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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- 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)
- Rationale for reliability incl. deficiencies:
- other: acceptable study, meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- The effects of long-term oral administration of ethanol on Sprague-Dawley rats - a condensed report
- Author:
- Holmberg B and Ekstrom T
- Year:
- 1 994
- Bibliographic source:
- Toxicology 96 (1995) 133-145
Materials and methods
- Principles of method if other than guideline:
- 2-year bioassay of ethyl alcohol in a semisynthetic liquid diet given to Sprague-Dawley rats
- 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:
- test substance: ethanol
- Supplier: Kemetyl AB, Stockholm.
- Analytical purity: 99.5% spectroscopically pure
- Impurities (identity and concentrations): < 100 mg methanol/l, < 1 mg cyclohexane/l, and maximum 1 mg fusel/l
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ALAB AB, Sollentuna, Sweden
- Age at study initiation: 6 and 7 weeks of age
- Housing: individually
- Diet (e.g. ad libitum): liquid diet adapted for rat nutritional purposes based upon a semisynthetic liquid human parenteral diet, Nutrauxile (Kabi Vitrum AB, Stockholm).; ad libitum
- Water (e.g. ad libitum): water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Ethyl alcohol - 1% (w/w) or 3% (w/w) - was added to the liquid diet and 20.2 g or 62.0 g glucose diet was added to serve as equicaloric controls - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 3% w/w ethanol
Basis:
nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- other: diet with additional glucose content (high and low)
- Details on study design:
- - Dose selection rationale: based on data of a 13-week dose-range finding study (Holmberg et al., 1986)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: every week during the first 13 weeks, then every second week thereafter
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: end of study
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
The median survivals for males were 105 weeks for low glucose, 104 weeks for high glucose, 110 weeks for low ethanol, and 105 weeks for high ethanol males. For females the corresponding figures were: low glucose 103 weeks, high glucose 94 weeks, low ethanol 101 weeks and high ethanol 109 weeks.
BODY WEIGHT AND WEIGHT GAIN
Low ethanol males had a similar body weight development as the corresponding control. High ethanol males had lower body weights (P < 0.005) from week 13 than had the high glucose males. Low ethanol females had a body weight development, which was similar to the low glucose females. For high ethanol females there was a statistically significant lower (P < 0.05) body weight from week 69 than in the controls.
DIET CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
The total diet consumption of low ethanol diet was higher than for low glucose among males, but not statistically significant. The consumption of high ethanol diet among males was lower (P < 0.05) than the consumption of the high glucose diet. For females, the total diet consumption among low ethanol animals was slightly higher than for the low glucose controls. For high ethanol females the diet consumption was significantly higher (P < 0.01) than for the high glucose control.
ORGAN WEIGHTS
There were no statistically significant differences in liver or kidney weights between the groups compared.
HISTOPATHOLOGY:
For male rats no neoplastic lesions were observed to be related to ethanol exposure.
For females, when liquid diet individual group comparisons were made, an increase in mammary gland tumors was seen for females receiving the low ethanol containing diet. Liver and bile duct injury was seen among males. Inflammatory reactions were among males in pancreas and for females in the clitoral gland. Hyperplasia was observed in the thyroid gland in both sexes and in the adrenal glands among females. Peripheral nerve degeneration was common in both sexes. Unlike males, females had centrilobular hepatic necrosis in a certain fraction of the animals (this was not a significant difference).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 3 other: %
- Sex:
- male/female
- Basis for effect level:
- other: body weight; histopathology
- Dose descriptor:
- LOAEL
- Effect level:
- 3 other: %
- Sex:
- male/female
- Basis for effect level:
- other: body weight; histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- > 3 600 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: body weight; histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.