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EC number: 810-021-4 | CAS number: 111304-31-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study had been performed in accordance with OECD Guideline No.:429.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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 substance name:
- methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate
- EC Number:
- 810-021-4
- Cas Number:
- 111304-31-5
- Molecular formula:
- C12H11NO5
- IUPAC Name:
- methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate
- Test material form:
- solid: crystalline
- Details on test material:
- Name: Niliden (Nifedipine Intermediate 11)
CAS: 111304-31-5
Batch No.: ND-78
Description: A white to pale yellow crystalline substance
Date of analysis: 10 2014
Storage: in well closed vial, up to 25 °C
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Number of animals: 24 animals / main test (4 animals/treatment group)
Sex: Female, nulliparous, non-pregnant
Age of animals: 8-9 weeks old (at start of the main test)
Body weight range at starting: 17,2 - 22,0 g
Acclimatization time: 7 days
Light: 12 hours daily, from 6:00 a.m. to 6:00 p.m.
Temperature: 22± 3 °C
Relative humidity: 30-70 %
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25 %
- No. of animals per dose:
- Dose range finding animals: 4 female animals
Main test animals: 24 female animals - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control group animals were treated with 25 % (w/v) HCA solution (dissolved in AOO) concurrent to the test item treated groups. No mortality, cutaneous reactions or sign of toxicity were observed in the positive control group. Significant lymphoproliferative response (SI≥3) was noted for HCA (SI=7.3) The results of the positive control item demonstrated appropriate performance of the test in accordance with the relevant guidelines and confirmed validity of the assay.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: The observed stimulation index values were 14.4, 13.5 or 12.2 at concentrations of 10 %, 5 %, and 2.5 % (w/v), respectively.
Any other information on results incl. tables
The maximum dose selection was performed according to the relevant guidelines and based on results of a formulation evaluation and also results of the preliminary irritation/toxicity test. Since the test was valid and no signs systemic toxicity or significant irritation were observed the proliferation values obtained are considered to reflect the real potential of the test item to cause lymphoproliferation in the Local Lymph Node Assay.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present assay, niliden tested at the maximum feasible (non-toxic, non-irritant) concentration of 10 % and at concentrations of 5 % and 2.5 % (w/v) as formulations in a suitable vehicle (DMF) was shown to have skin sensitization potential (skin-sensitizer) in the Local Lymph Node Assay (LLNA).
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