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EC number: 212-740-3 | CAS number: 865-47-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to NTP standard, is well documented and suitable for assessement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
- Principles of method if other than guideline:
- Study was performed as a dose-finding study for a 2-yr study.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylpropan-2-ol
- EC Number:
- 200-889-7
- EC Name:
- 2-methylpropan-2-ol
- Cas Number:
- 75-65-0
- Molecular formula:
- C4H10O
- IUPAC Name:
- 2-methylpropan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): t-butyl alcohol
- Physical state: clear colorless liquid
- Analytical purity: > 99 %
- Lot/batch No.: F112784
- Stability: bulk chemical is stable for 2 weeks
- Stability under test conditions: The stability of the dose formulations was at least 3 weeks at room temperature when stored in the dark and at least 3 days at room temperature under normal room light.
- Storage condition of test material: it should be protected from light at temperatures up to 60 °C
- Other: t-Butyl alcohol was manufactured by FBC Chemical Corp., Lancaster, NY, USA; On the first, middle, and last mixes, dosage analyses (gas chromatography) both prior to and after dosing confirmed that the dosage formulations were within ±10% of the target concentrations.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Facility (Frederick, MD, USA)
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: male: 22.3 g; female: 17.5 g
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): deionized water; ad libitum
- Acclimation period/quarantine: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 12-30 °C
- Humidity (%): 31-56 %
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The solutions were prepared by mixing t-butyl alcohol with deionized water. The stability studies of a 0.5 mg/mL dose formulations were performed by the analytical chemistry laboratory using the technique of gas chromatography. The stability was at least 3 weeks at room temperature when stored in the dark and for at least 3 days at room temperature under normal room light.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 94-95 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2.5, 5, 10, 20, or 40 mg/mL
Basis:
nominal in water
- No. of animals per sex per dose:
- 10 animals/dose and sex
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The chosen doses were based on an unpublished 14-day study previously conducted for NTP.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: initially, than weekly, and at the end of the study
FOOD EFFICIENCY:
- Body weight gain: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the study
- How many animals: all animals
- Parameters checked were: hematocrit, hemoglobin, erythrocytes, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelets, reticulocytes, leukocytes, segmented neutrophils, bands, lymphocytes, monocytes, eosinophils
OTHER: Samples were collected to analyse sperm morphology and vaginal cytology from all mice in all exposure groups. Here, sperm count, morphology, and motility were determined. The right cauda, right epididymis, and right testis were weighed. Vaginal samples were collected for up to 7 consecutive days prior to the end of studies from all female animals to analyse vaginal cytology. The parameters were: relative frequency of estrous stages and estrous cycle length.
Organ weights were determined from brain, heart, right kidney, liver, lungs, and thymus
Tissues examined: adrenal gland, bone (marrow, femur, sternum), brain, esophagus, gallbladder, heart, large intestine (cecum, colon, rectum), small intestine (duodenum, jejunum, ileum), kidney, liver, lung, lymph node (mandibular and mesenteric), mammary gland, nose, ovary, pancreas, pituitary gland, parathyroid gland, prostate gland, salivary gland, skin, spleen, stomach (forestomach and glandular stomach), testis (epididymis and seminal vesicle), thymus, thyroid gland, trachea, urinary bladder, and uterus. - Sacrifice and pathology:
- Animals were sacrificed by carbon dioxide
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, on all mice in the 0 and 40 mg/mL groups, on 20 mg/mL male mice, and on one 2.5 mg/mL female mouse
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: One vehicle male, and one 2.5 and one 20 mg/mL female died. 6/10 male animals and 4/10 females died at 40 mg/mL. As written by the authors, the deaths of two male and one female at the given dose of 40 mg/mL were attributed to exposure to t-butyl alcohol; all other deaths were considered unrelated to chemical administration. Clinical signs included emaciation, ataxia, and hypoactivity at 40 mg/mL in males and emaciation at 40 mg/mL in females
BODY WEIGHT AND WEIGHT GAIN: Significantly reduced body weight gain occurred in males at 20 mg/mL (30 %) and at 40 mg/mL (54 %) and in females at a concentration of 40 mg/mL (27 %). At a dose of 10 mg/kg, a not significant decrease in body weight gain occurred indicating dose-dependency.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Resulted in no significant or dose-related changes compared to control group
HAEMATOLOGY: Erythrocyte counts and hemoglobin as well as hematocrit values were minimally increased in male animals at a concentration of 40 mg/mL, and (less consistently) at an applied dose of 20 mg/mL in males and females, suggesting hemoconcentration resulting from slight dehydration.
ORGAN WEIGHTS: Absolute and relative kidney weights at a concentration of 40 mg/mL in females were significantly greater than those of the controls.
HISTOPATHOLOGY: NON-NEOPLASTIC: Hyperplasia of the urinary bladder transitional epithelium was present in all male and three female mice at the dose of 40 mg/mL and in six male animals receiving 20 mg/mL. Chronic inflammation of the urinary bladder could be shown in all males and six females receiving 40 mg/mL and six male animals at 20 mg/mL. But in general, urinary bladder lesions were higher in males than in females.
OTHER FINDINGS: No significant changes regarding sperm morphology or motility or the percentage of time spent in the various estrous cycles occurred; however, estrous cycle length was significantly increased in females receiving 40 mg/mL test substance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 10 other: mg/mL drinking water
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased body weight gain
- Dose descriptor:
- NOEL
- Effect level:
- ca. 10 other: mg/mL drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Hyperplasia of the transitional epithelium of the urinary bladder and urinary bladder inflammation, increased hematology data for hemoglobin, hematocrit, and erythrocytes
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
In summary, the urinary tract is the target tissue for t-butyl alcohol toxicity in mice.
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