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Diss Factsheets
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EC number: 219-323-5 | CAS number: 2414-98-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A published study which contains sufficient experimental detail to be able to judge it as reliable. Basic experimental detail provided.
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratological assessment of methanol and ethanol at high inhalation level in rats.
- Author:
- Nelson, B., Brightwell, W., MacKenzie, D., et al.
- Year:
- 1 985
- Bibliographic source:
- Fundam Appl Toxicol 5:727-736.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- low number of pregnant females, no detailed examination of dams
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- - Name of test material (as cited in study report): ethanol absolute-200 proof
- Analytical purity: 96.5%
- Impurities (identity and concentrations): Analysis for water and benzene detected none.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: not stated
- Weight at study initiation: 200-300g
- Fasting period before study: no
- Housing: 3 per cage in stainless-steel cages except whilst in chamber
- Diet (e.g. ad libitum): purina or comparable-grade lab chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:1-2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24
- Humidity (%): 20-60
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: air in chamber
- Details on exposure:
- 0.5m3 Hinner-type exposure chambers under negative pressure. Controls were placed in similar cage as the exposed animals with adjacent exposure chamber for the same hours.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Two methods used: Continuously by a Miran 1A general purpose infrared analyzer (Wilkes/Foxboro Analytical), on an hourly basis; and concentration samples taken from chamber atmosphere by charcoal tube. Sampling times 10-30 mins. 5-10 samples/week. Analysed by NIOSH 1977b-No. S-56 Method with slight modifications.
- Details on mating procedure:
- Virgin females were housed with males and vaginal smears were taken.
- Duration of treatment / exposure:
- 7 hours per day in exposure chamber on gestation days 1-19. Animals left in the chambers for degassing for approximately 1/2 hr after vapor generation terminated.
- Frequency of treatment:
- daily
- No. of animals per sex per dose:
- not explicitly stated but approximately 16.
- Control animals:
- not specified
- Details on study design:
- Sex: female
Duration of test: Days 1-19 of gestation
Examinations
- Maternal examinations:
- Blood levels
- Ovaries and uterine content:
- No maternal organs were examined
- Fetal examinations:
- Foetuses were examined externally and internally for malformations; implants and resorptions were recorded as was litter weight.
- Statistics:
- Kruskal-Wallis analysis of variance or Fisher's test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
No mortality occurred. Food consumption was lowered in the high-dose group. Clinical signs observed included complete narcosis (described as severe toxicity) in the highest dose induced. The lower doses did not cause narcosis but caused hyperactivity after exposure. Maternal weight gains were not affected by treatment. Blood alcohol levels ranged from 0.02 to 0.03 mg/ml at 10000 ppm, 0.42 to 0.84 mg/ml at 16000ppm and 1.48 to 1.93 mg/ml at 20000 ppm. Measurements were made on non-pregnant rats and represent the ranges of the average values measured at days 1, 10 and 19.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 16 000 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 20 000 ppm
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The number of pregnant per dose level were 15/15, 15/15, 15/16 and 14/16 in the control, low, medium and high dosage groups. The number of resorptions were not affected by ethanol inhalation. The number of implantations were 14-16/litter in all ethanol-treated groups and 15/litter in the control group. The number of corpora lutea were 14-16/litter. LItter weights were not significantly affected by ethanol treatments. The sex ratio did not differ significantly from controls. Grossly visible abnormalities are given in detail but the frequency of each did not differ significantly between groups. More litters contained abnormal foetuses in the 20,000 ppm group compared to controls but differences were only of borderline statistical significance.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 20 000 ppm
- 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
Maternal LOAEL effect was narcosis and lowered food consumption.
Development LOAEL effect – none seen
Development NOAEL effect – visceral or skeletal malformations or variants.
Maternal data are not given for the following: Number aborting; (Duration of pregnancy not relevant); bodyweights; haematology and blood chemistry findings; gross pathology in dams; organ weight changes; histopathology incidence and severity.
Foetal data are not given for the following: litter size; number viable; postnatal growth (not applicable) and postnatal survival (not applicable).
Applicant's summary and conclusion
- Conclusions:
- No definite evidence of malformations due to ethanol exposure were seen although the incidence of abnormal changes at the highest concentration was of borderline statistical significance. There was clear maternal toxicity at this concentration however.
- Executive summary:
Pregnant female rats were exposed to ethanol by inhalation at concentrations of 10000, 16000, or 20000ppm in a chamber for 7 hours per day on gestation days 1 -19. On day 20 the animals were euthanized and their fetuses examined. There was no definite increase in malformations at any level of ethanol exposure, although the incidence in the 20000ppm group was of borderline significance. There was clear maternal toxicity evident at the highest dose (narcosis, food intake reduction).
Synposis
NOAEL (maternal toxicity) :16,000ppm (30,400mg/m3)
NOAEL (teratogenicity): 20,000ppm (38,000mg/m3)
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