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EC number: 221-394-2 | CAS number: 3085-30-1
- 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:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of the effect of n-butanol given to female rats in drinking water on fertility and prenatal development of their offspring
- Author:
- Sitarek K, Berlinska B, Baranski B
- Year:
- 1 994
- Bibliographic source:
- International Journal of Occupational Medicine and Environmental Health 7(4): 365-370
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats were given aqueous solutions of n-butanol containing 0.24, 0.8 and 4% n-butanol (0.3; 1.0 and 5.0 g/kg/day) for 8 weeks before and during gestation. The control animals received tap water. The experiment was performed in two stages. The first comprised of the assessment of the oestrous cycle before exposure and then during 4-5 and 7-8 weeks of exposure, and the second stage of the fertility of female rats and their foetal development.
- GLP compliance:
- not specified
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
- Details on test material:
- - Name of test material (as cited in study report): n-butyl alcohol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Own breeding colony (Imp:DAK)
- Age at study initiation:10 wks (females)
- Weight at study initiation: Females: 180-200 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22 °C
- Humidity (%): 45-55 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
the test substance was mixed with drinking water, the stability of the aqueous n-butyl alcohol solutions was assessed on several consecutive days - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the aqueous n-butyl alcohol solutions was assessed on several consecutive days after their preparation using a Varian Aerograph 2800 gas chromatograph equipped with FID. The column was glass (2 in x 2 mm id .) packed with Porapak Q. The operating conditions were; carrier gas flow (nitrogen) 30 cm3/min ; hydrogen 30 cm3/min ; air 300 cm3/min; the temperature of the column, injection part and detector were 200°C, 200°C, 230°C, respectively. It was determined that the aqueous n-butyl alcohol solutions were stable within the concentration range used in the experiment (0.24-4%).
- Details on mating procedure:
- - Impregnation procedure: [cohoused]
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: 3 weeks with untreated males
- Verification of same strain and source of both sexes: [yes]
- Proof of pregnancy: [sperm in vaginal smear] referred to as [day 0] of pregnancy - Duration of treatment / exposure:
- Exposure period: 8 weeks premating, mating (max. 3 weeks) , gestation day 0 - 20
- Frequency of treatment:
- daily, continuous
- Duration of test:
- until day 20 of gestation
- No. of animals per sex per dose:
- 11-17 females per dose
- Control animals:
- yes
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: The general behaviour of the animals was observed throughout the experiment.
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Weight gain was monitored every week in the nonpregnant females and on days 3, 7, 10 and 17 of gestation in the pregnant animals
FOOD CONSUMPTION:
- The daily intake of food was monitored every week in the nonpregnant females and on days 3, 7, 10 and 17 of gestation in the pregnant animals.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: The daily intake of water or n-butanol solutions was monitored every week in the nonpregnant females and on days 3, 7, 10 and 17 of gestation in the pregnant animals.
POST-MORTEM EXAMINATIONS: No data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [half per litter]
- Skeletal examinations: Yes: [half per litter]
- Head examinations: No data - Statistics:
- In the case of variance homogeneity, one-way variance analysis and Dunnett tests were used; in the case of heterogeneity Kruskal-Wallis variance analysis was followed by non-parametric tests. Frequency data was analyzed with a Fisher exact probability test. The consumption of food and water or n-butanol solution, and body weight gain of dams were evaluated with two-way variance analysis and Scheffe test for multiple comparison.
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Haematological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
Maternal developmental toxicity
- Pre- and post-implantation loss:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Details on maternal toxic effects:
The general appearance and behaviour of the animals exposed to n-butyl alcohol given in drinking water during the 8 weeks, as well as body weight gain, food and liquid intake were similar to that of the control animals . There were no cases of mortality in either group.
Integral toxicity indexes observed in the female rats, such as body weight gain during gestation, food and liquid (water or butanol solutions) intake, absolute and relative organ weights, hemoglobin concentration and haematocrit values did not differ between the exposed and control groups.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
The unit of statistical analysis in this study was the individual foetus, not the litter.
