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Diss Factsheets
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EC number: 902-053-3 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable, study with good documentation to demonstrate that study meets required scientific principles and contains enough detail to be able to judge the results reliable as a contribution to the understanding of the repeat dose toxicity of this substance. Not all end points were covered (no haematology, limited clinical chemistry). SIngle sex used.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study was a range finder to find appropriate doses for a chronic cancer study. The study followed the basic principles of an OECD408 sub-chronic study. Two study groups were used, details of the first range finder group are not reported here. Only male rats used. No haematology or urinalysis and limited clinical chemistry performed.
- 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
- Source: Svenska Spirit AB, Stockholm.
- Analytical purity: Spectroscopically pure
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 43 days. Controls and 5% ethanol dose animals run concurrently with controls used 70 day old animals
- Housing: individual. Cages rotated within room to a fixed schedule.
- Food: liquid diet based on Nutrauxil, a semi-synthetic liquid enteral diet for humans, modified to give the rats an adequate diet in the absence of solid food. 70ml/day provided per animal
- Water: not separately given.
Administration / exposure
- Route of administration:
- other: mixed with liquid feed
- Vehicle:
- other: rat adapted Nutrauxil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Ethanol supplied in nutritionally balanced liquid diet.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days unless study terminated early
- Frequency of treatment:
- continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 2, 3, 4, 5%, 10% w/v ethanol in liquid diet
Basis:
- No. of animals per sex per dose:
- 10 (20 in controls)
- Control animals:
- other: two control groups. One with liquid diet only and second with glucose added equicaloric to 10% ethanol. Note that controls were run in the pre-study, ie not concurrently.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS/CLINICAL OBSERVATION: Yes
- Time schedule: not reported.
- Cage side observations checked: no data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Time schedule for examination: daily
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination from iliac bifurcation.
- Animals fasted: no data
- How many animals: all
- Parameters checked: AST and ALT activities only
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- Liver and kidneys were weighed, examined macroscopically and microscopically at necropsy. Spleen was weighed.
- Statistics:
- No statistical tests for significance were used.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Details on results:
- FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
See table below. No indication of statistical significance
GROSS PATHOLOGY
Liver yellowing was observed in some of the 3 and 4% dose animals and most of the 5% dose animals. It was considered to be dosage-related.
HISTOPATHOLOGY: NON-NEOPLASTIC
A centrilobular and hepatic steatosis was seen in all rats in all groups. The severity increased with increasing ethanol concentration both in terms of numbers of animals affected and in degrees of changes in each animal (see table below). In the control and two lowest dose groups, there was no occurance of Mallory bodies or acidophilic degeneration or necrosis but these were seen in the higher dose groups. Very slight Reticulo-endothelial cell proliferation and occurence of acidophilic bodies were seen in both control and the lower 2 dose groups but were seen at moderate levels in the higher dose groups. In the kidney, nephrocalcinosis was seen in both controls and dosed animals; the effects were not significant. Tubular fatty changes were also seen in the kidney. These were seen as very slight in about 25% of both controls and the 1% dose animals. They were seen in about 75% of the 2-4% dose animals (and all except 1 of the high dose animals) but the degree of severity showed no dose response relationship.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 other: % in liquid diet
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 3 other: % in liquid diet
- Sex:
- male/female
- Basis for effect level:
- other: liver changes (Mallory bodies)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Food consumption
Dose | litres food/kg bw animal per week |
Liquid diet | 1.13 +/-0.061 |
Liquid diet + glucose | 0.847 +/-0.09 |
1% ethanol | 1.409 +/-0.31 |
2% ethanol | 1.363 +/-0.308 |
3% ethanol | 1.357 +/- 0.313 |
4% ethanol | 1.315 +/-0.302 |
5% ethanol | 1.272 +/- 0.24 |
5% ethanol | 0.709 +/-0.080 |
* run at same time as controls
Centrilobular steatosis
Dose | # animals |
none | very slight |
slight | slight to moderate |
moderate | rather severe |
Liquid diet | 19 | 19 | |||||
Liquid diet + glucose | 19 | 2 | 2 | 8 | 7 | ||
1% ethanol | 10 |
2 | 5 | 3 | |||
2% ethanol | 10 | 2 | 3 | 5 | |||
3% ethanol | 10 | 1 | 5 | 4 | |||
4% ethanol | 10 | 4 | 6 | ||||
5% ethanol | 10 | 1 | 5 | 4 | |||
5% ethanol* | 20 | 3 | 8 | 3 | 6 |
* run at same time as controls.
In the liver, hyaline bodies (Mallory bodies), together with centrilobular steatosis and necrotic areas, are considered evidence of irreversible liver injury which can lead to cirrhosis. These were only seen in the 4 and 5% dose animals.
Applicant's summary and conclusion
- Executive summary:
In a 90 day sub-chronic repeat dose study, male rats were given a liquid diet containing ethanol at a level of 1 -5% by weight. The only significant effect seen in the 1 and 2% dose groups were centrilobular steatosis. This is often associated with ethanol consumption but in its mild form is not considered to be a pathological condition. There was also evidence from glucose dosed animals, used as calorific controls which also showed the effect, that this finding is actually related to the caloric content of ethanol rather than being substance specific. It is not therefore considered an adverse effect. On this basis, the no effect level from this study was 2%, which was approximately equivalent to a dose of 3900mg/kg/day. It should be noted that the study did not conform fully to a guideline study in that a number of end points, e.g. haematology and urinalysis, were not carried out and only partial clinical chemistry and organ pathology/histology was undertaken. Notwithstanding this, the study did concentrate on the likely known toxicity targets for this substance.
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