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Diss Factsheets
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EC number: 213-156-1 | CAS number: 927-62-8
- 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
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- 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: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards, well documented and acceptable for assessment, males were exposed only 6 weeks prior to mating compared to the 10 weeks recommended by the guidelines 415 and 416 but sufficiently long enough if compared to the screening test (guideline 421) which recommends only 2 weeks of exposure prior to mating. Older male rats were used as can be extrapolated from the initial body weights whereas younger rats are recommended in the guidelines.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
- Principles of method if other than guideline:
- Two concentrations of butan-1-ol (3000 and 6000 ppm) were administered by inhalation to separate groups of 15 pregnant Sprague-Dawley rats for 7 hr per day throughout gestation ; 18 male rats were similarly exposed for 7 hr per day for 6 weeks, and mated to unexposed females.
- GLP compliance:
- no
Test material
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- IUPAC Name:
- butan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 1-butanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: (P) Males: mean: 429-512 g; Females: mean: no data
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: air
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations measured in the exposure chambers approximated the target concentrations of 3000 and 6000 ppm. Mean (±s.d.) 1-butanol concentrations were 3010 (±50) and 6000 (±80) ppm, and results of periodic confirmatory charcoal tube samples were 3000 (± 90) and 5960 (± 110) ppm, respectively .
- Duration of treatment / exposure:
- females: Exposure period: day 1 - 20 of gestation
males: 6 weeks before mating - Frequency of treatment:
- 7 h/d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 3000, 6000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 15 females per dose
18 males per dose - Control animals:
- yes
Examinations
- Statistics:
- Data were analyzed using multivariate analysis of variance (MANOVA) on tests with multiple dependent measures, followed by analysis of variance (ANOVA) on each dependent variable if a significant MANOVA was observed. If only one dependent variable was obtained, ANOVA was used, followed by the Tukey Range Test to determine which cell means differed from one another.
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 18.5 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- other: NOAEL developmental neurotoxicity
- Generation:
- F1
- Effect level:
- 18.5 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observrd
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No general maternal or paternal toxicity was reported. Paternal exposure had no detectable effect on pregnancy rate in non-exposed females; maternal exposure was also without detectable effect on pregnancy rate. Although the study was designed to provide animals for postnatal assessment of developmental neurotoxicity, the lack of effect on pregnancy rate following either maternal or paternal exposure suggested that butan-1 -ol had no effect on fertility up to 6000 ppm. In the 6000 ppm group, 4 of the 78 (5%) behavioural measures, and 4 of the 64 (6%) neurochemical measures differed from those of controls.
There was no discernible pattern of effects.
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.