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EC number: 226-373-1 | CAS number: 5382-16-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from handbook or collection of data
Data source
Reference
- Reference Type:
- other: Authorative Database
- Title:
- oral toxicity in mouse for CAS no: 75-75-2
- Author:
- HSDB
- Year:
- 2 017
- Bibliographic source:
- U.S. National Library of Medicine, National Institutes of Health, Health & Human Services, 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The dermal sensitization potential of Dibutylamine (CAS no: 111-92-2) was evaluated in 10 CF1(BR) mice by using Mouse Ear Swelling Test (Sensitization Assay).
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 1-Butanamine, N-butyl-
- Cas Number:
- 111-92-2
- Molecular formula:
- C8H19N
- IUPAC Name:
- 1-Butanamine, N-butyl-
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Di-n-Butylamine
- Molecular formula: C8H19N
- Molecular weight: 129.245 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: N(CCCC)CCCC
-InChI: 1S/C8H19N/c1-3-5-7-9-8-6-4-2/h9H,3-8H2,1-2H3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Di-n-Butylamine
- Molecular formula: C8H19N
- Molecular weight: 129.245 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: N(CCCC)CCCC
-InChI: 1S/C8H19N/c1-3-5-7-9-8-6-4-2/h9H,3-8H2,1-2H3
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CF1(BR)
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: epicutaneous
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 0.1% (0.1mL)
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 48-hour
- Day(s)/duration:
- 0.25% (0.01mL)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 48-hour
- Test groups: 10
- Control group:10
- Site: clipped abdomens
- Frequency of applications: daily for 3 days
- Duration: 3 days
- Concentrations: 0.1% (0.1mL)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 days
- Exposure period: 48-hour
- Test groups: 10
- Control group: 10
- Site: to both dorsal and ventral surfaces of the left ears
- Concentrations: 0.25% (0.01mL)
- Evaluation (hr after challenge): after 48 hours
C.RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 days
- Exposure period: 48-hour
- Test groups: 10
- Control group: 10
- Site: to both dorsal and ventral surfaces of the left ears
- Concentrations: 0.25% (0.01mL)
- Evaluation (hr after challenge): after 48 hours - Challenge controls:
- During challenge, 0.01 ml dermal applications of a 25% (v/v) solution to both dorsal and ventral surfaces of the right ears served as control.
- Positive control substance(s):
- yes
- Remarks:
- A group of 10 mice likewise inducted over 3 days with 0.1 ml dermal applications of 0.5% (w/v) DNCB served as the positive control
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.25% (0.01mL)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None of either test or irritation control groups had responded to challenge.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- One animal challenged with di-n-butylamine exhibited a positive sensitization response (20% increase in ear thickness over control) at 48-hour evaluation only. None of either test or irritation control groups had responded to challenge by the 24-hour evaluation and none responded to rechallenge.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- None of either test or irritation control groups had responded to challenge by the 24-hour evaluation and none responded to rechallenge. Hence the chemical Dibutylamine (CAS no: 111-92-2) was considered as not skin sensitizing in Mouse Ear Swelling Test (Sensitization Assay).
- Executive summary:
The dermal sensitization potential of Dibutylamine (CAS no: 111-92-2) was evaluated in 10 CF1(BR) mice by using Mouse Ear Swelling Test (Sensitization Assay).
Each mice was induced topically daily for 3 days at 0.1 ml of a 0.1% (v/v in ethanol) test solution to clipped abdomens. A group of 10 mice likewise inducted over 3 days with 0.1 ml dermal applications of 0.5% (w/v) DNCB served as the positive control. inducted over 3 days with 0.1 ml dermal applications of 0.5% (w/v) DNCB served as
Challenge and rechallenge were administered 7 and 14 days later in 0.01 ml dermal applications of a 25% (v/v) solution to both dorsal and ventral surfaces of the left and right ears respectively of inducted test mice. The thickness of treated left ears relative to that of solvent control (ethanol) right ears indicated the degree of sensitization. One animal challenged with di-n-butylamine exhibited a positive sensitization response (20% increase in ear thickness over control) at 48-hour evaluation only.
None of either test or irritation control groups had responded to challenge by the 24-hour evaluation and none responded to rechallenge. Conversely, 60% and 50% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.
Hence the chemical Dibutylamine (CAS no: 111-92-2) was considered as not skin sensitizing in Mouse Ear Swelling Test (Sensitization Assay).
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