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Diss Factsheets
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EC number: 201-195-7 | CAS number: 79-31-2
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Relevant methodological deficiencies
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Type: other: andrological measures (testicular homogenization resistent (late step) spermatid head count, testicular staging, epididymal spermatozoan count)
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 2-methylpropan-1-ol
- EC Number:
- 201-148-0
- EC Name:
- 2-methylpropan-1-ol
- Cas Number:
- 78-83-1
- Molecular formula:
- C4H10O
- IUPAC Name:
- 2-methylpropan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): isobutanol, 2-methyl propanol (obtained from Union Carbide Chemicals and Plastics Company, Houston, TX, USA
- Physical state: colorless, volatile organic liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Laboratories Inc., NC, USA
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males 285 - 365 g, females 179 - 242 g
- Fasting period before study: no data- Housing: individually in stainless steel wire-mesh cages
- Diet (e.g. ad libitum): Purina Mills rodent Lab Chow #5002
- Water (e.g. ad libitum): yes- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -26-
Humidity (%): 30 - 70
- Air changes (per hr): nodata
- Photoperiod (hrs dark / hrs light): 12 /12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 2000 L stainless steel and glass Hazelton H-2000 chambers
- Method of holding animals in test chamber: individually caged
- Source and rate of air: 500 L/minute
- Method of conditioning air: no data
- System of generating particulates/aerosols: adjustable-flow valveless metering pump (Fluid Metering Inc., Oster Bay, NY, USA) and a Laskin-typ nebulizer mounted in the supply air inlet at the top of the exposure chamber
- Temperature, humidity, pressure in air chamber: 23 to 24°C, 48 to 53%, no data
- Air flow rate: appr. 500 L/minute
- Air change rate: 15 changes/hour
- Method of particle size determination: no data
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: Fourier Transform infrared analyzer (FVB / Analect, Irvine, CA, USA) calibrated for isobutanol
- Samples taken from breathing zone: yes; 18 samples per exposure - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical determinations of the exposure chamber concentration yielded nominal-to-analytical ratios of means between 0.95 and 0.97
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 1000, and 2500 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- control and 2500 ppm groups: 20
250 ppm and 1000 ppm groups: 10 - Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: preliminary study (5 rats/sex, 0, 750, 1500, and 3000 ppm)
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no satelite groups - Statistics:
- For parametric data Bartlett's test for homogenmeity of variances, analysis of variance (ANOVA) for overall significance, Dunnett's test for comparison of dosed groups to the controls.
For nonparametric and percentage based data Kruskal-Wallis test for the overall analysis, Mann Whitney U test for pairwise comparisons to the controls.
for normality of distribution
Results and discussion
Observed effects
Any other information on results incl. tables
(1) No changes in epididymal sperm count were detected in any exposure group.
(2) Total spermatid counts (on a per mg testis basis) were significantly higher in the mid-dose group (p<0.05).
Control 250 ppm 1000 ppm 2500 ppm
------------------------------------------
n= 15 5 5 15
------------------------------------------
Testes
weight (g) 1.90 1.75 1.95 1.85
no. spermatids
(x10E06) 101 117 167* 115
Spermatids (x10E03)
/mg tissue 53 67 86* 63
------------------------------------------
Epididymis
weight (g) 709 716 747 694
spermatozoa 48 69 68 57
(x10E06)
spermatozoa (x10E03)
/mg tissue 67 100 92 83
------------------------------------------
Stage XIII
(%) 8.1 8.6 7.6 10.6*
------------------------------------------
*=p<0.05; ANOVA, Dunnett's, 2-tailed
(3) Statistically significant (although minimal) increases in
the frequency of stage XIII in the 2500 exposure group were
observed.
There were no major changes to the seminiferous epithelium (histopathology; Monsanto 1995) or reduction in the number of spermatozoa available for fertilization of the ova.
Applicant's summary and conclusion
- Conclusions:
- Due to methodological deficiencies, the study results are not conclusive. Combined evidence (no dose-dependent effect on spermatid head count and spermatozoa count) indicates that testicular functions are not affecte by isobutanol treatment of test animals. This finding is supported by the results from a 2-generation reproductive toxicity inhalation study.
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