Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- 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 and Guideline study Please refer to section 13 (read across statement).
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- according to OECD Guideline 414 (Prenatal Developmental Toxicity Study) [see 7.8.2]
- GLP compliance:
- yes
- Limit test:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: K. Thomae GmbH/Boehringer Ingelheim, Biberach/Germany
- Age at study initiation: approx. 70 d
- Weight at study initiation: 198 - 246 g
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d before mating
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:glass-steel inhalation exposure chamber, 1.4 m3, space for 6x6 cages
- Method of holding animals in test chamber: 1 animal/cage
- Source and rate of air: charcoal-filtered air
- System of generating particulates/aerosols: In a thermostated vaporiser (25 - 35 °C), the vapor-air mixture was generated by spraying the TS
with compressed air into a counter current of conditioned air, followed by further mixing with air to achieve required
exposure concentrations.
- Temperature, humidity, pressure in air chamber: 21.2 - 22.5 °C; 50.5 - 62.0 %
- Air change rate: Air changes: 20/hour
TEST ATMOSPHERE
- Brief description of analytical method used: GC/FID after absorption in DMF
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Method: GC with FID detection
- Sampling time: 2 times during each exposure (for controls 2 times during the study) - Duration of treatment / exposure:
- 14 d (6 - 19 day of gestation)
- Frequency of treatment:
- 6 h/d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
51.4 +-2.2; 151.8 +-9.2; and 460 +-17.5 mg/m3 (= 17, 50.1, and 151.8 mL/m3)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 20 - 24 pregnant female rats
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 3x during exposure, other days 1x
BODY WEIGHT: Yes
- Time schedule for examinations: on day 1, 3, 6, 8, 10, 13, 15, 17, 19 and 20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: ovary, uterus, placenta
- macroscopy of dams
- histopathological examination of 4 sections of the nasal cavity
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- - Mortality: none
- Body weight: no treatment related effects
- Clinical signs: no treatment related effects
- Gross pathology incidence and severity: no treatment related effects [incidental congestion, oedema and/or marginal emphysema of the lungs (due to method of sacrifice)
- Histopathology incidence and severity: anterior nasal section showing squamous metaplasia, inflammatory cells and hyperplasia of transitional cells at all concentrations (dose dependent effect). At 450 mg/m3, necrosis of the nasal mucosa (5 animals) and the underlying nasal bone (1 animal).
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- > 17 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Histopathology: nasal irritation
- Dose descriptor:
- NOAEC
- Effect level:
- > 51 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Histopathology: nasal irritation
- Dose descriptor:
- LOAEC
- Effect level:
- 51 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Histopathology: nasal irritation
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Nasal irritation in dams following inhalation exposure to n-butylamine during gestation (14 d)
Percentage of dams showing lesions exposed to the following concentrations in ppm [mg/m3], nominal |
||||
Histopathological findings |
0 |
17 [50] |
50 [150] |
150 [450] |
Squamous cell metaplasia |
No data |
10 |
50 |
100 |
Purulent to mixed inflammatory cell infiltration |
No data |
30 |
90 |
100 |
Focal necrosis of nasal mucosa |
No data |
0 |
0 |
50 |
Necrosis of nasal bone |
No data |
0 |
0 |
10 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.