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Diss Factsheets
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EC number: 947-596-7 | CAS number: -
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Structure similarity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- EC Number:
- 219-730-8
- EC Name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- Cas Number:
- 2512-29-0
- Molecular formula:
- C17H16N4O4
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0%, 2%, 4%, 8% (w/v)
- No. of animals per dose:
- 5 females per dose group2 females in the pre-test
- Details on study design:
- RANGE FINDING TESTS: - non GLP- Compound solubility: 8% (w/v) suspension in DMSO was the highest technically applicable concentration; higher concentrations could also not be achieved with other vehicles- Irritation: no swelling was observed at concentrations of 1.0, 2.0, 4.0 and 8.0% (w/v) after a single application- Systemic toxicity: not observed up to the highest concentration tested- Lymph node proliferation response: not examinedMAIN STUDYANIMAL ASSIGNMENT AND TREATMENT- Name of test method: LLNA- Criteria used to consider a positive response:1: exposure to at least one concentration of the test item resulted in an incorporation of 3H-methyl thymidine at least 3-fold or greater than that recorded in control mice as indicated by the stimulation index2: data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppressionTREATMENT PREPARATION AND ADMINISTRATION:- individual preparation of weight volume dilutions using a magnetic stirrer as homogenizer- test item preparations were made freshly before each dosing occasion- 25 µl were spread over the entire dorsal surface of each ear lobe once daily for three consecutive days
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - calculation of mean values and standard deviations for body weight- Dunnett-test (ANOVA) to test for statistical significance of the results between the test item groups
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- > 1 - < 1.4
- Remarks on result:
- other: Stimulation indices were all below 3. The following SI were calculated: 2% test item: 1.3 4% test item: 1.2 8% test item: 1.4
Any other information on results incl. tables
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. The body weight of the animals was within the normal range. Calculation of the EC3 value was not performed, because no test concentration produced a SI of 3 or higher.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not sensitising in this LLNA in concentrations up to 8% (w/v) in DMSO, the highest technically achievable concentration.
- Executive summary:
The test item was assessed for its possible contact allergenic potential in a local lymph node assay according to OECD TG 429. The test was performed using test item concentrations of 2, 4 and 8% (w/v). The animals (5 female mice/dose group) did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 1.3, 1.2 and 1.4 were determined with the test item at concentrations of 2, 4 and 8% (w/v) in DMSO, respectively. The results obtained with the positive control confirmed the validity of the test. The test item was not a skin sensitiser under the conditions tested.
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