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EC number: 200-751-6 | CAS number: 71-36-3
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-08-19 to 1985-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- secondary source
- Title:
- n-Butanol (CAS No. 71-36-3)
- Author:
- ECETOC
- Year:
- 2 003
- Bibliographic source:
- ECETOC JACC No. 41, ISSN-0773-6339-41, December 2003
- Reference Type:
- secondary source
- Title:
- OECD SIDS n-Butyl Alcohol
- Author:
- OECD
- Year:
- 2 001
- Bibliographic source:
- OECD SIDS, UNEP Publications
Materials and methods
- Principles of method if other than guideline:
- Four groups of male and female rats (30/sex/group) were administered daily by gavage 0, 30, 125 or 500 mg/kg bw/d for either 6 or 13 weeks.
- GLP compliance:
- yes
- Limit test:
- no
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
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - lot: 3597
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan, U.S.A.
- Age at study initiation: 36-37 d
- Mean weight at study initiation: males 90 g, females 86 g
- Housing: individually
- Diet: ad libitum, Purina Certified Rodent Laboratory Chow #5002 (pellet)
- Water: ad libitum, filtered municipal water
- Acclimation period: 7 days before the pretreatment week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1
- Humidity (%): 47.6 +/- 9.2
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dosing solutions of butanol in deionized water were used.
VEHICLE
- Concentration in vehicle: not specified
- Amount of vehicle: 10 mL/kg bw was the constant dosing volume - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC-FI
- Duration of treatment / exposure:
- 6 weeks (42/43 days) for animals used for interim sacrifice or 13 weeks (91/92 days) for complete study
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30 (further 10 were sacrificed prior to dosing for determination of clinicopathological baseline levels)
- Control animals:
- yes, concurrent vehicle
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded weekly
FOOD CONSUMPTION: Yes
-Time schedule: Food consumption was recorded weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Ophthalmic examination was conducted prior to treatment and during week 13 before final necropsy.
- Dose groups that were examined: all rats
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before the start of the study (only baseline group animals), during week 6 (only interim sacrifice animals) and during week 13 (final sacrifice animals)
- Anaesthetic used for blood collection: Yes, CO2
- Animals fasted: No data
- How many animals: 10 males and 10 females/ treatment group
- parameters: hemoglobin ( HGB), hematocrit (PCV), erythrocyte count (RBC), mean cell volume (MCV), mean cell hemoglobin (MCH),mean cell hemoglobin concentration (MCHC) total and differential leucocyte counts (WBC), estimated platelet count (PLT)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: before the start of the study (only baseline group animals), during week 6 (only interim sacrifice animals) and during week 13 (final sacrifice animals)
- Animals fasted: No data
- How many animals: 10 males and 10 females/ treatment group
- parameters: alkaline phosphatase (Alk phos) blood urea nitrogen (BUN), glutamate pyruvate transaminase (SGPT), glutamate oxalacetate transaminase (SGOT), glucose (Gluc), total protein (TP), albumin (Alb), A/G ratio (calculated), globulin (calculated), total bilirubin (Tot. bili.), sodium (Na), potassium (K ), chloride (Cl), calcium (Ca), inorganic phosphate (Phos), carbon dioxide (TCO2), total serum cholesterol (Chol), creatinine.
URINALYSIS: Yes
- Time schedule for collection of urine: before the start of the study, during week 6 and during week 13
- Metabolism cages used for collection of urine: yes, for 4 h
- Animals fasted: No data
- parameters: pH, specfic gravity, glucose, protein, ketones, bilirubin, urobilinogen, microscopy of sediment
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: Ten male and ten female rats from each group were necropsied on study days 43 to 44 and the remaining animals on study days 92 to 93. Gross pathology of all animals was assessed and organs from animals necropsied on study days 92 to 93 were weighed.
