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EC number: 200-908-9 | CAS number: 75-85-4
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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: Well described publication and suitable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- The effects of prenatal tertiary butanol administration in CBA/J and C57BL/6J mice
- Author:
- Faulkner TP, Wiechart JD, Hartman DM, Hussain AS
- Year:
- 1 989
- Bibliographic source:
- Life Sciences, volume 45, pages 1989-1995
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pregnant mice were given tertiary butanol by gavage twice daily from day 6 through day 18 of gestation. Examinations were made on day 18.
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): tertiary butanol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J and C57BL/6J
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME, USA
- Age at study initiation: 25 - 30 weeks
- Diet: standard lab chow; ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug day 0 of pregnancy - Duration of treatment / exposure:
- 13 days (from day 6 through day 18 of gestation.)
- Frequency of treatment:
- twice a day (every 12 hour)
- Duration of test:
- The female mice were sacrificed on day 18 by decapitation.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20 mL/kg bw /day of a 10% (v/v) solution
Basis:
other: nominal conc. 20 ml/kg bw of a 10% (v/v) solution every 12 hours
- Remarks:
- Doses / Concentrations:
21 mmoles / kg bw /day = 1556 mg/kg bw/day
Basis:
other: nominal conc. 10.5 mmoles/ kg bw (=778 mg/ kg bw every 12 hours)
- No. of animals per sex per dose:
- CBA/J control: 7 females
CBA/J t-butanol: 12 females
C57BL/6J control: 5 females
C57BL/6J t-butanol: 9 females - Control animals:
- yes, concurrent vehicle
Examinations
- Ovaries and uterine content:
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of live fetuses: Yes- Fetal examinations:
- - External examinations: no data
- Soft tissue examinations: Yes (half per litter)
- Skeletal examinations: Yes (half per litter)
- Head examinations: no data
- Mean fetal weight: Yes (all per litter) - Statistics:
- A two way analysis of variance (strain x treatment) was used in comparing the mean numbers of viable fetuses, resorptions and abnormalities per litter between treatment groups. Treatment effects on fetal weight within each strain were analyzed by Student's t test. Chi2-Yates was used to compare the number of litters with resorptions or 100% resorptions between treatment groups.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The effects of t-butanol treatment on fetal resorptions and the weight of the surviving fetuses: Tertiary butanol produced a significant increase in the number of resorptions per litter, F(1,29)=7.361, p.=0.011, and a significant decrease in the number of live fetuses per litter, F(1,29)=10.060, p.=0.004. There were no significant effects of strain on either the number of resorptions per litter, F(1,29)=0.07, p.=0.787, or the
number of live fetuses per litter, F(1,29)=0.322, p.=0.575. Eight of the 21 litters in the t-butanol treated groups had all of the fetuses resorbed vs.
none in the control groups (X2=4.10, p.<0.05). Significantly more of the resorptions in the treated groups (33/75) required ammonium sulfide for
visualization than in the control groups (2/14) (X2=4.66, p.<0.05), suggesting an early effect on fetal viability. No inter-strain differences in fetal
mortality were observed. There was a slight but statistically insignificant decrease in the weight of the surviving fetuses in both strains.
The results of morphological examination of the surviving offspring: Soft tissue examination revealed no teratogenic effects of t-butanol in either strain. There was no evidence that t-butanol produced the dilated ventricles, open eyelids, exencephaly, heart defects, or gastroschisis reported for ethanol in the CBA/J strain (27), even though fetuses were carefully examined for these defects. Skeletal examinations showed defects limited to the skull and sternum. Minor variations (misaligned or underossified sternebrae and underossified supraoccipital bones) occurred more frequently, but were not significantly different between treatments or strains.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 556 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- LOAEL
- Effect level:
- 1 556 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The developmental toxicity was tested in a read-across study with tertiary butanol. The NOAEL based on teratogenicity was determined to be >= 1556 mg/kg bw/day.
- Executive summary:
The developmental toxicity was tested in a read-across study with tertiary butanol. Pregnant mice were given tertiary butanol by gavage twice daily from day 6 through day 18 of gestation. Examinations were made on day 18. The females were sacrificed on day 18 by decapitation. The following concentrations were used: 20 mL/kg bw/day of a 10 % (v/v) solution equivalent to 1556 mg/kg bw/day (Basis=nominal conc. 10.5 mmoles/kg bw (=778 mg/kg bw every 12 hours). Two different strains were used to determine the toxicity: CBA/J (7 females control and 12 females test item) and C57BL/6J (5 females control and 9 females test item). The ovaries and uterine content was examined by determining the number of implantations, the number of resoprtions and number of live fetuses. Also fetal examinations were performed by determining soft tissue examinations, skeletal examinations and the mean fetal weight. As a result the NOAEL was determined to be >= 1556 mg/kg bw/day based on teratogenicity. The LOAEL was determined to be 1556 mg/kg bw/day based on embryotoxicity. No maternal toxicity was observed during the study. Tertiary butanol produced a significant increase in the number of resorptions per litter, F(1,29)=7.361, p.=0.011, and a significant decrease in the number of live fetuses per litter, F(1,29)=10.060, p.=0.004. There were no significant effects of strain on either the number of resorptions per litter, F(1,29)=0.07, p.=0.787, or the number of live fetuses per litter, F(1,29)=0.322, p.=0.575. Eight of the 21 litters in the t-butanol treated groups had all of the fetuses resorbed vs.none in the control groups (X2=4.10, p.<0.05). Significantly more of the resorptions in the treated groups (33/75) required ammonium sulfide for visualization than in the control groups (2/14) (X2=4.66, p.<0.05), suggesting an early effect on fetal viability. No inter-strain differences in fetal mortality were observed. There was a slight but statistically insignificant decrease in the weight of the surviving fetuses in both strains. The results of morphological examination of the surviving offspring: Soft tissue examination revealed no teratogenic effects of t-butanol in either strain. There was no evidence that t-butanol produced the dilated ventricles, open eyelids, exencephaly, heart defects, or gastroschisis reported for ethanol in the CBA/J strain (27), even though fetuses were carefully examined for these defects. Skeletal examinations showed defects limited to the skull and sternum. Minor variations (misaligned or underossified sternebrae and underossified supraoccipital bones) occurred more frequently, but were not significantly different between treatments or strains.
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