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Diss Factsheets
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EC number: 951-515-0 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Oct 2017 to 05 Dec 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The MalTek EpiDerm™ MTT Viability Assay has been demonstrated to be a quantitative method for assessing potential skin hazards.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Co-crystal of 4-bromo-2-isopropylphenol and 1,4-diazabicyclo[2.2.2]octane (2:1)
- EC Number:
- 951-515-0
- Molecular formula:
- (C9H11BrO)2.C6H12N2
- IUPAC Name:
- Co-crystal of 4-bromo-2-isopropylphenol and 1,4-diazabicyclo[2.2.2]octane (2:1)
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: not specified
- Cell source:
- other: not specified
- Source strain:
- not specified
- Justification for test system used:
- The MatTek EpiDerm™ MTT Viability Assay has been demonstrated to be a quantitative method for assessing potential skin hazards.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm™ Tissue Samples
EpiDerm™ tissues, Lot 27154 Kit R, were received from MatTek on 10 Oct 2017 and refrigerated at 2-8ºC. Before use, the tissues were incubated (37oC ± 1oC, 5% ± 1% CO2) with assay medium (MatTek) for a one-hour equilibration. Equilibration medium was replaced with fresh medium before dosing. - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- 100mg
- Duration of treatment / exposure:
- For 0.5, 4, and 24 hours.
- Number of replicates:
- 3 different doses, but no replicates per dose
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 0.5 hours
- Value:
- 43.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1.0 hours
- Value:
- 39.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4.0 hours
- Value:
- 31.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ET50 score of <0.5 hours
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test articles provided by Merck & Co., Inc. were tested using the MatTek EpiDerm™ MTT Viability Assay. At the request of the Sponsor, the test articles were dosed neat. The ET50 scores were converted to an irritancy classification. The ET50 score of the positive control, 1% Triton® X-100, was 6.0 hours, which met MatTek's acceptance criterion of 4.8-8.7 hours.
The summarized data and irritation classifications are as follows:
Test and Control Article Identity ET50 (hr) Irritancy Classification
L-006266209-000K003 <0.5 Severe, Probable Corrosive
1% Triton® X-100 (Positive Control) 6.0 Within Range (4.8 - 8.7)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.