HISTOPATHOLOGY: Yes: A complete histopathological investigation was made of all animals of the control and high-dose groups. In the low and mid-dose groups, histopathology included the liver, kidney, and heart from all animals and all gross lesions. All animals found dead or killed in extremis were also microscopically examined.
Tissues examined in control and high dose groups: Heart and attached aorta, thymus, lungs, trachea, esophagus, stomach, salivary glands (mandibular and sublingual glands), small intestine, jejunum, ileum, colon, liver, pancreas, spleen, lymph nodes (mesenteric), kidneys, urinary bladder, adrenal glands, pituitary gland, eyes with optic nerve, thyroid and parathyroid glands, lumbar spinal cord, brain, bone marrow (femur), testes with epididymides, ovaries, uterus, cervix, skin, mammary gland, skeletal muscle, sciatic nerve, tissue masses and all other gross lesions - Statistics:
- Body weight, food consumption, clinicopathologic and organ weight data were tested for homogeneity of variance by Bartlett’s method. If data was homogeneous, differences between control and treatment means were tested for statistical significance by the method of Dunnett. If data was not homogeneous, the method of Gill (modified Dunnett’s) was used.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Ataxia and hypoactivity (lasting less than 1 h) were observed 2 to 3 minutes after dosing in both sexes of the high-dose group (500 mg/kg bw/d) during the final 6 weeks of dosing. Such ataxia and hypoactivity are typically seen following high oral doses of alcohols. The rapid induction/remission of these effects and the reported increased incidence after the interim kill may be due to the fact that personnel were able to collect post-dose observations more quickly since fewer animals required dosing.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No significant changes between treated groups and controls were observed concerning mortality.
One mid-dose male rat died during week 1.
Three rats were found dead or sacrificed in extremis. These deaths could not be attributed to the test article but were related to treatment accidents. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No test substance related changes between treated groups and controls were observed.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No test substance related changes between treated groups and controls were observed.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Chorioretinal hypoplasia was seen in 1 control and low-dose rat and in 3 mid and high-dose rats. This observation is commonly seen in rats of the corresponding age and not test substance related. One other unspecified lesion in one low-dose and one mid-dose rat and 2 in high-dose rats was observed. Those lesions were also considered non treatment related.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At the interim clinical pathological evaluation, red blood cell count (RBC) packed cell volume (PCV), and hemoglobin (HGB) averages of the 500 mg/kg/day dose group females were 5 % below control averages. Although these differences were statistically significant, they were small and no differences between the parameters were observed in the males of the interim evaluation or between control and treated groups of either sex at the final evaluation. Therefore, even if the lower red blood cell parameters in the 500 mg/kg/day females were an actual treatment-related effect, it was small and transitory and thus not considered as adverse.
In addition a higher (p ≤ 0.05) absolute neutrophil count in middle-dose males at interim evaluation, higher (p ≤ 0.05) relative lymphocyte count in low-dose females at final evaluation and a higher urine pH (p ≤ 0.05) in low-dose males (interim) and females (final) were detected. All those effects were statistically significant but small, occurred in one sex and at one time point only without a dose response relationship. Therefore those effects were not considered treatment related. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A lower (p ≤ 0.05) cholesterol average in the high-dose males at interim evaluation was detected. The effect was only observed in one sex at one time point, therefore it was considered not treatment related.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No significant changes between treated groups and controls were observed.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Only in thyroid weight of high-dose males a slight increase was detected. No dose response relationship was observed and the difference was considered to be a chance occurrence and not treatment related.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related lesions were detected. All observed lesions were either in the normal range for the test animal species and age with no differences between control and treated animals or were caused by accidents during treatment.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment related lesions were detected. All observed lesions were in the normal range for the test animal species and age with no differences between control and treated animals.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Key result
- Dose descriptor:
- LOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: transient clinical signs of CNS depression (ataxia and hypoactivity)
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- central nervous system
- Organ:
- other: Not centered on a specific organ but general effects on neurological and behavioral functions as typically observed for alcohols (drowsiness and dizziness).
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
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.
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