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Diss Factsheets
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EC number: 687-691-8 | CAS number: 709031-43-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid - liquid: suspension
- Details on test material:
- Batch #2D48725 Lot002
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10%,, 25% and 50% (M/v)
- No. of animals per dose:
- 4
- Details on study design:
- 4 Groups of four female mice were assigned to study in total. The first group were the control group (vehicle control = DMF) and the other 3 groups were assgined for the 3 differenct concentrations of the test article (10%, 25% and 50%)
Eadh group of four female mice was subjected to application of the vehicle or one of the test formulations to the outer aspect of teh auditory pinnae, once daily on Days 1, 2 and 3.
On day 6 the mice were placed under an infra-red heat lamp, to cause dilation of the peripheral blood vascalature and thus facilitate intravenous dosing. EAch mouse was transferred to a cylindrical restrainer. A plastic syringe and fine gauge hypodermic needle were used to administer 0.25 mL of phosphate buffered saline incorporating 20 UCi of tritiated tymidine into a tail vein of each mouse.
After treatment the mice were returned to the group cage
Approx 5 hours after intravenous injected of the tritiated thumidine, all mice were killed by Halothane asphyxiation, Killing was organised to minimse the interval between death and the recovery of the auricular lymph notes to no more than 15 minutes.
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: The theshold level for the Prolifereation Index to be considered a positive indicator of moderate to severe potential to cause skin sensitisation is 3.0. PI = Test Group CLM value/Control Group CLM value
Any other information on results incl. tables
Sample Id |
No of sites yielding lymph nodes | CPM | CPM per node | Proliferation Index (PI) |
Scintillation Fluid (blank) | - | 11.33 | - | - |
Scintillation fluid with5% m/v trichloroacetic acid | - | 189.84 | - | - |
Vehicle control (DMF) | 8 | 1397.82 | 174.73 | - |
BMS 528235 -01, 10% m/v | 8 | 1109.15 | 138.64 | 0.8 |
BMS 528235 -01, 25% m/v | 8 | 824.21 | 103.03 | 0.6 |
BMS 528235 -01, 50% m/v | 8 | 1042.56 | 130.32 | 0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The proliferation index for all three dose levels was less than 3.0, indicating that the test article does not have a strong sensitising potential.
- Executive summary:
The Local Lymph Node Assay demonstrated that BMS 528235 -01 does not have a potential to cause skin sensitisation.
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