article was a solid (powder), four samples of 500±5 mg were preweighed.
The test article was administered by direct addition to each of the four membrane discs. Due to
the low density of the test article, the pre-weighed samples had large volumes, and only
approximately half of each 500±5 mg sample was able to be applied to the membrane discs. - Details on study design:
- The experimental design of this study consisted of a qualification screen with the Chemical Detection System (CDS), a pH determination, a categorization screen, and a definitive Corrositex® assay in the CDS. The Corrositex® assay was evaluated on the basis of a color change in the CDS. The number of minutes elapsed before a color change was observed (if any) was recorded manually and these break through times for the four replicates were used to determine the Packing Group. If a test article break through did not occur, the test article was considered non-corrosive.
A scintillation vial containing the biobarrier matrix powder was placed in a water bath on a stirring hot plate. The entire contents of the biobarrier
diluent vial were added slowly to the matrix powder. The solution was warmed to 64-68ºC to solubilize the biobarrier matrix. Using a repeat pipettor 200 µL of the solubilized matrix solution were pipetted into each membrane disc. The membrane discs were then stored at 2-8ºC in a refrigerator overnight before being used for corrosivity testing.
The positive control used in this study was sodium hydroxide (NaOH) (Sigma, CAS # 1310-73-2, >97% ACS). The negative control used in this study is 10% Citric Acid. A blank vial of CDS was used as a color comparison control. Each assay included a blank (color) control, a negative control and a positive control (tested in a single membrane disc).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: corrosive packing group III
- Value:
- ca. 50
- Remarks on result:
- other:
- Remarks:
- Basis: mean Break through time (min:sec). Remarks: pH is 1.5. (migrated information)
In vivo
- Irritant / corrosive response data:
- Positive control (NaOH) had a mean break through time of 13:56. The results of the positive control, NaOH (Sigma, CAS # 1310-73-2, >97% ACS), fell within two standard deviations of the historical mean (acceptance range: 8:13 to 15:02 min:sec), thereby meeting the acceptance criteria.
- Other effects:
- A deviation from the protocol occurred during conduct of the assay. On 23 May 2014,
samples of approximately 500 ± 5 mg of the test material were pre-weighed into glass vials;
however, due to the large volume of the test material, each sample was unable to be fully applied
onto the biobarrier membrane discs. Approximately half of the pre-weighed samples were
applied to each membrane disc. Since the results of the assay gave a corrosive classification, it
was demonstrated that an interaction of the test article with the biobarrier was achieved with the
reduced volume. Therefore, this deviation did not have a significant effect on the assay results.
Any other information on results incl. tables
Qualification and pH Screen:
For the qualification screen, 100±1 mg of the test article were added to the CDS
qualification tube. The test article produced an immediate color change in the CDS, and was
therefore qualified for testing in the Corrositex® assay.
Next, 100±1 mg of the test article were added to 1 mL of sterile, deionized water. The
test article dilution was exposed to pH paper (EMD Millipore Corporation) with a 0-14 pH range
in 1 pH unit increments to approximate a narrow pH range. Next, the test article dilution was
exposed to pH paper with a narrower range of 0-6 pH units in 0.5 pH unit increments, to obtain a
more accurate pH value. The pH value obtained from the narrower range pH paper is presented
in Table 3.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the mean breakthrough time of 50 minutes and 9 seconds, the test article was assigned a corrosive packing group III classification.
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