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EC number: 203-851-8 | CAS number: 111-26-2
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study Please refer to section 13 (read across statement).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Butylamine
- EC Number:
- 203-699-2
- EC Name:
- Butylamine
- Cas Number:
- 109-73-9
- IUPAC Name:
- butan-1-amine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., MD
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 25 - 33 g (m); 24 - 33 (f)
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: 5/cage/sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-3 °C (74 +-6 °F)
- Humidity (%): 50 +-20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water
- Details on exposure:
- Dosage volume: 20 mL/kg bw
- Duration of treatment / exposure:
- 24, 48, and 72 h post-application
- Frequency of treatment:
- 1x
Doses / concentrations
- Remarks:
- Doses / Concentrations:
125, 250, and 500 mg/kg bw
Basis:
other: 6.25, 12.5, and 25 mg/mL, dose volume 20 mL/kg bw
- No. of animals per sex per dose:
- 15 (5 per time interval per sex)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide, 40 mg/kg bw (oral, gavage)
Examinations
- Tissues and cell types examined:
- Bone-marrow from femurs, polychromatic erythrocytes (PE), normocytes (NE)
EXAMINATIONS:
- Clinical observations: after dose administration
- Number of micronucleated polychromatic erythrocytes per 1000 PCE
- The proportion of polychromatic erythrocytes to total erythrocytes - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
prior toxicity testing/range finding
TREATMENT AND SAMPLING TIMES: 1x dosing / 3x sampling 24, 48, and 72 h p.a.
DETAILS OF SLIDE PREPARATION: air-drying, fixing in methanol, staining with May-Grünwald-Giemsa cocktail
METHOD OF ANALYSIS: Light microscopy - Evaluation criteria:
- Validity:
The mean incidence of micronucleated PCE (MPCE) must not exceed 5/1000 PCE (0.5 %) in the negative (vehicle) control.
The incidence of micronucleated PCE (MPCE) in the positive control must be significantly increased relative to the neg. control (p =<0.05).
Determinations in test groups:
Incidence of MPCE; proportion of PCE to total erythrocytes (impact on erythropoiesis) in each animal and group:
- positive response when there is a dose-response and one or more doses result in significant increases above neg. control.
- questionable when a single treatment results in a significant increase with no evidence of dose-response.
- negative when no significant increase is seen above the neg. control. - Statistics:
- Kastenbaum-Bowman tables (binominal distribution) for significance of differences from neg. control
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Mortality of males at 72 h
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range for acute toxicity: 50 - 1500 mg/kg bw
- Solubility: miscible
- Clinical signs of toxicity in test animals: lethargy, prostration, mortality
- Result: LD50/3 = approx. 500 mg/kg bw, selected as upper dose level
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no increase
- Ratio of PCE/NCE: Maximum reduction of 44 % in the male animals of 500 mg/kg at 48-h treatment time. All other PCE/NCE ratios were less than 30 % compared to the respective vehicle animals.
- Appropriateness of dose levels and route: Highest dose causing treatment-related mortality,
reduction in the ratio of PCE/total erys =<44% indicating bioavailability at the target tissue.
Any other information on results incl. tables
Summary of the bone-marrow study with n-butylamine in ICR mice (from Report, Table 2)
Dose [mg/kg] |
Sex |
Time [h] |
Animal number |
Ratio PCE/total Erys |
Ratio MPCE/5000 Erys scored |
Water |
m / f |
24 |
5 / 5 |
0.57 / 0.53 |
2 / 0 |
48 |
5 / 5 |
0.52 / 0.49 |
3 / 2 |
||
72 |
5 / 5 |
0.53 / 0.61 |
3 / 4 |
||
125 |
m / f |
24 |
5 / 5 |
0.51 / 0.42 |
1 / 1 |
48 |
5 / 5 |
0.48 / 0.52 |
1 / 4 |
||
72 |
5 / 5 |
0.43 / 0.64 |
5 / 7 |
||
250 |
m / f |
24 |
5 / 5 |
0.52 / 0.51 |
0 / 1 |
48 |
5 / 5 |
0.52 / 0.46 |
3 / 4 |
||
72 |
5 / 5 |
0.47 / 0.62 |
3 / 0 |
||
500 |
m / f |
24 |
5 / 5 |
0.45 / 0.48 |
0 / 0 |
48 |
4/ 5 |
0.29 / 0.35 |
~1 / 3 |
||
72 |
0+ / 5 |
-- / 0.53 |
- / 5 |
||
CP [40] |
m / f |
24 |
5 / 5 |
0.42 / 0.54 |
71 / 92* |
EFFECT ON PCE/NCE RATIO: Maximum reduction of 44 % in the male animals of 500 mg/kg at 48-h treatment time. All other PCE/NCE ratios were less than 30 % compared to the respective vehicle animals. GENOTOXIC EFFECTS: Not clastogenic MPCE FREQUENCY: No statistically significant increase in the number of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes relative to their respective vehicle controls.
Applicant's summary and conclusion
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