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Diss Factsheets
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EC number: 227-006-8 | CAS number: 5593-70-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reference
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- 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
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS [please address all points below]:
- Premating exposure duration for parental (P0) animals
- Basis for dose level selection
- Inclusion/exclusion of extension of Cohort 1B
- Termination time for F2
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B
- Inclusion/exclusion of developmental immunotoxicity Cohort 3
- Route of administration
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals [if applicable] - 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 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- 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
- Remarks:
- Doses / Concentrations:
0, 3 000, 6 000 ppm
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
0, 9 250, 18 500 mg/m3 air
Basis:
nominal conc. - No. of animals per sex per dose:
- 15 females per dose
18 males per dose - Control animals:
- yes
- 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.
- Dose descriptor:
- NOAEC
- Effect level:
- 18 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Pregnancy rate
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- 18 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Developmental neurotoxicity
- Reproductive effects observed:
- not specified
- Conclusions:
- Female rats exposed to 6 000 ppm (18 500 mg/m3) n-butanol throughout gestation and male rats exposed to 6 000 ppm (18 500 mg/m3) n-butanol for six weeks prior to mating showed no effects on fertility or pregnancy rate.
- Executive summary:
In a reliable developmental neurotoxicity study groups of 18 male Sprague-Dawley rats were exposed to concentrations of 0, 3000, or 6 000 ppm n-butanol for 7 hours/day for 6 weeks. These males were then mated to non-exposed female rats of the same strain. In a separate experiment, groups of 15 pregnant female rats were exposed to concentrations of 0, 3 000, or 6 000 ppm for 7 hours/day from gestation Day 1-20. These females were then allowed to deliver. The offspring from these two groups were then observed for signs of developmental neurotoxic effects. Offspring were examined from postnatal days 10-90 for the following measures: ascent on a wire mesh screen, rotorod, open-field and photoelectrically-monitored activity, running wheel, avoidance conditioning, operant conditioning. Acetylcholine, dopamine, norepinephrine, serotonin, met-enkephalin, beta-endorphin and substance P neurotransmitter levels were measured from the cerebrum, cerebellum, brainstem, and midbrain.
No detectable effect on pregnancy rate was found after either maternal or paternal exposure. In the 6 000 ppm (18 500 mg/m3) group, 4 of the 78 (5%) behavioral measures, and 4 of the 64 (6%) neurochemical measures differed from those of controls. However, no dose-response correlation was observed. Thus, the NOAEL for the P and F1 generation is 18 500 mg/m3.
Read-across justifications and data matrices are presented in IUCLID section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Behavioral Teratology Investigation of 1-Butanol in Rats
- Author:
- Nelson BK, Brightwell WS, Robertson SK, Kahn A, Krieg Jr EF, Massari VJ
- Year:
- 1 989
- Bibliographic source:
- Neurotoxicology and Teratology 11: 313-315
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
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS [please address all points below]:
- Premating exposure duration for parental (P0) animals
- Basis for dose level selection
- Inclusion/exclusion of extension of Cohort 1B
- Termination time for F2
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B
- Inclusion/exclusion of developmental immunotoxicity Cohort 3
- Route of administration
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals [if applicable]
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:
- 1-Butanol
- Details on test material:
- Name of test material (as cited in publication): 1-butanol
Constituent 1
Constituent 2
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:
- 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 / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 3 000, 6 000 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 9 250, 18 500 mg/m3 air
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:
- NOAEC
- Effect level:
- 18 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Pregnancy rate
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- 18 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Developmental neurotoxicity
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Read-across justifications and data matrices are presented in IUCLID section 13.
Applicant's summary and conclusion
- Conclusions:
- Female rats exposed to 6 000 ppm (18 500 mg/m3) n-butanol throughout gestation and male rats exposed to 6 000 ppm (18 500 mg/m3) n-butanol for six weeks prior to mating showed no effects on fertility or pregnancy rate.
- Executive summary:
In a reliable developmental neurotoxicity study groups of 18 male Sprague-Dawley rats were exposed to concentrations of 0, 3000, or 6 000 ppm n-butanol for 7 hours/day for 6 weeks. These males were then mated to non-exposed female rats of the same strain. In a separate experiment, groups of 15 pregnant female rats were exposed to concentrations of 0, 3 000, or 6 000 ppm for 7 hours/day from gestation Day 1-20. These females were then allowed to deliver. The offspring from these two groups were then observed for signs of developmental neurotoxic effects. Offspring were examined from postnatal days 10-90 for the following measures: ascent on a wire mesh screen, rotorod, open-field and photoelectrically-monitored activity, running wheel, avoidance conditioning, operant conditioning. Acetylcholine, dopamine, norepinephrine, serotonin, met-enkephalin, beta-endorphin and substance P neurotransmitter levels were measured from the cerebrum, cerebellum, brainstem, and midbrain.
No detectable effect on pregnancy rate was found after either maternal or paternal exposure. In the 6 000 ppm (18 500 mg/m3) group, 4 of the 78 (5%) behavioral measures, and 4 of the 64 (6%) neurochemical measures differed from those of controls. However, no dose-response correlation was observed. Thus, the NOAEL for the P and F1 generation is 18 500 mg/m3.
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.
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