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EC number: 212-741-9 | CAS number: 865-48-5
- 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:
- one-generation reproductive toxicity
- 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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Quantitative Comparison of Maternal Ethanol and Maternal Tertiary Butanol Diet on Postnatal Development
- Author:
- Daniel, MA and Evans, MA
- Year:
- 1 982
- Bibliographic source:
- The Journal of Pharmacology and Experimental Therapeutics 222: 294-300
Materials and methods
- Principles of method if other than guideline:
- The published study was designed to evaluate the effects of maternal exposure to t-butanol during gestation or postnatal development. For that, pregnant mice were fed liquid diets containing tertiary butanol in concentrations of 0.50, 0.75 and 1 % (w/v) from day 6 to day 20 of gestation. Postnatal development was analyzed in regard to maternal nutritional and behavioral factors.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylpropan-2-ol
- EC Number:
- 200-889-7
- EC Name:
- 2-methylpropan-2-ol
- Cas Number:
- 75-65-0
- Molecular formula:
- C4H10O
- IUPAC Name:
- 2-methylpropan-2-ol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 8-10 weeks
- Weight at study initiation: (P) 18-20 g
- Fasting period before study: no
- Housing: housed in groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 30-40 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: Maltose/dextrin in water
- Details on exposure:
- Animals were fed standard dry Iab chow diet and water ad libitum until day six of gestation. Afterwards, the diet was presented in standard water bottles ad libitum to the 1 % t-butanol group from day 6 to day 20. The other four groups were pair-fed based upon the consumption of 1% t-butanol. Intake was calculated by subtracting the weight remairring in the water bottles between 7 and 8 P.M. from the total supplied the previous day.
- Details on mating procedure:
- - M/F ratio per cage: 1/3
- Proof of pregnancy: sperm plugs were taken as day 1 of pregnancy
- After successful mating each pregnant female was caged (how): no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- day 6 to 20 of gestation
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5, 0.75, 1 % (w/v)
Basis:
nominal in water
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Within 24 hr of parturition, litter size, weight and viability were recorded. Approximately one-half of the maternal mice in each group were replaced with Iab chow-fed maternal animals which had delivered a litter within 24 hr of the time the treatment or control groups delivered. Litten were adjusted to a maximum of 5 per maternal animal. Subsequently, 4 fostered and 4 maintained with the original maternal animal were selected from each of the treatment groups for the behavioral tests. In the 1 % t-butanol group, only six litters, three fostered and three maintained with the original maternal animal, were selected for study.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Cage side observations checked: mortality
BODY WEIGHT: Yes
- Time schedule for examinations: day 5, 10, 15 and 20 of pregnancy
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes, intake was determined by subtracting the weight remaining in the water bottles between 7 and 8 P.M. from the total supplied the previous day. All bottles were replaced with clean bottles and fresh diet every 24 hr.
Other: length of gestation was determined - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- Gross structural anomalies and number of deaths were recorded within 24 hr of parturition. Weight, pinna detachment, eye opening and behavior were recorded every two days from day 2 until day 10. Roto-rod evaluations were made every other day from day 14 to day 22, inclusive. The following endpoints were recorded: Righting reflex, negative geotaxis, open filed behavior, cliff avoidance, Roto-rod performance
- Postmortem examinations (parental animals):
- No data
- Postmortem examinations (offspring):
- Gross structural anomalies and number of deaths were recorded.
- Statistics:
- Statistical analyses were performed using each animal as the unit of analyses. The N value for each treatment group was 28 representing four litters with seven pups/ litter except for the 1 % t-butanol treatment group which had an N value of 15 (three Iitters with 5 pups/ liter). Linear regression
analyses was performed for each behavioral test procedure using the log dose of t-butanol diet (w/v) vs. the mean of the test score for each animal. The F test was used toassess the significance between the regression coefficients of scores from maternal and fostered pubs.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS): A slight decrease in maternal diet intake occurred at the higher butanol concentrations (0.75 and 1 %) which resulted from difficulties in pair feeding and increased maternal sedation.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS): no data
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS): no data
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): no data
ORGAN WEIGHTS (PARENTAL ANIMALS). no data
GROSS PATHOLOGY (PARENTAL ANIMALS): no data
HISTOPATHOLOGY (PARENTAL ANIMALS): no data
Results: F1 generation
Details on results (F1)
Negative geotaxis was proved to be unreliable because circling occurred in all groups. Except for the righting reflex, no significant difference in postnatal hehavior scores could be detected between the pups of the control and treatment groups. Weight, cliff avoidance, righting reflex, open field behavior and roto-rod performance showed treatment-related effects. A statistically significant maternal behavior or postnatal nutrition-related developmental delay was detected in the 0.75 and 1 % t-butanol group regarding body weight gain.
The righting reflex of 0.75% t-butanol and 1 % t-butanol groups was not as well developed compared to the maltose/dextrin control. The righting reflex showed a dose-response correlation and a significant difference between fostered and nonfostered pups, indicating a significant postnatal maternal nutritional and behavioral effect. Similar results were obtained in the open field analysis.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 0.5 other: %
- Based on:
- test mat.
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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