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EC number: 700-303-4 | CAS number: 84163-13-3
- 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:
- From 2003-05-19 to 2003-06-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted following SPL Standard Test method 595.12.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- SPL Standard Test Method 595.12:
The test is designed to assess the skin sensitising potential (delayed type hypersensitivity) of the test material following topical application to the dorsal surface of the ear. Primary lymphocyte proliferation is assessed during the sensitising (induction) phase of the response. - GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 6-fluoro-3-(piperidin-4-yl)-1,2-benzoxazole hydrochloride
- Cas Number:
- 84163-13-3
- Molecular formula:
- C12H13FN2O.HCl
- IUPAC Name:
- 6-fluoro-3-(piperidin-4-yl)-1,2-benzoxazole hydrochloride
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: 2003-05-19 to 2003-06-16
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25µL per ear at concentration 0, 2.5, 5, and 10% w/w
- No. of animals per dose:
- 4
- Details on study design:
- The assay determines the level of lymphocyte proliferation in lymph nodes draining the application site of the test material. Determination of lymphocyte proliferation is quantified by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells.
RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: Following preliminary sighting tests at which there were no deaths or signs of systemic toxicity at concentrations of 5% and 10%
- Lymph node proliferation response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Stimulation Index greater than 3.
TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of four animals, were treated with 50 µl of the test material (25 µl per ear) as a suspension in dimethyl formamide at concentrations of 2.5%, 5% and 10% w/w. A further group of four animals was treated with dimethyl formamide alone. - Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.46
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.35
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.36
- Test group / Remarks:
- 10%
Any other information on results incl. tables
The Stimulation Index (SI) is expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material (RT 001492) was considered to be a non-sensitiser under the conditions of the test. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Applying the criteria laid down in Regulation (EC) No 1272/2008 the test material (RT 001492) does not require classification as a skin sensitiser (Stimulation index <3).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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