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EC number: 252-036-3 | CAS number: 34451-19-9
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Behavioral Teratology Investigation of 1-Butanol in Rats
- Author:
- Nelson B.K., Brightwell, W.S., Robertson S.K., Khan A., Krieg Jr. E.F., Massari V.J.
- Year:
- 1 989
- Bibliographic source:
- Neurotoxicology and Teratology 11, 313-315
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: In a behavioural teratology study, 1-butanol at concentrations of 3000 and 6000 ppm was administered by inhalation to groups of 15 pregnant Sprague-Dawley rats for 7 h/day throughout gestation. Similarly, 18 male rats were exposed with the same concentrations for 7 h/day for 6 weeks and mated to unexposed females.
- Parameters analysed/observed: The offspring of both cohorts were evaluated for signs of developmental neurotoxicity (ascent on a wire mesh screen, rotorod, open field and photoelectrically-monitored activity, running wheel, avoidance conditioning and operant conditioning). Further, brains from 10 offspring were dissected into cerebrum, cerebellum, brainstem, and midbrain on post-natal day 21. Each sample was assayed for protein and the neurotransmitters acetylcholine, dopamine, norepinephrine, serotonin, met-enkephalin, beta-endorphin, and substance P. - GLP compliance:
- not specified
- 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
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material in the study: 1-butanol
- Purity: ≥ 99 %
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: Males: 429 to 512 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- Exposure was carried out in exposure chambers. No other information on exposure was mentioned in the publication.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- No details on analytical verification of doses were provided. It is stated that concentrations were measured in exposure chambers and charcoal tube samples were collected for periodic confirmatory of concentrations.
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- For the "maternal exposure group" exposure was conducted during days 1-20 of gestation. For the "paternal exposure group" exposure was conducted for 6 weeks.
- Frequency of treatment:
- 7 hours per day
- Duration of test:
- Offspring were evaluated from days 10-90 post delivery.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Remarks:
- Control
- Dose / conc.:
- 3 000 ppm (nominal)
- Dose / conc.:
- 6 000 ppm (nominal)
- No. of animals per sex per dose:
- 18 males (paternal exposure group) and 15 females (maternal exposure group).
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Based upon the results of beforehand conducted teratology study, 6000 ppm was selected as the high concentration (due to slight maternal toxicity) and 3000 ppm was the low concentration evaluated.
Examinations
- Maternal examinations:
- See box "Any other information on materials and methods incl. tables".
- Ovaries and uterine content:
- n.a.
- Fetal examinations:
- See box "Any other information on materials and methods incl. tables".
- Statistics:
- Data were analysed 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.
- Historical control data:
- No data provided
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not specified
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- not examined
- Other effects:
- not examined
- Details on maternal toxic effects:
- Inhalation of 3000 and 6000 ppm had no detectable effect on pregnancy rate after either maternal or paternal exposure.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- 6 000 ppm (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed
Maternal abnormalities
- Abnormalities:
- not examined
Results (fetuses)
- Fetal body weight changes:
- not examined
- Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- not examined
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Results from behavioural testing of the offspring indicated that there were no significant effects in the ascent test, in the rotorod performance test, on open field performance or operant conditioning. In the photoelectric activity monitor, the counts were significantly lower than controls in the female offspring from paternal animals exposed to 3000 ppm. Analysis of neurotransmitter concentrations in the brains of offspring revealed statistically significant increases in the overall concentration of serotonin (14.48 ± 2.38 vs.7.802 ± 1.48 in controls) and dopamine (0.715 ± 0.127 versus 0.515 ± 0.095 in controls) in offspring of the 6000 ppm group. There were no other statistically significant changes in neurotransmitter concentrations associated with exposure. The data from all tests in this study were within the control data in other research conducted by this laboratory.
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 6 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Any other information on results incl. tables
Analytical results:
Concentrations measured in the exposure chambers approximated the target concentrations of 3000 and 6000 ppm. Mean concentrations were 3010 ± 50 and 6000 ± 80 ppm. Results of periodic confirmatory charcoal tube samples were 3000 ± 90 and 5960 ± 110 ppm.
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were observed in a behavioural teratology study in rats after exposure to n-butanol. Based on the results, the NOAEL for maternal and paternal animals and their offspring was 6000 ppm.
- Executive summary:
In a behavioural teratology study, n-butanol (≥ 99 % purity) was administered to 15 pregnant Sprague-Dawley rats for 7 h/day throughout gestation (GD 1–20) at doses of 0, 3000 and 6000 ppm and were allowed to deliver. In addition, 18 male rats were exposed with the same concentrations for 7 h/day for 6 weeks and were then mated to non-exposed females. The offspring of both cohorts were observed during postnatal days 10–90 for signs of developmental neurotoxic effects by measuring ascent on a wire mesh screen, rotarod and running wheel performance, open-field and photoelectrically-monitored activity, avoidance conditioning and operand conditioning. In addition, the levels of the neurotransmitters acetylcholine, dopamine, norepinephrine, serotonin, met-encephalin, ß.endorphin and substance P were measured in 4 brain regions (cerebrum, cerebellum, brainstem and midbrain) taken from animals on day 21 after birth. No effects on pregnancy rate was found and no general toxicity to maternal and paternal animals was reported. A small number of effects were seen on both the behavioural and neurochemical measures following exposure to 6000 ppm n-butanol, but that no discernable pattern of effects was apparent. Therefore, the NOAEC for maternal, paternal and their offspring was 6000 ppm, which corresponds to 18152 mg/m³.
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