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Diss Factsheets
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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The method is approved by international regulatory agencies as a replacement for the identification of corrosives in the in vivo Rabbit skin assay (OECD 404) and is specifically approved as a replacement for the in vivo skin corrosivity test within OECD 431.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- EPISKIN model
- GLP compliance:
- yes (incl. QA statement)
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
Cas no.: 111304-31-5
Batch no.: ND-78
Date of analysis: October 2014
Re-test date: October 2015
Storage: In well closed vial up to 25 °C
Description: white crystalline substance
Purity: 99,6%
Constituent 1
Test system
- Details on study design:
- EpiSkin Small Model (EpiSkin SM) is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazansalt that is quantitatively measured after extraction from tissues (Faller C. et al., 2002, Mosmann T., 1983) The reduction of cell viability in treated tissues is compared to negative controls and expressed as a %. The % reduction in viability is used to predict the irritation potential.
The negative control is Phosphate Buffered Saline, the positive control is Sodium Dodecyl Sulphate.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: mean tissue viability %
- Basis:
- mean
- Time point:
- other: Cell viability measurements on day 2
- Score:
- 93
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test item Niliden did not show significantly reduced cell viability in comparison to the negative control (mean value: 93%)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained from this in vitro skin irritation test, using the EpiSkin model indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item Niliden is considered to be non irritant to skin and is therefore not classified (EU Non Irritant; UN GHS No category)
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