At 5000 mg/kg bw the crown-rump length was decreased (mean of 4.0 to 3.8 cm for the control and treated group, respectively) . Developmental effects were reported in all 3 dose groups. Skeletal effects were limited to an extra 14th rib in 1 foetus in the low dose group and 2 foetuses in the high dose group, and wavy ribs in 1 foetus in the low dose group. CNS defects included dilation of either the subarachnoid space or lateral and/or third ventricles of the brain, or external or internal hydrocephalus. Dilated renal pelves were also observed. Of the 65 control foetuses examined for skeletal effects, none had an extra fourteenth or wavy rib(s) or any other skeletal malformation or variation. Two of the 61 control foetuses examined for visceral anomalies had dilatation of the lateral and/or third ventricles of the brain, while none had dilatation of the subarachnoid spaceor external or internal hydrocephalus. Although the authors considered all 3 dose levels as related to increased foetal effects when compared to controls, there was no dosedependent increase. However, since no foetus of the middle dose group was affected, and only 2 in the low dose, it appears probable that the observations in the low dose group were not treatment related.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The unit of statistical analysis in this study was the individual foetus, not the litter.
The authors considered the recorded developmental effects (dilatation of the brain ventricles/spaces or renal pelvis, internal hydrocephalus, wavy or extra ribs) as being related to butan-1-ol and assessed these findings as variations or delayed development commonly seen in large historical control databases. Of significance, the incidence of all but one of the reported developmental effects in the actual control population was 0%. In the MARTA-MTA 1995 database, using Crl: CD BR rat, the incidence of "cerebral ventricle, enlargement" was 2%/foetus or 4.4%/litter, and the incidence of "renal pelvis, dilated" 0.95%/foetus or 5.2%/litter (Wise and Petrere, 1996). The "malformations" reported that were assessed as "variations" in other databases should be classified based on the incidence within the rat strain. The incidence of variations within the rat strain used in this study is unknown, since the authors used a rat strain common only to their laboratory. The laboratory diet was also unique. Since the strain of rat and type and quality of diet can have profound effects on rates of variations and malformations, and since there is no historical database available for the strain tested, the term “variation" has to be assigned with reservation. However, the term may still be appropriate since the variations reported are also common in several rat strains frequently used in the. In fact, Nelson et al (1989) described some of these variations following inhalation exposure to butan-1-ol. It should not be surprising that high oral doses of butan-1 -ol (corresponding to approx. twice the LD50) that alter normal maternal physiology would also cause an increase in common variations in laboratory rodents. Thus, the developmental effects seen by Sitarek et al (1994) cannot be regarded as a selective foetal effect.
Skeletal and visceral observation
Control | n-butanol 0.3 g/kg/day | n-butanol 1.0 g/kg/day | n-butanol 5.0 g/kg/day | |
No. of foetuses (litters) examined: | 126(12) | 154(14) | 146(12) | 102(9) |
Visceral observation | ||||
No. of foetuses (litters) examined: | 61(12) | 73(14) | 71(12) | 51(9) |
% of foetuses (litters) | ||||
with dilation of: | 2(8) | 25*(64)* | 32*(83)* | 41*(100)* |
subarachnoid space | 0 | 3(14)* | 10*(25)* | 20*(78)* |
lateral ventricle and/or third ventricle of the brain | 2(8( | 23*(57)* | 17*(67)* | 25*(78)* |
unilateral renal pelvis | 0 | 0 | 7*(42)* | 0 |
bilateral renal pelvis | 0 | 0 | 4(25) | 0 |
% of foetuses (litters) with | ||||
congenital defects: | 0 | 0 | 7*(33)* | 4(22)* |
external hydrocephalus | 0 | 0 | 3*(17)* | 0 |
internal hydrocephalus | 0 | 0 | 7*(25)* | 4(22)* |
Skeletal observations | ||||
No. of foetuses (litters) examined: | 65(12) | 81(14) | 75(12) | 51(9) |
% of foetuses (litters) | ||||
with delayed ossification: | 15(67) | 16(50) | 24(58) | 33*(67) |
% of foetuses (litters) | ||||
with congenital defect: | 0 | 1(7)* | 0 | 2(11)* |
14th rib | 0 | 0 | 0 | 2(11)* |
wavy ribs | 0 | 1(7)* | 0 | 0 |
* significantly different from the control (p<0.05)
Applicant's summary and conclusion
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