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Diss Factsheets
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EC number: 205-487-5 | CAS number: 141-52-6
- 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
Neurotoxicity
Administrative data
- Endpoint:
- neurotoxicity: short-term inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A published study containing sufficient details to regard it as reliable for use in hazard assessment. Basic experimental detail provided. Route of exposure highly relevant.
Data source
Reference
- Reference Type:
- publication
- Title:
- Neurochemical but not behavioral deviations in the offspring of rats following prenatal or paternal inhalation exposure to ethanol.
- Author:
- Nelson BK, Brightwell WS, Mackenzie-Taylor DR, Burg JR, Massari VJ
- Year:
- 1 988
- Bibliographic source:
- Neurotoxicol Teratol 10, 15-22.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Behavioural study
- Deviations:
- yes
- Remarks:
- yes low number of pregnant females; no necropsy or pathology conducted; males treated prior to mating
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: females 176-200g; males >300g
ENVIRONMENTAL CONDITIONS
- Temperature: 24+/-2°C
- Humidity: ~40%
- Photoperiod: 12hr light/dark cycle.
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- other: air in chamber
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure was conducted in 0.5m3 chambers with dynamic air flow (one air change per minute.) Dosing method described in detail.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- IR analyser - exposures found to be +/-200ppm of nominal. Independently cross-checked with charcoal adsorption tubes analysed by gas chromatography.
- Duration of treatment / exposure:
- Exposure period: 7 hours /day
Premating exposure period (males): 6 weeks
Premating exposure period (females): none
Postmating exposure period (females): Days 1-19 of gestation - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10000, 16000pm
Basis:
nominal conc.
- No. of animals per sex per dose:
- Females, 15 per group, males,18 per group.
- Control animals:
- yes
- Details on study design:
- Duration of test: see method details
Examinations
- Observations and clinical examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes, as measures of maternal toxicity.
WATER CONSUMPTION AND COMPOUND INTAKE: Yes, as measures of maternal toxicity.
- Time schedule for examinations: - Other examinations:
- All litters weighed within 16 hrs. Litters less than 3 pups per sex discarded. Offspring weighed on PND 7 and checked for abnormalities
- Statistics:
- Behavioral data were analyzed using multivariate analysis of variance or an m-ranking procedure. Repeated measures analyses were conducted where appropriate to p<0.05. Neurochemical data were analyzed using Analysis of Variance followed by Duncan's Multiple Range post-hoc tests where a significance was found.
Results and discussion
Results of examinations
- Details on results:
- No effect on weight gain. Feed intake retarded during 1st week but normal thereafter at 16000ppm. No effects on litter size, still births, length of pregnancy, offspring survival. No effect observed in behavioural study tests. No effect on dopamine, substance P, beta-endorphin and acetylcholine levels. Significant effects on norepinephrine, 5-hydroxytryptamine but magnitude and direction of changes not correlated with dose. Level of Met-enk phalin affected at lower but not higher dose.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 600 ppm
- Basis for effect level:
- other: no effects observed
- Remarks on result:
- other: Generation: maternal (migrated information)
- Dose descriptor:
- NOEL
- Effect level:
- < 1 000 ppm (nominal)
- Basis for effect level:
- other: Significant changes in 5-hydroxytryptamine levels in different parts of the brain.
- Remarks on result:
- other: Generation: other: - Neurotransmiter levels in offspring brain (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 600 mg/m³ air (nominal)
- Basis for effect level:
- other: No effects observed
- Remarks on result:
- other: Generation: other: - Behavioural development (migrated information)
Any other information on results incl. tables
Males: weight gain retarded during 1st week but normal thereafter.
Control values of behavioural results are described in Nelson et al 1985. Neurobehavioral Toxicology and Teratology, 7, 779 -783, 1985.
Applicant's summary and conclusion
- Conclusions:
- Ethanol treatment did not affect the performance of offspring in behavioural tests. Some biochemical changes were observed in the brain but not dose related and not cosistent across brain regions.
- Executive summary:
Male Sprague-Dawley rats were exposed 7 hours per day for six weeks to 10,000 or 16,000ppm ethanol by inhalation and then mated with untreated rats. Pregnant females received the same experimental treatment from day 1 -19 of gestation and were allowed to deliver their offspring. Treatment with ethanol did not affect the weight gain of parental animals. Offspring from paternally or maternally exposed animals performed as well as controls in tests of neuromotor coordination, activity levels, and learning ability. Levels of acetylcholine, dopamine, substance P, and beta-endorphin were unchanged in the brain in the offspring of ethanol exposed rats. Complex, but significant changes in the levels of norepinephrine occurred only in paternally exposed offspring. 5 -Hydroxytryptamin levels were reduced in the cerebrum, and met-enkephalin levels were increased in all brain regions of offspring from both maternally and paternally exposed rats.
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