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EC number: 279-976-7 | CAS number: 82486-82-6
- 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:
- October 12, 1991 - October 30, 1991.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- not mentioned in report
Test material
- Reference substance name:
- 2-(butylnitroamino)ethyl nitrate
- EC Number:
- 279-976-7
- EC Name:
- 2-(butylnitroamino)ethyl nitrate
- Cas Number:
- 82486-82-6
- Molecular formula:
- C6H13N3O5
- IUPAC Name:
- butyl(nitro)[2-(nitrooxy)ethyl]amine
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BuckberG Lab Animals, Tomkins Cove, New York
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 300-700 grams
- Housing: Separate isolation by test system Light cycle - 12 hours light, 12 hours dark Temperature/Relative Humidity - Every attempt
was made to maintain a temperature of 22°C ± 3°C (66-77°F) and a relative humidity of 30 to 70%.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 300mg
- Day(s)/duration:
- 30
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 300mg
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 for test item, 5 for positive control, 10 for negative control
- Details on study design:
- RANGE FINDING TESTS: Prior to initiation of the studies, the irritation potential of each test article was determined in a dose-range-finding study. Four (4) previously unexposed animals were each exposed to four concentrations of 1.0, 10 and 50% of the test article in acetone and as received, by the technique described in site preparation. The procedure for primary challenge was used in grading the responses except that only 24 hour grades were obtained. No signs of erythema were observed at any treatment site with the exception of slightly patchy erythema in one animal treated with EtNENA as received. Therefore, the decision was made to dose the test articles in the definitive studies as received.
MAIN STUDY
All materials were applied beneath a 25 mm Hill Top Chamber1*, (Hill Top Research, Inc., Miamiville, Ohio) and covered with dental dam. The patch and dam were held in place with clips attached to the sides of the guinea pig restrainer. The patches were allowed to remain in place for six hours, after which the rubber dams and patches were removed. This procedure was performed once per week for three weeks, a total of three six hour inductions. The treated sites were examined after each dosing day and scored at 24 and 48 hours for erythema.
CHALLENGE EXPOSURE
Fourteen days after the last induction exposure, all animals were challenged in the same manner on a naive site on the left flank. The negative control animals were challenged with distilled water or 80% ethanol on the left flank and test article on the right flank. Twenty-four hours after challenge, all animals
were depilated with NeetR Hair Remover (Whitehall Laboratories, Inc., New York 10017). The depilatory was applied to the test sites and surrounding areas and removed within 30 minutes by thoroughly rinsing with water and gently patting dry. They were then returned to their cages. A minimum of two hours after depilation, test sites were graded for erythema. The scoring was repeated twenty-four hours later (48 hour grade). - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- A positive response was elicited in the animals treated with the positive control article.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 300 mg/site
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 300 mg/site
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Group:
- negative control
- Dose level:
- 100mg/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: The negative control animals were challenged with distilled water or 80% ethanol
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: DCNB in 80% ethanol
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the Delayed Contact Hypersensitivity Study in Guinea Pigs (Buehler Assay), test articles MeNENA, EtNENA, BUNENA, BDNPA/F+DPA and BDNPA/F-DPA did not cause dermal sensitization in guinea pigs under
the conditions of this study. Dermal sensitization was elicited in the animals receiving the positive control article, 1- chloro-2,4-dinitrobenzene at a 0.3% concentration.
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