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Diss Factsheets
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EC number: 267-135-7 | CAS number: 67801-15-4
- 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
Endpoint summary
Administrative data
Description of key information
Acute Toxicity - Oral and Dermal studies
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Feb - Mar 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols with no minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. Assigned reliability score of 2 on the basis that the test substance is being used for read-across.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- (High dose group of 1000 mg/kg)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK
- Age at study initiation: approximately six to eight weeks old
- Weight at study initiation: males weighed 178 to 211g, the females weighed 152 to 173g
- Fasting period before study:
- Housing: groups of three by sex in solid floor polypropylene cages with stainless steel mesh lids and softwood flake bedding (Datesand Ltd, Cheshire, UK).
- Diet (e.g. ad libitum): Pelleted diet (Rodent 2014C Teklad Global Certified Diet, Harlan Laboratories U.K. Ltd., Oxon, UK ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2ºC
- Humidity (%): 55 ± 15%
- Air changes (per hr): at least fifteen air changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
- Doses:
- 100, 500 and 1000 mg/kg/day
- No. of animals per sex per dose:
- 3 per sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: All animals were examined for overt signs of toxicity, ill health or behavioural change immediately before dosing, up to thirty minutes after dosing and one hour after dosing. Additional observations were also made five hours following dosing whenever possible. Observations taken for 14 days.
- Necropsy of survivors performed: yes. On completion of the dosing period, all animals were killed by intravenous overdose of a suitable barbiturate agent followed by exsanguination and subjected to an internal and external macroscopic examination. No tissues were retained.
- Other examinations performed: clinical signs, body weight. - Statistics:
- Data were processed to give individual animal/group mean values, standard deviations and incidence of findings where appropriate.
- Preliminary study:
- n/a
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no effects observed
- Mortality:
- There were no unscheduled deaths during the study.
- Clinical signs:
- other: Incidents of increased salivation were evident throughout the treatment period in animals of either sex treated with 1000 and 500 mg/kg/day. Observations of this nature are commonly observed following oral administration of an unpalatable test material fo
- Gross pathology:
- There were no treatment-related macroscopic abnormalities detected at necropsy.
- Other findings:
- n/a
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The oral administration of Ebanol to rats for a period of seven consecutive days at dose levels of 100, 500 and 1000 mg/kg/day produced no toxicologically significant effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) and a suitable high dose level for use on future toxicity studies was, therefore, considered to be 1000 mg/kg/day.
- Executive summary:
The oral administration of Ebanol to rats for a period of seven consecutive days at dose levels of 100, 500 and 1000 mg/kg/day produced no toxicologically significant effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) and a suitable high dose level for use on future toxicity studies was, therefore, considered to be 1000 mg/kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute – Oral
Key Study for Acute Oral In Vivo (Harlan Laboratories, 2010, OECD Guideline 423).
The oral administration of Ebanol to rats for a period of seven consecutive days at dose levels of 100, 500 and 1000 mg/kg/day produced no toxicologically effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) was therefore >1000 mg/kg/day. The supporting study by Leberco Laboratories in 1984 (EPA OPP 81-1) showed that the LD50 of Ebanol in rats was >5000 mg/kg.
On the basis that the test substance (Ebanol) is being used to support Ebanone on the basis of read-across, the NOAEL values for Ebanone were also considered to be >5000 mg/kg bw (oral).
Justification for classification or non-classification
Justification for classification or non classification
Based on the oral LD50 value >1000 mg/kg bw (supporting data >5000 mg/kg), there is no need to classify Ebanol for acute toxicity in accordance with the criteria outlines in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
On the basis that the test substance (Ebanol) is being used to support Ebanone on the basis of read-across, 3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-2-one is also considered to be unclassified.
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