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EC number: 700-890-7 | CAS number: 503614-91-3
- 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:
- 25 September to 11 October, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 712-C-03-197
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- no yet approved EU method in 2003
- GLP compliance:
- yes
- Remarks:
- OECD ENV /MC/CHEM(98)17
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- ethyl 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridine-3-carboxylate
- EC Number:
- 700-890-7
- Cas Number:
- 503614-91-3
- Molecular formula:
- C27 H28 N4 O5
- IUPAC Name:
- ethyl 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridine-3-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- At the start of the study the mice were in the weight range of 19.3 grams to 24.0 grams and were 8 - 12 weeks weeks old prior to dosing on Day1. Animlas were acclimatised for 8 days prior to the study.
They were housed individually in polycarbonae cages with woodflake Free access to drinking water and standard laboratory rodent diet food was allowed. The temperature and relative humidity were set to achieve limits of 21 ± 2°C and 40 - 70% respectively. The lighting was controlled by a time switch to give 12 hours of artificial light in each 24 hour period.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- select appropriate one
- Concentration:
- test material at concentrations of 5%, 10% or 25% w/w
- No. of animals per dose:
- Three groups of five animals each were treated at each concentration group and a further group of five animals were treated as a control group with acetone/olive oil alone.
- Details on study design:
- The mice were treated by daily application of 25 μl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3) by using a micropipette whose tip is used to spread the formulation over the dorsal surface of each ear. On Day 6 all mice were injected with 250 ul of a phophate buffered saline solution containing 3H-methyl thymidine (3HTdR ), 80 µCi/ml to the tail vein. All animals were observed twice daily for signs of ill health. The ears were also examined for signs of ittitation. Body weights of each mouse were recorded before dosing and before termination. Five hours after administration of 3HTdR (Day 6 ) all mice were killed by carbon dioxide asphyxiation and their draining auricular lymph nodes were excised. 1 ml of phosphate buffered saline was added to each set of lymph nodes. Preparation of a single cell suspension was completed for the lymph nodes cells for each individual animal following standard procedures. Determination of the 3HTdR incorporation was completed by measuring radioactive disintegration for each animal's lymph node cells by using a beta-scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Analysis of variance (ANOVA) was carried out on the data followed by Barlett's test for analysis of homogenicity of variance.
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde, was considered to be a sensitiser under the conditions of the test with test control ratio obtained for 25% v/v HCA at 8.4.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 5% w/v
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 10 % w/v
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- 25% w/v
Any other information on results incl. tables
There were no deaths and no signs of ill health or toxicity observed during the study. Greasy fur was noted for all control and test animals and particles on the ears was noted post dose from day 1. These signs had resolved completely by day 5. Bodyweight increases were recorded for all mice over the period of the study. |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test material is not regarded as a potential skin sensitizer.
- Executive summary:
The test/control ratios obtained for 5, 10 and 25% w/v BMS 589154-01 were 1.2, 0.9 and 0.5 respectively. As a test/control ratio 3 or more was not recorded for any of the concentrations tested, BMS 589154 -01 is not considered to have the potential to cause skin sensitization (delayed hypersensitivity).
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