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EC number: 221-394-2 | CAS number: 3085-30-1
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxic Effects of Subchronic Combined Exposure to N-butylalcohol and m-Xylene in rats
- Author:
- Korsak et al.
- Year:
- 1 994
- Bibliographic source:
- International Journal of Occupational Medicine and Environmental Health, Vol. 7, N o 2, 155—166, 1994
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Version / remarks:
- 3 month toxicity study studying a limited number of endpoints
- Principles of method if other than guideline:
- In this study only a limited number of endpoints was included (see below)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Imp: DAK stock
- Age at study initiation:no data
- Weight at study initiation:322-329 g
- Housing: no data
- Diet/water: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C):no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE: no data (generated by heating liquid solvents in washers)
CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation chamber (1.3 m 3 volume).
- Method of holding animals in test chamber: no data
TEST ATMOSPHERE
- Brief description of analytical method used: GC with FID with 1.5 m metal column with 10% QV-17 on chromasorb W H P (80—100 mesh) as a stationary phase at column temperature of 100°C.
- Samples taken from breathing zone: no data (samples taken every 30 min)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC with FID with 1.5 m metal column with 10% QV-17 on chromasorb W H P (80—100 mesh) as a stationary phase at column temperature of 100°C.
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- 6 hours/day, 5 days/week for 3 months.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 154 mg/m³ air
- Dose / conc.:
- 308 mg/m³ air
- No. of animals per sex per dose:
- 12/concentration (24 for controls)
- Control animals:
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before exposure and 1 week before termination
- Anaesthetic used for blood collection: no
- Animals fasted: Not specified
- How many animals: not specified
- Parameters checked: Erythrocyte count,
hemoglobin concentration, hematocrit, leucocyte count and differential leukocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 24 h before termination of exposure
- Anaesthetic used for blood collection: yes, ether
- Animals fasted: Yes 24 hours before
- How many animals:no data
- Parameters checked: alanine aminotransferase, aspartate aminotransferase, sorbitol dehydrogenase, alkaline phosphatase, total protein, albumin and glucose, and electrolytes — sodium, potassium, calcium, chloride
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: rotarod performeance once per month; hot plate response (latency of paw-lick response) at study termination
- Dose groups that were examined: all - Sacrifice and pathology:
- Organ weights: heart, lungs, liver, spleen, kidneys, adrenals, testes
Liver: microsomal monooxygenases and lipid peroxidation
livers were homogenized to yield a 25% homogenate.
The activity of aniline p-hydroxylase (EC 1.14.1.1) was assayed in 9000 g postmitochondrial supernatants of the liver according to Holtzman and Gillette (6) as adopted by Wiśniewska-Knypl and Jabłońska (21).
In liver microsome Cytochrome P —450 was determined according to Omura and Sato by Carbon monoxidedifference spectra of dithionite-reduced microsomes between 490 and 450 nm using Beckman ACTA CIII spectrophotometr and extinction coeficient of 91 m m ol-1 cm -1 was employed for quantifying cytochrome P —450.
Lipid peroxidation in fresh microsomal membranes was evaluated on the basis of detection of thiobarbituric acidreactive substance according to M ihara et al
An extinction coefficient of 1.56 x 10-5 m m ol-1 according to Wills (20) was used for malondialdehyde formation.
For assay of triglycerides, hepatic lipids were extracted by the method of Folch et al. (4): liver slices were homogenized with 20 volumes of chloroform-methanol (2:1, v/v) at 45°C and the extract washed with 0.1 mol NaCl, evaporated under vacuum and the residues dissolved in chloroform. Triglycerides were determined with a standard enzymatic kit of Boehringer-Mannheim.
“Test Combination-Triglycerides (neutral fat)” taking for analysis a lipid extract equivalent to 10 — 20 mg of fresh liver, and the decrease of NADH was
measured at 340 nm in a Perkin-Elmer Lambda 15 spectrophotometer. Concentration of triglycerides in the liver were adapted for nmol per g tissue using a factor 1.14 (mol wt. of glycerol trioleate = 885.4). - Statistics:
- ANOVA, Dunnet's test and Fisher Exact test
Results and discussion
Results of examinations
- Clinical signs:
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- at both concentration significantly increased after 1 and 2 months (no relationhip with dose). No effect at 3 months
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- sign decreased Hb at both concentrations (no concentration response relationship)
sign decreased red bloodcells at high concentration (decreased at low concentration) --> related with concentration
sign increase of eosinophils at high concentration (increased at low concentration) --> related with concentration - Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Dose related significant increase of failures in rotarod test (increasing over time)
Significant decrease of decrease in latency of the paw-lick response at low and high concentration (no concentration related effect) - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- sign dose related increase of lipid peroxidation (15% at low concentration and 30% at high concentration)
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 154 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- haematology
- other: effect on lipid peroxidation
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 154 mg/m³ air
- System:
- other: behavioural effects
- Organ:
- other: cannot be specified
- Treatment related:
- yes
- Dose response relationship:
- yes
Any other information on results incl. tables
The endpoints investigated in this study are too limited to allow a defnitive conclusion on 1 -butanol toxicity after repeated inhalation exposure.
Applicant's summary and conclusion
- Conclusions:
- Effects of butanol on behaviour and lipid peroxidation in in liver cells became apparent at 154 mg/m3
- Executive summary:
Rats were exposed to vapours of n-butanol at concentrations of 50 and 100 ppm 6 h/day, 5 days/week for 3 months (154 and 308 mg/m3). No significant changes in body weight gain, in absolute and relative organ weights and clinical biochemistry parameters were observed. N-butanol caused significant disturbances of motor coordination disturbances at 100 ppm. Significant increase in sensitivity to pain in animals exposed to n-butyl alcohol was observed. N-Butyl alcohol provoked the increase of lipid peroxidation in hepatic microsomes without any induction of cytochrome P450 monooxygenases.
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