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EC number: 248-363-6 | CAS number: 27247-96-7
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5 February 1998 to 27 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was completed in 1998 prior to widespread regulatory acceptance of LLNA
Test material
- Reference substance name:
- 2-ethylhexyl nitrate
- EC Number:
- 248-363-6
- EC Name:
- 2-ethylhexyl nitrate
- Cas Number:
- 27247-96-7
- Molecular formula:
- C8H17NO3
- IUPAC Name:
- 2-ethylhexyl nitrate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: breeder Charles River (France)
- Age at study initiation: approximately 3 months old
- Weight at study initiation: mean body weight +/- standard deviation of 329 g +/- 17 g for males and 342 g +/- 11 g for females
- Housing: polycarbonate cages
- Diet (e.g. ad libitum): 106 pelleted diet
- Water (e.g. ad libitum): drinking water filtered by a F.G Muillipore membrane (0.22 microns)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From 10 February 1998 to 13 March 1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Test item administered undiluted.
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Test item administered undiluted.
- No. of animals per dose:
- 10 males and 10 females for treated group, 5 males and 5 females for control group
- Details on study design:
- RANGE FINDING TESTS:
Yes, to determine the concentrations to be used:
- the maximal practicable concentration or concentration causing weak to moderate skin reactions for induction
- the highest concentration which does not cause irritant effect.
The test item was used undiluted during the inductions and challenge phases.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours for each application
- Test groups: treated with the test substance (0.5 mL)
- Control group: treated with purified water (0.5 mL)
- Site: anterior flank
- Frequency of applications: days 1, 8 and 15
- Concentrations: substance used undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: 6 hours
- Test groups: treated with the test substance (0.5 mL) on the right flank and with purified water (0.5 mL) on the left flank
- Control group: treated with the test substance (0.5 mL) on the right flank and with purified water (0.5 mL) on the left flank
- Site: posterior right and left flank
- Concentrations: substance used undiluted
- Evaluation (hr after challenge):
OTHER: - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro chlorobenzene (DNCB)
Results and discussion
- Positive control results:
- 33% of the animals (3/10) showed a positive reaction with the DNCB.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs and no death were noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs and no death were noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs and no death were noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs and no death were noted.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5% w/w
- No. with + reactions:
- 6
- Total no. in group:
- 9
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5% w/w
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- Dryness of skin in 3 animals
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions of the study and according to the Buehler method, the test substance 2-ETHYLHEXYLE NITRATE does not induce delayed contact hypersensitivity in guinea-pigs.
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