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EC number: 203-462-3 | CAS number: 107-10-8
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Mono-n-butylamine-hydrochloride
- IUPAC Name:
- Mono-n-butylamine-hydrochloride
- Reference substance name:
- Butylamine
- EC Number:
- 203-699-2
- EC Name:
- Butylamine
- Cas Number:
- 109-73-9
- IUPAC Name:
- butan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Mono-n-butylamin-hydrochlorid 63%
- Physical state: Colorless liquid
- Lot/batch No.: LJ 20-92
- Other: Room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, WIGA, Sulzfeld, Germany
- Weight at study initiation: ca. 28 g
- Housing: groups of 5 in Makrolon cages
- Assigned to test groups randomly: yes, under following basis: computer program
- Diet: Standardized pelleted feed (Kliba Haltungsdiaet), ad libitum
- Water: tap water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Duration of treatment / exposure:
- 24 h and 48 h.
- Frequency of treatment:
- single intraperitoneal application
- Post exposure period:
- 24 h and 48 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 200, 400, 800 mg/kg bw in a volume of 10 ml/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide; vincristine
- Route of administration: intraperitoneal
- Doses / concentrations: 20 mg/kg bw of cyclophosphamide or 0.15 mg/kg bw of vincristine
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes from the bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: acute intraperitoneal toxicity pretests
DETAILS OF SLIDE PREPARATION:
The bone marrow was prepared according to the method described by SCHMID, W., Chemical Mutagens, Principles and Methods for their Detection, Volume 4, Plenum Press, New York (1976)
METHOD OF ANALYSIS: microscopic analysis - Evaluation criteria:
- The following parameters were recorded:
-Number of polychromatic erythrocytes
-Number of polychromatic erythrocytes containing micronuclei
-Number of normochromatic erythrocytes
-Number of normochromatic erythrocytes containing micronuclei,
- Ratio of polychromatic to normochromatic erythrocytes
-Number of small micronuclei (d < D/4) and of large micronuclei (d > D/M) (d = diameter of micronucleus, D =cell diameter). - Statistics:
- The statistical evaluation of the data was carried out using the program system MUKERN (BASF AG). A comparison of the dose group with the vehicle control was carried out using the Wilcoxon test for the hypothesis of equal medians.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 800 mg/kg bw: irregular respiration, abdominal position and salivation about 15 minutes after administration. 400 mg/kg bw or 200 mg/kg bw: irregular respiration only were observed.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 800 - 1000 mg/kg bw
- Clinical signs of toxicity in test animals: irregular respiration, abdominal position, salivation and squatting posture and the general state of the animals was poor.
Any other information on results incl. tables
Summary of Micronucleus Test Results:
Dose: mg/kg bw | Total No. PCE´s | NCE´s/PCE´s | Micronuclei in PCE´s (‰) |
Micronuclei in NCE´s (‰) |
|
0 (24 h) | 10000 | 4252 | 1.8 | 1.2 | |
0 (48 h) | 10000 | 4609 | 2.5 | 0.9 | |
200 (24 h) | 10000 | 4966 | 1.2 | 1.2 | |
400 (24 h) | 10000 | 3621 | 1.7 | 2.8 | |
800 (24 h) | 10000 | 4676 | 1.8 | 2.1 | |
800 (48 h) | 10000 | 4792 | 1.1 | 1.3 | |
20 mg/kg bw Cyclophosphamide (24 h) | 5000 | 2109 | 22.6x | 2.8 | |
0.15 mg/kg bw Vincristine (24 h) | 5000 | 4828 | 91.2x | 2.8 |
x: p ≤ 0.01
After the single administration of the highest dose of 800 mg/kg body weight, 1.8 ‰ polychromatic erythrocytes containing micronuclei were found after 24 hours and 1.1 ‰ after 48 hours. In the two lower dose groups rates of micronuclei of about 1.7 ‰ (400 mg/kg group) and 1.2 ‰ (200 mg/kg group) were detected after a sacrifice interval of 24 hours in each case.
With 22.6 ‰ the positive control substance cyclophosphamide for clastogenicity, as expected, led to a clear increase in the number of polychromatic erythrocytes containing exclusively small micronuclei at a dose level of 20 mg/kg body weight. With 91.2 ‰ the positive control vincristine for spindle poison effects also led to a clearly enhanced number of micronuclei containing polychromatic erythrocytes with the expected amount of large micronuclei, i.e. 10.8 ‰.
The number of normochromatic erythrocytes containing micronuclei did not differ to any appreciable extent in the negative control or in the various dose groups at any of the sacrifice intervals. Thus, the test substance Mono-n-butylamin-hydrochlorid 63 % did not lead to any increase in the rate of micronuclei. The number of normochromatic or polychromatic erythrocytes containing small micronuclei (d < D/4) or large micronuclei (d > D/4) did not deviate from the solvent control value at any of the sacrifice intervals.
Thus, under experimental conditions chosen here, Mono-n-butylamin-hydrochlorid 63% does not have any clastogenic effect, and there were no indications of any impairment of chromosome distribution in the course of mitosis.
Applicant's summary and conclusion
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