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EC number: 939-200-6 | CAS number: -
- 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:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the Prenatal Toxicity of 3-Methyl-1-butanol and 2-Methyl-1-propanol in Rats and Rabbits Following Inhalation Exposure
- Author:
- Klimisch H.J. and Hellwig, J.
- Year:
- 1 995
- Bibliographic source:
- Fundamental and Applied Toxicology 27, 77-89 (1995)
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Fifteen female rabbits per group were exposed to 2-Methyl-1-propanol vapours at concentrations of 10, 2.5, or 0.5 mg/L, 6 hr/day. The rabbits were exposed on Days 7 -19 postinsemination . Control groups were exposed to clean air. The body weights of the animals were determined several times throughout the studies. All rabbits were killed on Day 29 postinsemination. The foetuses were removed from the uterus and examined for compound-related effects.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-Methyl-1-propanol
- IUPAC Name:
- 2-Methyl-1-propanol
- Reference substance name:
- 2-methylpropan-1-ol
- EC Number:
- 201-148-0
- EC Name:
- 2-methylpropan-1-ol
- Cas Number:
- 78-83-1
- IUPAC Name:
- 2-methylpropan-1-ol
- Reference substance name:
- Isobutanol
- IUPAC Name:
- Isobutanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-Methyl-1-propanol
- Molecular formula (if other than submission substance): Not reported
- Molecular weight (if other than submission substance): Not reported
- Smiles notation (if other than submission substance): Not reported
- InChl (if other than submission substance): Not reported
- Structural formula attached as image file (if other than submission substance): see Fig. Not reported
- Substance type: Not reported
- Physical state: Not reported
- Analytical purity: 2-Methyl-1-propanol 99.8%
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Stable for at least 6 months
- Storage condition of test material: Not reported
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach/Riss, Germany
- Age at study initiation: 24 - 29 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Fasting period before study: None
- Housing: Individually in wire cages
- Diet (e.g. ad libitum): KLIBA rabbit laboratory diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: Not reported To: Not reported
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- clean air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Horizontal-flow whole-body exposure chamber
- Method of holding animals in test chamber: Not reported
- Source and rate of air: Not reported
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: Concentrations were achieved by supplying the test substances via continuously operating pumps to evaporators maintained at 50-70°C by a water circulation thermostat.
- Temperature, humidity, pressure in air chamber: Supply and exhaust air flows were adjusted by flow meters, in order to achieve a minimal negative pressure in the inhalation chamgers. Temperature was 21-24°C amd relative humidity was 49-60%
- Air flow rate: 15 air exchanges per hour
- Air change rate: 15 air exchanges per hour
- Method of particle size determination: Not reported
- Treatment of exhaust air: Not reported
TEST ATMOSPHERE
- Brief description of analytical method used: Samples of inhalation atmospheres were analysed houly by gas chromatography.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of inhalation atmospheres were analysed houly by gas chromatography.
- Details on mating procedure:
- The rabbits were fertilized by artificial insemination; the day of insemination was defined as Day 0 and the following day was defined as Day 1 postinsemination
- Duration of treatment / exposure:
- Daily for 6 hours/day from days 7 - 19 postinsemination.
- Frequency of treatment:
- Daily for 6 hours/day
- Duration of test:
- After termination of the exposure period, the rabbits were observed up to Day 29 postinsemination.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5, 2.5, 10 mg/L, 6 hr/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 15 females/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No further data on dosing rationale.
The animals were randomly allocated to the test groups.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations: state of health
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 3 and 7 and from then on at 3-day intervals until Day 29 postinsemination
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on Day 29 postinsemination
- Organs examined: Uterus and ovaries were removed for the following delerminations: intact uterine weight, number of corpom lutea, and number of
implants, the latter being differentiated into live fetuses and dead implants (early and late resorptions, dead fetuses). The pre- and postimplantation losses were calculated. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- 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: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: No data - Statistics:
- The Dunnett test was used to statistically compare body weight, body weight changes, corrected body weight gain, intact uterine weight, fetal and placental weights, the number of corpora lutea. implants, resorptions, live fetuses, and pre- or postimplantat ion losses. The Fisher's exact test was used for evaluating the conception rate, maternal mortality, and all fetal findings.
- Indices:
- No further data
- Historical control data:
- No further data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: slight maternal toxic effects at the highest dose (10 mg/L) of 2-Methyl-1-propanol
Details on maternal toxic effects:
Only slight maternal toxic effects were induced in Himalayan rabbits after exposure to 10 mg/L of 2-Methyl-1-propanol
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 2.5 mg/L air
- Based on:
- other: 2-Methyl-1-propanol
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 mg/L air
- Based on:
- other: 2-Methyl-1-propanol
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No treatment related effects. All effects were concidered incidental and were within the normal variations for the species.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 mg/L air
- Based on:
- other: 2-Methyl-1-propanol
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 mg/L air
- Based on:
- other: 2-Methyl-1-propanol
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 mg/L air
- Based on:
- other: 2-Methyl-1-propanol
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No further data
Applicant's summary and conclusion
- Conclusions:
- The highest concentration of 10 mg/L appeared to be a borderline concentration for causing maternal toxicity. 2.5 mg/L was therefore the NOAEL after exposure to 2-Methyl-1-propanol.
The highest concentration level of 10 mg/L was found to be a clear NOAEL for the fetal organisms. - Executive summary:
Fifteen female rabbits per group were exposed to 2-Methyl-1-propanol (isobutanol) vapours at concentrations of 10, 2.5, or 0.5 mg/L, 6 hr/day. The rabbits were exposed on Days 7 -19 postinsemination. Control groups were exposed to clean air. The body weights of the animals were determined several times throughout the studies. All rabbits were killed on Day 29 postinsemination. The foetuses were removed from the uterus and examined for compound-related effects. The high concentration of 10 mg/L caused a slight retardation of body weight gain in the dams exposed to 2-Methyl-1-propanol during the first days of the exposure period.. The foetuses exhibited no signs of embryotoxicity, fetotoxicity or teratogenicity effects caused by 2-Methyl-1-propanol. Under the experimental conditions, 2.5 mg/L was found to be a no-observable-adverse-effect level (NOAEL) for the dams exposed to 2-Methyl-1-propanol. For both substances 10 mg/L was defined as the NOAEL for the conceptuses.
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