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EC number: 929-513-6 | CAS number: 1400584-86-2
- 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:
- October 01 - December 20, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- EC Number:
- 929-513-6
- Cas Number:
- 1400584-86-2
- Molecular formula:
- C9H13N2O3 · Na
- IUPAC Name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- Test material form:
- solid: bulk
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
Study design: in vivo (LLNA)
- Concentration:
- 0, 2.5, 5 and 10%
- No. of animals per dose:
- 5
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 10% in DMSO
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 5% in DMSO
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 2.5% in DMSO
- Parameter:
- SI
- Test group / Remarks:
- vehicle control
- Remarks on result:
- other: Control group: 1773 2.5 % in DMSO: 1665 5 % in DMSO: 1174 10 % in DMSO: 1716
Any other information on results incl. tables
Up to the highest concentration tested of 10%, the test substance did not induce any lymphoproliferative response.
There were no confounding effects of irritation or toxicity, so the proliferation values are considered to reflect the sensitization potential of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be a non-sensitizing substance in the Local Lymph Node Assay at all concentrations tested.
- Executive summary:
Twenty female CBA/J mice were allocated to 4 groups of five animals each:
- three groups received the test substance at a concentration of 2.5, 5 or 10% in vehicle,
- one control group received the vehicle, Dimethyl sulfoxide (DMSO).
The test substance or the vehicle were applied on external surfaces of each ear (25 ul/ear) for three consecutive days (Days 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated thymidine and the obtained values were used to calculate proliferation indices.
No mortality and no clinical signs were observed during the study.
No cutaneous reactions were observed in the vehicle or treated groups.
The proliferation index values of the test substance were 0.9, 0.7 and 1.0 at treatment concentrations of 2.5, 5 and 10%, respectively.
BYI 08330 c-HYDANTOIN Na-Salz was found to be a non-sensitizing substance in the Local Lymph Node Assay at all concentrations tested.
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